RULES AND REGULATIONS
DEPARTMENT OF HEALTH
[ 28 PA. CODE CH. 23 ]
[47 Pa.B. 1300]
[Saturday, March 4, 2017]
The Department of Health (Department), with the approval of the Advisory Health Board (Board), amends Chapter 23, Subchapter C (relating to immunization) to read as set forth in Annex A.
A. Purpose and Background
This final-form rulemaking amends the Department's requirements for school immunizations and is based, in part, upon recommendations of the Advisory Committee on Immunization Practices (ACIP), an advisory committee of the Federal Centers for Disease Control and Prevention (CDC). This final-form rulemaking replaces the 8-month provisional period for immunizations with a new requirement. Previously, the regulations allowed a child to be provisionally admitted to school even though the child did not have all the required immunizations for entry or continued attendance as set out in § 23.83 (relating to immunization requirements) for 8 months before facing exclusion.
This final-form rulemaking requires a child to have any single dose vaccine upon school entry, or risk exclusion. In the case of a multidose vaccine, this final-form rulemaking requires that the child have at least one dose of the vaccine upon school entry. If additional doses are required and are medically appropriate within the first 5 days of school, the child shall have either the final dose during that 5-day period, or shall have the next scheduled dose and shall also provide a medical certificate setting out the schedule for the remaining doses. If the child has at least one dose, but needs additional doses, and those doses are not medically appropriate during the first 5 days of school, the child may provide a medical certificate on or before the 5th school day scheduling those doses.
The medical certificate shall be signed by a physician, certified registered nurse practitioner (CRNP) or physician assistant (PA). If the child will be receiving the immunizations from the Department or a public health department, a public health official may sign the medical certificate. A child who meets these requirements may continue to attend school even if the child does not have all the required vaccinations, so long as the child complies with the vaccination schedule in the medical certificate. School administrators or their designees are required to review that medical certificate every 30 days to ensure that the child is in compliance. Even with this final-form rulemaking, the child still has the ability to be exempted from the immunization requirements if the child has a medical or religious/philosophical exemption. This final-form rulemaking also provides for certain waivers of the regulation under specified conditions—for example, if the child is homeless or if the child is unable to locate his records due to a disaster.
This final-form rulemaking also adds a dose of meningococcal conjugate vaccine (MCV) for entry into the 12th grade or, in an ungraded class, for entry into the school year when the child turns 18 years of age. This is in accordance with ACIP's recommendations. The Department also adds pertussis to the list of diseases against which a child shall be immunized before entering and attending school; this acknowledges the fact that certain vaccines, like single antigen diphtheria, single antigen tetanus and single antigen pertussis vaccine, are not available in the United States. Children being immunized against diphtheria and tetanus in this Commonwealth prior to this final-form rulemaking were receiving diphtheria and tetanus toxoids and acellular pertussis (DTaP) in accordance with ACIP recommendations (unless the child had a contraindication for the pertussis vaccine or a religious/philosophical exemption) and are already receiving a pertussis component in their vaccinations.
This final-form rulemaking allows the Department to waive the immunization requirements in the case of a National vaccine shortage, or an emergency, and also provides a child transferring into school in this Commonwealth who is unable to provide vaccine records immediately to provide those records or an exemption within 30 days.
Finally, this final-form rulemaking changes the manner and time frames for schools to report immunization rates to the Department to ensure the most accurate immunization data possible from schools.
This final-form rulemaking also amends existing vaccine requirements to acknowledge that certain types of vaccine are no longer available in the United States, including changing the requirements allowing for either a single antigen vaccine for both diphtheria and tetanus and acknowledging that the acceptable immunization is a combination vaccine for diphtheria, tetanus and pertussis. This final-form rulemaking allows for a child with a contraindication for the pertussis component of the vaccine to obtain a combination diphtheria and tetanus vaccination. This final-form rulemaking also adds a second dose of MCV before entry to 12th grade.
This final-form rulemaking does not amend the requirements allowing a child to obtain an exemption from immunization requirements for either religious or medical reasons. Those requirements are statutory and may not be altered through the regulatory process.
Notice of proposed rulemaking was published at 46 Pa.B. 1798 (April 9, 2016), with a 30-day public comment period. The comments and the Department's responses follow.
B. Summary and Overview of General Comments
The Department received close to 300 letters of comment on the proposed rulemaking. Commentators included individual school nurses, physicians, chiropractors, parents, grandparents, members of the general public, vaccine manufacturers and interest groups such as the March of Dimes, the Pennsylvania Association of School Administrators (PASA), the Pennsylvania State Education Association (PSEA), the Pennsylvania School Boards Association (PSBA), the Pennsylvania Immunization Coalition (PAIC), the Home School Legal Defense Association (HSLDA), the National Meningitis Association (NMA) and the Pennsylvania Coalition for Informed Consent (PACIC). The Independent Regulatory Review Commission (IRRC) also commented.
The comments fell into several broad categories: general support for school immunizations; general opposition to required school immunizations; opposition to vaccines in general; concerns regarding the cost and benefit of vaccines in general, the meningococcal and pertussis vaccinations in particular; opposition to and support for the reduction of the provisional period; and opposition to and support for requiring a statement of history of varicella disease from a physician, CRNP or PA. There were also demands for Pennsylvania-specific data regarding numbers and costs of outbreaks of disease in this Commonwealth. Many commentators commented on specific sections of the proposed rulemaking. This preamble sets out those general comments as well as comments that are related to specific sections.
General comments in support of the proposed rulemaking
PAIC supported the proposed rulemaking. PAIC stated that it is critical to do all that can be done to maintain high rates of childhood/student immunizations, and that the proposed amendments to the immunization regulations would definitely increase ''community immunity'' in schools and communities, as well as more accurate data collection. PAIC also stated that the rulemaking would decrease the time and labor dedicated by school nurses to remind parents to complete required vaccine series.
The Department agrees with the commentator.
The March of Dimes supported the proposed rulemaking. The March of Dimes stated that it had led successful efforts to develop a vaccine for polio, which ultimately ended the polio epidemic in the United States. The March of Dimes further stated that the CDC declared vaccines to be one of the top ten public health achievements of the 20th century.
The Department agrees with the commentator.
PASA supported the Department's efforts to increase immunization rates of school-aged children to decrease the risk of exposure of communicable disease to students, staff, parents and visitors to public schools. According to PASA, inadequate immunization of school-aged children increases the potential for outbreaks and major disruption in student learning. PASA stated that this has the potential to increase the cost to taxpayers of operating schools during an outbreak by requiring schools to hire substitute teachers and other staff to fill in for staff impacted by the disease outbreak.
PASA also stated that the Department must balance the budgetary limitations and administrative capacity of school districts and other school entities to carry out the new requirements against the public health objective to maximize compliance with the regulations. PASA stated that the cost and paperwork estimates severely understated the increased administrative and paperwork burden on schools. PASA stated that since 2011, school districts have lost more than 23,000 positions due to budgetary reasons, including 600 administrators and administrative positions. Policy change that requires increased staff time to oversee, track, intervene and report on compliance with childhood immunization requirements will either require existing staff to shift existing priorities or require the school district to add staff, perhaps at the expense of addressing other critical needs. The positive intent of the amendments is too important to be lost in the administrative burden that will undoubtedly occur as school districts work to manage the myriad of unfunded mandates that are passed down in the form of regulations and legislation.
The Department appreciates PASA's support of the Department's public health objective. The Department is aware of the budgetary and administrative concerns of schools and school districts. The Department notes that according to the comments received from many school nurses throughout this Commonwealth, the implementation of this final-form rulemaking will fall on them. According to those school nurses, they are the school staff that are currently checking immunizations, raising exclusion issues and reporting to the Department. Yet PSEA, which provided comments supporting school nurses, did not raise an issue with respect to the shortening of time frames to review medical certificates from 60 days to 30 days, or with respect to reporting requirements. The Department acknowledges that the manner in which school districts are operated is within the purview of school districts, and that having school nurses perform these functions may not be how every school district functions. The Department cannot comment on how many positions in schools have been cut due to budgetary considerations or on how many of those positions were actually concerned with daily immunization compliance in schools.
PSEA supported the proposed rulemaking, although it stated that it understood and respected the concerns that were raised in some of the other public comments submitted to the Department. PSEA stated that it strongly supported the Department's effort to establish a sense of urgency around the issue of immunization by reducing the provisional period from 8 months to 5 days. PSEA stated that this Commonwealth can be proud of its record for immunizing school-aged children, but stated that more needed to be done to reach the herd immunization levels of 95% or greater recommended by the CDC. PSEA stated that this was particularly important for students who are immune-compromised to help reduce their exposure to infections that could have been prevented with a vaccine. According to the PSEA, ensuring that children are healthy is a critical factor for keeping them in school ready to learn. PSEA said that school nurses play an integral part in helping to protect children and entire school communities from vaccine preventable diseases.
PSEA urged the Department to implement evidence-based strategies to increase access to vaccinations where needed. PSEA lauded the Department's ''Don't Wait. Vaccinate.'' program, and urged the Department to work with schools and other community-based partners to increase awareness of this program for students and families.
PSEA also recommended that the Department consider school-located vaccination clinics in areas where there are gaps in providers or other challenges to providing vaccinations to increase vaccine rates by increasing direct access to care in schools. PSEA noted that school-based clinics could be an alternative to vaccination at a physician's office or a public clinic, and would reduce barriers to vaccine access because of family schedules, transportation, or concerns about additional copays or visits to providers.
The Department appreciates PSEA's support of its ''Don't Wait. Vaccinate.'' program, and its recommendations regarding how to increase access to vaccines. Unfortunately, the Department cannot offer school vaccination clinics as PSEA envisions. The Department can only provide vaccines to those children eligible for the Federal Vaccines for Children (VFC) Program. See sections 1902(a)(62) and 1928 of the Social Security Act (42 U.S.C.A. §§ 1396a(a)(62) and 1396s). The only children eligible for this program are children who meet one of a list of criteria. Two of those criteria are that the child shall be either uninsured or underinsured (that is, the insurance that the child has does not cover immunizations). See section 1928 of the Social Security Act. The Department does provide vaccine for ''catch-up'' clinics in schools for vaccine-eligible children if the school applies to the Department. The vaccine may only be given to those children who meet the eligibility criteria for the VFC Program. The Department will address the remainder of PSEA's comments as they apply to specific sections of the regulations.
One commentator, identifying himself as an infectious disease physician, stated that he absolutely agreed with the proposed amendments requiring children attending school to have the appropriate indicated vaccinations to prevent diseases such as measles and other vaccine-preventable diseases.
The Department agrees with the commentator.
One commentator, identifying herself as a school nurse, stated that the proposed amendments were minimal and would help school nurses maintain optimal immunization rates in this Commonwealth, as well as help dispel the misperception that vaccines cause autism and other related complications. The commentator stated that she would like the Department to take on the misinformation that is being spread by a vocal minority, the chiropractic community, as well as certain belief systems that immunizations cause disease rather than protect against it.
The Department thanks the commentator for her support and will address the question of vaccines and their relationship to disease as follows.
PSBA supported the Department's goals and approach to ensure that children are appropriately vaccinated to safeguard the school community from the spread of certain diseases, but stated that further refinement to the proposed rulemaking would give school districts sufficient time to update the mechanisms used to implement the amended regulations.
The Department appreciates PSBA's support and will address the remainder of PSBA's comments as they apply to specific sections of the regulations.
One commentator stated she was in full agreement with the immunization requirements because in her school district there was an outbreak of pertussis at the end of 2015 and ''it was a real mess.''
One commentator stated that she supported the proposed amendments because in her area there is an influx of students lacking adequate immunizations and there have been varicella, measles and pertussis outbreaks in her district and in surrounding areas.
One commentator, identifying herself as school nurse writing on behalf of children who are not immunized or who cannot be immunized for health-related reasons, relayed a situation with which she was currently dealing in a school. It involved a suspected case of mumps to which three unimmunized children were exposed. One of those children had leukemia and could not be vaccinated. According to the commentator, it was difficult to tell the parents of the child with leukemia that the potential case of mumps had not been confirmed by a serology test, because without that information a well-considered decision about whether to risk the vaccine for their child or risk the disease could not be made. The commentator pointed out that this also raised questions about excluding the other nonimmunized students who had exemptions based on strong moral and religious beliefs. She stated that parents were questioning the validity of the diagnosis and asking for conclusive information, which she did not have. She stated that if health care providers would have to confirm cases of communicable diseases by simple means such as serology, the course of action in this case would have been clear. She stated that she is still evaluating the impact of the suspected case of mumps on her school and hoping that no further cases arise.
The Department appreciates the support of these commentators.
One commentator supported the proposed rulemaking and the Department's efforts to reduce vaccine-preventable diseases in this Commonwealth. The commentator cited the World Health Organization, the CDC and other leading health authorities in stating that vaccines are one of the most valuable health innovations in modern times, and help save and improve the lives of people of all ages around the world. The commentator also cited the CDC as stating that if vaccine rates fall below a certain level, there may be an increase in vaccine-preventable diseases, even if these diseases are no longer common in the United States.
The Department appreciates this commentator's support and agrees that childhood immunizations play an important role in reducing the incidence of vaccine-preventable diseases.
General comments, recommendations and concerns
One commentator recommended that the Department simply adopt ACIP's recommendations regarding vaccinations by reference and avoid the need for the Department's updating of regulations every time ACIP makes a change to its recommendations. The commentator noted that this would take into account the fact that ACIP's recommendations evolve over time and would give the Department greater flexibility to modify vaccine requirements on an ongoing basis.
The Department considered this particular comment with regard to ACIP's recommendations on several previous occasions. After reviewing its previous responses, the Department will not revise the regulations as the commentator requested.
In determining what immunizations to require for school attendance, the Department reviews ACIP's guidelines and recommendations. The Department does not typically or uniformly accept or adopt all of ACIP's recommendations, either for the immunizations the Department will require, or for the standards applicable to those immunizations. ACIP's recommendations are helpful and often definitive but may not take into consideration issues that may be important to the adopting state jurisdiction.
Further, because ACIP's recommendations are based on the purely public health reason of protecting children from every possible disease, the group does not take into account the possibility of community reaction, nor should it. Practitioners, too, seeking to recommend the best health practices to their patients are not constrained by the need to accept and review public comment regarding the efficacy and necessity of obtaining a particular vaccine. Through this final-form rulemaking the Department is in the position of mandating that a child obtain a particular disease vaccine or be denied access to the educational system for some period of time. To that end, the Department must allow for the public to review and present its concerns regarding this mandate. For example, to have adopted the ACIP recommendations without further review would have mandated the provision of human papillomavirus (HPV) to students attending school without allowing for public comment. Regardless of one's position with respect to the efficacy of and necessity for receiving this particular vaccine, the HPV vaccine has given rise to some controversy and concern among the public.
In addition, there are groups of individuals who strongly disagree with any immunization of children, and many of them commented on the proposed rulemaking. Regardless of one's view of this issue, in the context of a regulation that requires immunizations for school attendance, rather than recommending them for personal health reasons, these persons, too, should have a meaningful opportunity to voice their concerns.
Adopting ACIP recommendations upon their issuance would raise other issues. Some immunizations for diseases that are not prevalent in this Commonwealth would involve unnecessary cost to patients. For example, with respect to the hepatitis A vaccine, although ACIP is careful to recommend vaccination against hepatitis A in states that are considered to be at high risk, a simple adoption of ACIP requirements would be insufficient to fully explain to the regulated community, that is, children, parents and guardians, and schools, whether the immunization is or is not required. These persons are unlikely to know that this Commonwealth is, in fact, not considered to be a high risk state for this disease due to low prevalence of hepatitis A disease. This would necessitate additional guidance from the Department in some form.
While the issuance of additional guidance does not, at first glance, appear to be overly burdensome, it is not the effect on the Department that raises the issue here. The Department attempts to make its school immunization regulations as simple as possible to aid schools and school nurses in their responsibilities to make certain only children who are appropriately vaccinated are attending school. To this end, the Department attempts to limit the number of communications with respect to existing requirements. ACIP issues recommendations three times a year and adopting ACIP recommendations wholesale would require schools and school nurses to review children for the appropriate vaccine requirements at least three times each year to ensure compliance with recommended changes.
Adopting ACIP's recommendations, without being able to review and affirmatively accept each one, with whatever modifications deemed necessary, would inhibit the flexibility needed by the Department to apply its and the Board's expertise to the question of what immunizations are appropriate as a condition of school attendance. This requires a balancing of the importance of immunization to children in this Commonwealth in preventing morbidity and mortality, versus the burden the requirements would place upon schools, parents and the community.
In fact, the General Assembly has recognized the Department and the Board as authoritative on the issue of immunizations. In section 16(a)(6) and (b) of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.16(a)(6) and (b)), section 2111(c.1) of The Administrative Code of 1929 (71 P.S. § 541(c.1)) and section 1303(a) of the Public School Code of 1949 (24 P.S. § 13-1303a(a)), the General Assembly authorizes the Department, with the Board and without reference to ACIP, to create a list of diseases against which children must be immunized. To cede this authority to create a list of diseases to a Federal advisory committee that has no rulemaking authority or responsibility, and whose recommendations are not subject to a rigorous rulemaking process prior to issuance, is not in accord with the General Assembly's direction to the Department. It is the Department's responsibility, with the approval of the Board and the Commonwealth's regulatory review bodies, including the General Assembly, to determine when and how to add required immunizations to the list.
The Department may review standards from groups with expertise in the matters the Department is seeking to regulate and may consult with those groups as well. The Department has done just that, and continues to do, in many areas falling under its purview. When the General Assembly delegates a responsibility to the Department the final execution of that responsibility rests with the Department under the law. Therefore, the Department may review and approve standards recommended by independent entities, but cannot adopt future unspecified and unknown standards and guidelines.
Then, too, there is a question as to whether it is beneficial to allow some time to pass before accepting an ACIP recommendation as a mandate for school attendance. There may be problems with a vaccine that ACIP has not anticipated. The Department notes that, although the vaccine against the rotavirus was not recommended by ACIP for the age group in question here, within 4 months of ACIP's recommendation regarding that immunization, problems arose and children suffered severe injury and death from twisting of the bowel, attributable to the vaccine. If this were to occur following the adoption of an immunization mandate for school attendance, the public's trust in State government to properly protect them could be irreparably damaged.
The Department understands the concern that the regulatory process lags behind current thinking of the scientific community. New vaccinations continue to be developed and recommendations of knowledgeable bodies change from day to day. What remains a constant is the Department's commitment to protect the health and safety of the children of this Commonwealth by ensuring that it exercises its discretion and expertise to review recommendations and only require the most appropriate immunizations for school attendance in this Commonwealth. The fact that this may take some time only means that these vaccinations are not required for a child's attendance at school immediately upon their recommendation by ACIP. It does not prevent a physician from recommending and offering the vaccination to patients when the recommendations are issued. The Department would rather be cautious in the exercise of its discretion than place additional burdens on the citizens of this Commonwealth by relying too much on outside groups and abdicating its responsibilities to take the most efficient and practical means necessary to prevent and control the spread of disease.
One commentator stated that she felt school nurses had not been consulted as to what was best practice in a school setting.
The Department disagrees with this comment. The Department has always been aware of the need for comment by school nurses and, in this case, specifically sent notice by e-mail of the proposed rulemaking to school nurses to solicit their comments. The Department received multiple comments from school nurses.
PACIC stated that the Department did not solicit input from the public in a manner that would allow the most affected parties, parents of school-aged children in this Commonwealth, to participate and comment. PACIC stated that publishing a proposed rulemaking in the Pennsylvania Bulletin is insufficient advertising to reach the public. The commentator stated that parents will be affected but have not been properly involved in the process as the law and regulations suggest they should. The commentator stated that the Department technically followed the regulatory procedure, but should have advertised more broadly to parents as to how they could comment.
As the commentator noted, the Department complied with the requirements of section 5(b) of the Regulatory Review Act (71 P.S. § 745.5(b)), regarding the solicitation of public comment. The Department also advertised and held a public meeting of the Board on November 4, 2015, which is required to approve the list of immunizations. See 45 Pa.B. 6332 (October 24, 2015). See also section 1303(a) of the Public School Code of 1949, section 2111(c.1) of The Administrative Code of 1929 and section 16(a)(6) of the Disease Prevention and Control Law of 1955.
The Department notes that the State Board of Education held public meetings at which its proposed rulemaking regarding nonimmunized children, published at 46 Pa.B. 1806 (April 9, 2016), was discussed. The proposed rulemaking published at 46 Pa.B. 1806 proposed to amend 22 Pa. Code Chapter 11 (relating to student attendance). Opportunities for comment on that proposed rulemaking were provided during meetings of the committee and the Council of Basic Education on January 13, 2016, and the meeting of the State Board of Education on January 14, 2016.
The Department provided information on the proposed rulemaking to school nurses. Finally, the Department notes that although PACIC stated that parents were not involved as they should have been, the Department received nearly 300 letters of comment, many of which were from interested parents, grandparents and other interested persons.
One commentator raised a concern that there are so many students whose parents sign waivers that the actual impact of the final-form rulemaking could be very minimal. The commentator's student population includes a large number of students with autism and special needs, and a large number of underimmunized students.
The Department disagrees with the commentator. The Department believes that its data shows that the number of students obtaining medical and religious exemptions is nominal in general and does not greatly impact the number of overall students not receiving immunizations. The number of children in the 2014-2015 school year, with 4,450 schools reporting, follows. The number of children with medical exemptions in kindergarten was 462 (0.32%) and in 7th grade was 799 (0.54%). The number of children with religious/philosophical exemptions in kindergarten was 2,536 (1.76%) and in 7th grade was 4,010 (2.69%). The number of children admitted provisionally in kindergarten was 13,890 (9.66%) and in 7th grade was 25,265 (16.92%).
For the 2015-2016 school year, with 3,908 schools reporting, the data showed the following.1 The number of children enrolled with medical exemptions in kindergarten was 795 (0.4%) and in 7th grade was 1,274 (0.5%). The number of children with religious/philosophical exemptions in kindergarten was 4,181 (1.8%) and in 7th grade was 6,580 (2.3%). The number of children admitted provisionally in kindergarten was 6,792 (5.1%) and in 7th grade was 14,383 (10%).
See School Immunization System, School Immunization Summary both Public and Private Schools, School Year: 2014-2015 (School Immunization Summary 2014-2015), http://www.health.pa.gov/My%20Health/Immunizations/schoolimmunizationrates/Documents/2014_15_SILR.pdf, and School Immunization Law Report System, School Immunization Summary both Public and Private Schools, School Year: 2015-2016 (School Immunization Summary 2015-2016), http://www.health.pa.gov/My%20Health/Immunizations/schoolimmunizationrates/Documents/2015_16_SILR.pdf.
The Department believes that the change in the way children are provisionally admitted to school will reduce the potential for disease at those periods during the school year in which children are underimmunized. There is always the potential for there to be areas with a large percentage of underimmunized children. The Department hopes that education and outreach to health care practitioners as well as to parents and guardians can increase immunization rates school-by-school.
PACIC stated that the Department only provided data regarding the provisional period and did not provide data regarding its reasoning to increase the required number of vaccines. PACIC stated that this was a proposal to force a medical procedure on every student in this Commonwealth, and this is a very serious undertaking and must be considered with the utmost scrutiny. PACIC stated that every aspect of the proposed rulemaking must be supported by data and the Department was lacking in its answer to the questions posed by IRRC. PACIC asked that oversight personnel comb through these comments and consider the seriousness of the matter. PACIC stated that this final-form rulemaking will have serious impacts on the majority of families in this Commonwealth as well as the Commonwealth.
The Department disagrees with the commentator's statement that this final-form rulemaking is an attempt to force a medical procedure on every student in this Commonwealth. A vaccine is not a medical procedure. The Department understands that many commentators believe that the decision whether to vaccinate their children should be made by parents, guardians and grandparents alone, and that immunizations should not be mandated. The Department is charged with protecting the health and safety of the citizens of this Commonwealth, and with choosing the most efficient and effective way of doing so. See section 2102(a) of The Administrative Code of 1929 (71 P.S. § 532(a)). After reviewing the comments to the proposed rulemaking, the Department stands firm in its belief that the benefits of requiring certain vaccinations for school entry and attendance outweigh the potential risks raised by commentators. Therefore, the Department did not make changes regarding this topic. The Department addresses the request that it supply data for the additional dose of meningococcal vaccine it is requiring in its responses to that specific section. The Department also supplies additional information regarding the pertussis component of the vaccination in response to comments on that section.
One commentator stated that the proposed amendments would not improve the situation in schools, but changes like requiring a fourth polio dose, a second meningitis dose and a medical certificate with a change in review from 60 days to 30 days will simply create more paperwork for the certified school nurses.
The Department acknowledges the amount of good work school nurses do and will continue to do in the course of changes to the immunization requirements. This final-form rulemaking is intended to continue to keep children safe in the face of emerging and re-emerging diseases, which requires revisions like adding an additional meningitis dose. The Department notes that former § 23.83(b)(3), final-form § 28.83(b)(2), regarding polio stated that three or more doses were required. As amended in this final-form rulemaking, § 28.83(b)(2) specifies four doses to clarify the regulation. The Department expects that school nurses, in carrying out their responsibilities to ensure the safety of students, are continually reviewing vaccination records and ensuring that children are up to date. The Department is hopeful that with continuing education and the work of dedicated school nurses, the situation in schools regarding immunization levels has improved and will continue to improve.
One commentator commented on the following sentence in the preamble to the proposed rulemaking:Parents believe that they no longer need fear, as they did in the past, that a child will be blinded, seriously disabled or killed by measles, polio, diphtheria, pertussis, tetanus, hepatitis B or chickenpox since, up to the present time, these diseases do not occur with the frequency that they did in the past.
The commentator stated that in the past families were not as transient as they are now, and that family doctors did not change with the frequency that now may occur. The commentator stated that they did not have to get their medical records to go from one place to another, risking their loss or improper transcription.
The Department does not disagree with the commentator. The Department's only intention in making this particular statement in the preamble was to note that it believed this was a potential cause for the vaccine rates being seen by the Department. Other commentators have seen the same trend. See Bruesewitz v. Wyeth, LLC (Bruesewitz), 562 U.S. 223, 226 (2011). (''But in the 1970's and 1980's vaccines became, one might say, victims of their own success. They had been so effective in preventing infectious diseases that the public became much less alarmed at the threat of those diseases.'')
Comments regarding cost and paperwork estimate and affected persons sections of the preamble and Regulatory Analysis Form to the proposed rulemaking
One commentator stated that the fact that parents would need proof of a medical certificate, or would have to obtain titers to prove an immunization, would result in substantial cost to the parents, and that the Department had not adequately addressed this issue under the cost and paperwork estimate section of the preamble to the proposed rulemaking. The commentator stated that most titers would not be covered by insurance because it is cheaper to revaccinate if in doubt, and titers are very expensive. The commentator also raised the question of additional paperwork and took issue with the Department's statement in the preamble to the proposed rulemaking that the general public would not have additional paperwork, since parents are the general public.
The Department acknowledged the additional cost, time and paperwork to parents of obtaining a history of immunity from a physician, CRNP or PA in the preamble to the proposed rulemaking. Parents are considered part of the regulated community and are addressed in the regulated community section of the Regulatory Analysis Form (RAF) for the proposed rulemaking, and not in the general public section. After reviewing comments regarding paperwork and cost issues of changing the history of immunity language relating to varicella, including the potential costs of obtaining a blood test to prove immunity, the Department revised the regulation. Further responses to individual comments regarding final-form § 23.83(b)(5)(ii)(B), regarding varicella (chickenpox), are addressed as follows in this preamble. Further costs regarding obtaining a medical certificate are discussed with comments regarding § 23.85(e)(1)(ii) and (iii) (relating to responsibilities of schools and school administrators).
One commentator raised a question regarding the following statement in the affected persons section of the preamble to the proposed rulemaking:The effects of time and funds spent should be outweighed by the benefits to children and their parents, however. Because requiring these immunizations or a more accurate proof of immunity would protect children from contracting measles, polio, diphtheria, pertussis, meningitis, chickenpox and mumps, and other childhood diseases, their parents or guardians would not have to miss work, worry or pay medical bills related to these diseases. Physicians and health care providers would not have to treat sick children. Department staff would not need to become involved in the prevention of outbreaks of vaccine-preventable diseases as they do now. Children and school staff members who are unable to be vaccinated would be protected as well.
The commentator asked what the actual data shows for this Commonwealth and Nationally. In the commentator's high school, there have been no outbreaks in the past decade. The commentator stated that they have had to participate in two pertussis investigations and a chickenpox investigation, with no student contracting the diseases. The students were in contact with students from 13 other school districts on a daily basis.
The Department disagrees with the commentator. While the commentator stated that her school district had no confirmed a case or outbreak, the school district was still involved in case investigations, all involving time and money invested in contact tracing and immunization of those at risk and all stemming from at least one case with the disease which sparked the investigation. These investigations could potentially result in the exclusion of susceptible students and adults, that is, children and adults without immunizations or evidence of immunity. In the case of a measles outbreak, exclusion may last for as long as 14 days after the appearance of the last case of measles. A disruption, for both parents and the child, even as a potential rather than an actuality, far outweighs cost concerns.
Several commentators, including PACIC, stated that the specific costs in sections 19 and 20 of the RAF for the proposed rulemaking were insufficient to support the rulemaking. The commentators took issue with the Department's reference to the costs of the California measles outbreak and stated that these costs seemed excessive. One commentator requested costs for outbreaks in this Commonwealth, which the commentator believed were much lower. Commentators, including PACIC, demanded more reliable data and a total dollar cost to the Commonwealth before further action could be taken.
Several commentators, including PACIC, stated that the Department should address the cost to the Commonwealth and the cost to families of adverse effects from vaccines. PACIC noted that these adverse reactions can include Guillain-Barre syndrome (GBS), encephalopathy and paralysis, all of which require a lifetime of care at high cost to both the family and the state.
PACIC commented that the cost of a pertussis outbreak, according to a CDC study, is approximately $2,172 per case. PACIC stated that in 2014 there were 813 reported cases of pertussis in this Commonwealth, and that approximately 50% of those were in school-aged individuals. PACIC stated that the total cost based on these number is $882,918.
PACIC stated that the Department did not sufficiently describe the cost to each party and did not do due diligence by providing any actual data. PACIC stated that this was an important question that needed to be addressed in detail, with numbers as to the financial and economic impact of this, with copays, lost work hours, lab fees, more reporting procedures and personnel hours. PACIC stated that this would easily total several million dollars, which warrants further examination.
One commentator stated that the Department claimed no costs but many benefits of blanket vaccination. The commentator stated that the Department said there were benefits of sparing children the disease, but no discussion of the costs of side effects. The commentator stated that every vaccine comes with extensive warnings of serious side effects including death, and vaccine manufacturers paid out $3 billion, so it is clear there are costs. The commentator stated that there is no discussion of the effectiveness of needed levels of compliance to meet the ''mysterious'' goals of the Department. The commentator asked how many deaths in the United States will balance out the 18 reported disease deaths. The commentator asked how many more cases this Commonwealth had than more highly vaccinated nearby states. If there is no significant difference, the commentator asked why is the Department pushing so hard to force vaccinations. The commentator asked for a real cost benefit analysis instead of ''skewed propaganda.''
IRRC also noted that many commentators raised questions with regard to the Department's answers to the RAF, including sections 17, 18 and 19, stating that costs will run into millions of dollars. IRRC commented that many commentators questioned the applicability of insurance to vaccinations and noted their possible expense. IRRC also stated that commentators have complained that the Department has significantly understated the increased administrative and paperwork burden to school districts. IRRC requests specific cost estimates regarding the impact of the final-form rulemaking on the regulated community.
The Department is aware that some commentators, including IRRC, raised issues regarding insurance and cost, and the issue of when physicians choose to give immunizations. The Department responded to those questions as follows.
The Department disagrees with the comments regarding cost, and has not revised this final-form rulemaking regarding this topic. The Department is not implementing an entirely new school immunization requirement and reporting system. In this final-form rulemaking, the Department reduced the provisional period, which already existed in some form, added a vaccine requirement for entry into the 12th grade and, by adding pertussis to the list of diseases against which a child shall be vaccinated for school entry and attendance, clarified that the ACIP-recommended vaccine for the diphtheria and tetanus requirement is a vaccine that includes a pertussis component, DTaP, unless pertussis is contraindicated for that child. Although the diphtheria-tetanus toxoid vaccine (DT) is available, there are no single antigen diphtheria, single antigen tetanus or single antigen pertussis vaccines available in the United States.
In determining a cost/benefit of adding vaccine, the Department looked at recommendations by ACIP, including ACIP's own cost/benefit analysis, the fact the vaccine was licensed by the United States Food and Drug Administration (FDA), which reviews safety trials before licensing vaccines, and the costs of outbreaks and disease on students, their families and the Commonwealth. The Department did provide cost data from a recent measles outbreak in California and also provided data regarding cases of that disease in this Commonwealth. While it has not done a study on costs of outbreaks in this Commonwealth, the Department believes the costs of outbreaks in other states, including California, should be sufficient to provide information on what the cost of a vaccine-preventable disease in this Commonwealth could be. The claim that actual costs in this Commonwealth might be different is correct, depending upon the relative dollar amounts for the costs that go into an outbreak response. However, the types of costs are the same, because the methodologies used for disease control are the same. These costs are discussed generally as follows and discussed regarding MCV separately.
With respect to the cost of adverse events regarding vaccines, and the cost effectiveness of vaccines, the Department disagrees with the commentators. At least 1 study suggests that childhood vaccination will prevent an estimated 322 million illnesses, 21 million hospitalizations and 732,000 deaths over the lifetimes of children born between 1994 and 2013. Whitney, MD, C. G., Zhou, PhD, F., Singleton, PhD, J. and Schuchat, MD, A. (2014), ''Benefits from Immunization During the Vaccines for Children Program Era—United States, 1994—2013'' (Benefits from Immunization), Morbidity and Mortality Weekly Report (MMWR), 63(16), 352—355, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6316a4.htm. The ''Benefits from Immunization'' study concluded that vaccination would potentially avert $402 billion in direct costs and $1.5 trillion in societal costs because of illnesses prevented in birth cohorts between 1994—2013.2 The study found routine childhood vaccination to have created $107 billion in direct costs and $121 billion in societal costs. After accounting for these costs, this study found the net present values, or net savings from payers' and societal perspectives, to be $295 billion and $1.38 trillion, respectively. While no one has undertaken a specific analysis of Pennsylvania data for these studies, data from this Commonwealth figured into this research.
With respect to the data provided by PACIC regarding costs of a pertussis outbreak, the Department notes that this is not Pennsylvania cost data, but is data from a school-based pertussis outbreak over 3 months in 2008 in Omaha, NE. ''Local Health Department Costs Associated with Response to a School-Based Pertussis Outbreak—Omaha, Nebraska, September—November 2008'' (Omaha Study), MMWR, 60(1) (2011), 5—9, retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a2.htm. The ''Omaha Study'' found that the cost per case was indeed $2,171 and that cost was attributable to the local health department, approximately 1% of the local health department's annual budget, which would affect taxpayers. The ''Omaha Study'' stated that:1) staff members reported 1,032 person-hours spent responding to the outbreak, and 2) the total cost of outbreak response, including overhead, labor, travel, and other costs, was $52,131 (measured in 2008 U.S. dollars). The majority of costs (59%) occurred during an intensive 10-day period, when most of the contact tracing and prophylaxis recommendations were made.
The outbreak took up a great deal of staff time according to the ''Omaha Study,'' which found that each case of pertussis required nearly 42 regular person-hours and approximately 1 hour of overtime. The time spent investigating a pertussis case included tracing of all close contacts and each pertussis case led to an average of 21 telephone calls and chemoprophylaxis recommendations for 6 close contacts. The health department did not pay for antibiotics or laboratory testing, which presumably was borne by the individuals through insurance or otherwise. According to the ''Omaha Study,'' ''[o]f the total cost, the largest components were investigations (37.2%) and decisions and implementation (22.9%). Resource use was most intensive during the outbreak period for all divisions [of the health department involved] Epidemiology (156% of budgeted hours), Administration (46%), and Media Relations (41%).'' The Epidemiology Division had a resource use of 156%, reflecting overtime and compensation hours worked during the outbreak period. In total, staff members reported 28 hours of overtime with the largest component of overtime allocated to investigation-related activities.
In reviewing the findings, an editorial note to the ''Omaha Study'' stated that they were subject to at least three limitations:First, this report focused on the direct public cost incurred by a local health department in response to a pertussis outbreak. The private costs of pertussis, including those costs borne by patients, persons recommended chemoprophylaxis, health-care providers, or institutions, were not analyzed in this study. However, private costs of pertussis are well studied elsewhere and can be substantial (8,9). Second, although this report measured the total delay in projects resulting from the outbreak, it did not measure the type or number of projects delayed. Future cost analyses also should measure the ''opportunity cost'' of outbreaks in more detail. Finally, although these data offer a picture of public health cost when responding to an outbreak, they only reflect the resource use of one health department and might differ for other health departments. For example, health departments that pay for laboratory testing and antibiotic courses for patients would incur additional costs.
In short, the costs to the government, including taxpayers, and to the health system of any outbreak response can be significant.
The Commonwealth would respond to an outbreak in the same way that Nebraska did. Once a case is reported, the individual, or the parents or guardians of a child, is interviewed and close contacts are identified. Those individuals are contacted and interviewed to find more contacts. Depending on CDC recommendations, different drug regimens may be prescribed. Depending on the disease, children and adults who are presumed susceptible or are unvaccinated, those who cannot prove a history of immunity depending on the disease in question, or those showing symptoms may be excluded from school until they are treated or until the exclusionary period ends. That period differs for different diseases. For example, with measles, the exclusionary period for susceptible children is 14 days from the date of the last case. The more cases that are reported, the longer the exclusionary period.
In the Nebraska case, chemoprophylaxis was recommended for those persons who had direct face-to-face contact with an ill person, who shared a confined space with an ill person for more than 1 hour, or who had direct contact with respiratory, nasal or oral sections from a symptomatic person. The health department in that case recommended exclusion from school of persons with a cough until they were evaluated by a doctor and then, when more cases were reported, recommended students with a cough be excluded until evaluated by a physician and either treated or determined to have pertussis.
The Department has not looked at cost in a school-based outbreak of pertussis, but it has looked at cost in a pertussis outbreak in a health care facility. In that circumstance, it took upwards of 2 weeks to diagnose the case, and by that time there were a number of symptomatic health care workers and many exposed contacts. The costs to the health care facility approximated $74,870, including laboratory tests, antibiotic treatment and prophylaxis, and incidental costs (labor and postage). There were also indirect costs to the health care facility of $11,200, including furloughs of workers. The health care workers themselves ended up with direct costs of $4,679 in outpatient visits, hospitalization and medications, and indirect costs of $1,730 in time lost from work.
Similar types of costs would attend an outbreak in school, although potentially the costs would be spread throughout the affected community differently. Presumably a school would not pay for laboratory testing or treatment as the hospital did, but teachers and students would have copayments, and potential treatment and prophylaxis costs if uninsured or underinsured. If required to exclude children and teachers, the school would bear that cost, including loss of work, and potentially loss of educational time. The school would further bear the cost of hiring substitute teachers to the extent teachers were impacted.
In addition, the Department knows of a circumstance that would certainly involve cost in a situation with a potential disease outbreak involving health care workers. In that situation, an unvaccinated child was seen at a provider with a potentially highly infectious disease. The suspect case was reported to the Department. The following day specimens were taken and sent to the CDC for testing. The 3rd day press releases regarding exposure were issued (the child had been in various places during the period of communicability) and immunization clinics were set up. Immunization clinics continued on the 4th day. The 4th day additional titers from unvaccinated health care personnel or those without immunization records were drawn for testing. On the 5th day, the provider office and building where the child had been were closed. The results from the CDC came back negative on the 6th day, and the office reopened 1 week later.
During this potential outbreak, 186 contacts were followed by the Department, 93 of them were quarantined and 119 were immunized. This involved intense coordination with multiple practices located in the building, to talk to staff and to notify patients who could have been at risk. In addition, multiple employees of the practice who did not have titers drawn or records of immunization could have been quarantined until either titers were drawn, or the situation resolved itself. There was a disruption in the lives of patients and employees, loss of revenue to the practices and loss of work by the employees.
The CDC also looked at the economic burden of 16 measles outbreaks on public health departments in 2011. In that study, the estimated number of contacts was 8,936 to 17,450 persons. The estimated number of personnel hours ranged from 42,645 to 83,133. The estimated economic burden ranged from $2.7 million dollars to $5.3 million dollars.
The Department also did a literature review regarding the costs of measles outbreaks and found the following: Iowa, 2004, $142,452; California, 2008, $176,980; Arizona, 2008, $799,136; Kentucky, 2010, $24,569; Utah, 2011, $130,000; and Challam County, Washington, 2015, $200,000. Dayan, G. H., Ortega-Sánchez, I. R., LeBaron, C. W. and Quinlisk, M. P. (2005), ''The Cost of Containing One Case of Measles: The Economic Impact on the Public Health Infrastructure—Iowa, 2004,'' Pediatrics, 116(1) retrieved from http://pediatrics.aappublications.org/content/116/1/e1. Chen, S. Y., et al. (2011), ''Health Care-Associated Measles Outbreak in the United States After an Importation: Challenges and Economic Impact,'' The Journal of Infectious Diseases, 203, 1517—1525, retrieved from http://jid.oxfordjournals.org/content/early/2011/04/25/infdis.jir115.full.pdf+html. Iannelli, MD, V. (2016), ''Costs of a Measles Outbreak: Measles Outbreaks are Expensive to Contain,'' Verywell, retrieved from https://www.verywell.com/costs-of-a-measles-outbreak-2633850.
The Department weighed the potential costs of an outbreak to this Commonwealth to the Department, to the regulated community, including parents, guardians and children, both vaccinated and unvaccinated, to the health care sector and to the wider community against the costs of copayment, the potential for adverse reactions to children from these vaccinations and the costs of those adverse reactions. In the end, the Department believes it is appropriate to require these immunizations. The Department also relied upon ACIP's recommendations, including its cost and benefit analysis, the cost and safety analysis done by the FDA in licensing both MCV and DTaP. Additional cost benefit information regarding MCV, including references to the cost-benefit analysis performed by ACIP, is included in the Department's responses to § 23.83(c)(2). The General Assembly has given the Department the authority to balance these costs and concerns and to then create the list of diseases and conditions against which children must be vaccinated to enter and attend school. The Department has exercised its discretion in this regard in promulgating this final-form rulemaking.
PACIC commented that the Department's response to section 23 of the RAF, which requires an estimate of the fiscal savings and costs associated with implementation and compliance for the regulated community, local government and State government for the current year and 5 subsequent years, did not contain data and that the estimated cost to the State government should read ''at least $1,701,245.''
The Department addresses the question of the cost-effectiveness of meningococcal vaccine in the response to comments on § 23.83(c)(2), and notes that cost-effectiveness studies leading to ACIP's recommendations included adverse events. With respect to PACIC's comment regarding the appropriateness of the information in section 23 of the RAF, regarding to cost to State government, PACIC misunderstands the purpose of this section. To determine State costs of a proposed or final-form rulemaking, the cost to the State government is considered to be cost that must be made up by new State dollars. The Immunization Program is not new and is not funded by State dollars, so there are no costs reflected for State government in section 23 of the RAF. The cost of the Immunization Program, or program expenditures, is reflected in section 23a of the RAF and includes the potential amount for administration of vaccine doses. Section 23a of the RAF showed the budgeted amount for the Immunization Program for that fiscal year and for the past 5 years. In the RAF for this final-form rulemaking, the Department shows no new State dollars in the cost because there are no new State dollars funding the Federally-funded Immunization Program.
Comments regarding the VFC Program
PACIC stated that the box allocated for the economic cost of the regulated population should include copayments for at least 868,823 students not eligible for the VFC Program, as students entering 12th grade have no other requirement for a doctor's visit (such as a physical or other examination). PACIC stated that this will incur an office visit fee estimated at $20. PACIC stated that this totals $17,376,460. PACIC asked how many children are using the VFC Program and requested data and details about the popularity and funding of the VFC Program.
The Department disagrees with the commentator. The number of students cited by PACIC is not the number of children entering 12th grade in any given year, but the number of children in this Commonwealth eligible for the VFC Program in 2014 in all grades. PACIC appears to be arguing that, since children entering the 12th grade have no other reason to be seen by a health care provider, there will be additional copayments that cannot be attributable otherwise than to administration of the vaccine. If this is the case, and the Department notes that children may receive the dose at 16 years of age, which may coincide with other scheduled childhood physicals, the total number of students entering 12th grade in 2014 was 147,040, as the Department pointed out in the RAF for the proposed rulemaking. A study of the VFC Program from 1994 to 2013 suggested that 70% of children obtained their vaccines from private providers, and the cost of administering a vaccine was roughly $29.07 per child (in 2013 dollars). See Appendix: Methods for the cost-benefit analysis in ''Benefits from Immunization.''
The Department noted in the RAF for the proposed rulemaking that in this Commonwealth, approximately 50% of the children are eligible for the VFC Program. However, the Department does not collect utilization data for the VFC Program. For public clinics, the Department noted that the maximum regional charge in this Commonwealth was $23.14 per administration of the dose to a child. Using the study numbers, the total cost of copayments for persons not obtaining their vaccines from the public sector would be roughly $2.9 million dollars, or $29.04 per child. The Department again points to the study done on the net cost savings from childhood vaccines from 1994 to 2013, the fact that ACIP has done a cost-effectiveness study of two doses of the MCV vaccine and recommends that second dose, and the fact that the FDA has licensed the vaccine. Cohn, MD, A. C., et al. (2013), ''Prevention and Control of Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP)'' (Prevention and Control (2013)), MMWR, 62(RR 2), 1—27, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6202a1.htm. The Department finds that the requirement of MCV in the 12th grade is safe and cost effective. The Department also notes that parents and guardians have the option of seeking both medical and religious exemptions.
In response to the commentator's question regarding funding for the VFC Program, the program is funded by Federal dollars. The Pennsylvania VFC Program budget for Fiscal Year 2015-2016 was $77,363,406.70.
Comments regarding whistleblower law suit against Merck
Several commentators mentioned that Merck, which has offices in this Commonwealth, is currently defending its measles, mumps and rubella (MMR) vaccine against Federal antitrust law suits. These commentators noted that employee physicians and scientists claim that data regarding the vaccine's efficacy was falsified, the drug was mislabeled and information was intentionally concealed. They further noted that these factors have implications for the Federally-granted monopoly for the MMR vaccine recommended by the Federal government, and mandated by all states for entry into schools.
Another commentator also raised the Merck lawsuit and asked if this was why children must now get two doses of the MMR vaccine, since the company claims that the 20% of the population will not be properly immunized with just one dose anymore. The commentator asked how pharmaceutical companies can be held accountable for failing products if children's titers are not checked after routine vaccination. The commentator stated that her youngest daughter was tested several years after her first MMR and had no immunity to rubella afterwards. The commentator asked how likely it was that she was just one of the supposed 20% that will not respond and will need a second booster. The commentator asked whether the same phenomenon was occurring with the combination diphtheria, pertussis and tetanus vaccine, where it is being proposed that 12th graders receive a third dose of this combination vaccine. The commentator asked how many times adverse reactions and permanent injury in children should be risked. The commentator questioned who was actually checking the children to see if they possess the titers to these diseases in their blood stream. She asked whether it was safe to give all these vaccines at once. The commentator asked that the Department require titers to be routinely tested in children following vaccination, for example. The commentator stated that it was her hope that children can one day be vaccinated safely for their health and not for a drug company to prosper.
Two commentators stated that Merck's MMR vaccine is the subject of a separate whistleblower claim and that the data linking the vaccine to autism was suppressed by the CDC. One commentator stated that this is especially significant since this tainted study is the one that was relied upon by the National Institutes of Medicine when it investigated and concluded that there was no autism link.
The Department's requirement that a child have immunity to MMR is not the subject of this final-form rulemaking. The Department did not require that all children have the MMR vaccine because Merck has offices in this Commonwealth. The Department is not requiring all children receive titers to determine immunity; for measles and mumps immunity, children may show a physician, PA or CRNP history, or a blood test result to prove immunity if they cannot show a vaccination. The Department proposed to require the same level of history of immunity for chickenpox. However, the Department decided to withdraw that requirement because of the cost of the blood test. The same concern regarding requiring a titer to show measles immunity would apply here. There would be a concern regarding coverage by insurance for the test in the absence of an actual outbreak. Regarding the commentator's concern about a third dose of MMR in the 12th grade, the regulations do not require this. The Department is requiring a second dose of MCV in the 12th grade. The Department's responses to comments regarding that requirement follow.
The Department believes that combination vaccines are safe. In making that determination, the Department relies upon ACIP, the licensure requirements of the FDA and the credible scientific literature; studies have found no evidence of harm in combination vaccinations.
The Merck whistleblower case involves questions surrounding the efficacy of the mumps vaccination. The Merck case is ongoing. The Department deplores the act of placing children at risk by falsifying data, if that occurred. Commentators' allegations that information connecting the MMR to autism were suppressed by the CDC are addressed as follows.
Relation of vaccines to autism, chronic disease, injuries and illness
Several commentators stated that the autism rate is now 1 in 45 according to a UPI report, while in the 1980s the rate was 1 in 10,000. The commentators stated that the rise in the autism rate correlated with the increased number of vaccines children are required to take. The commentators stated that although it was not the only cause for the rise, it was a cause that needed to be addressed. The commentators stated that there are many stories of mothers taking perfectly healthy children to the pediatrician and after the child is given multiple vaccines at the same time they regress and are never the same. According to the commentators, many mothers know that this was the exact day their child developed autistic behavior. They are told it is coincidental and forced to fight for their rights in Vaccine Court. The commentators stated that the National Vaccine Injury Compensation Program has awarded more than $3.3 billion over the life of the program to families whose children were injured by a vaccine. According to the commentators, there is massive underreporting of adverse vaccine events because many parents do not realize the ensuing illness could be related directly to the vaccine recently received. The commentators asked that if vaccines have been proven safe and effective, why has the ''vaccine industry'' been protected from liability and lawsuits. The commentators asked that if they are ''deemed to be extraordinarily safe'' by a leading proponent of vaccine in the Philadelphia medical community, why are they shielded from lawsuits. According to the commentators, the same doctor stated that he believes that a child's ''immune system could theoretically handle 10,000 vaccines at one time.'' The commentators asked whether ''any professional in their right mind could believe such a statement.''
The Department has not revised this final-form rulemaking in response to these comments. The Department addresses the issue of liability of vaccine manufacturers as follows in this preamble. In response to the question asked regarding why there is a need for the Vaccine Court if vaccines are safe, the Department notes, as it has always stated, no vaccine is either 100% effective or 100% safe. To determine whether or not a vaccine should be approved or given, the question that must be weighed is whether it is safer to take the vaccine or risk the disease. The Department maintains that for those children without contraindications to vaccines, receiving the vaccines recommended by ACIP and included in the Department's list of immunizations that are required prior to school entry and for school attendance, a child is safer receiving the vaccine than not doing so.
One commentator stated that there was no merit in the contention that unvaccinated persons posed a health threat to others. The commentator stated that the literature shows that unvaccinated persons are generally healthier and have good immune systems that are not assaulted by numerous toxins found in vaccines. The commentator stated that prior to the massive number of vaccines being given to children, there were not as many cases of the diseases of asthma, atopy, allergy (often life threatening), autoimmunity, autism, learning disorders, communication disorders, developmental disorders, intellectual disability, attention deficit disorder, disruptive behavior disorder, tics, Tourette's syndrome, seizures, febrile seizures and epilepsy, and diabetes. According to the commentator, these events ''scream for a response.'' According to the commentator, the Department should not be adding to the misery of parents and children by increasing the mandate for more vaccinations.
One commentator stated that as a grandparent, she and her daughter have done research so that they could make an informed decision on vaccinations. Based on their findings and their beliefs, they have opted not to vaccinate their children and stated that no one can be more concerned for the safety and welfare of their children than they are. The commentator asked that the Department help protect their parental rights. The commentator stated that there are proven concerns regarding the safety and efficacy of vaccines, as recent outbreaks of mumps and measles show. The commentator stated that nonvaccinated children are not a threat to the public at large.
Several commentators stated that known problems with vaccines are rarely acknowledged by public health officials. One commentator noted that chronic conditions in children have skyrocketed in recent decades and according to the CDC one in six children have learning disabilities. The commentator stated that public health officials cannot explain this decline in children's health and why 43% to 54% of all American children suffer with one chronic illness requiring health insurance reimbursement, including 26% of children under 6 years of age at high risk for developmental, social or behavioral delays. Two commentators stated that developmental disabilities among American children have increased by 17%, a fact which is admitted by government officials, and is led by a rise in autism and attention deficit hyperactivity disorder (ADHD).
One commentator also stated that as a physical therapist, she has witnessed the epidemic of autism that plagues the Nation. The commentator stated that since the government deregulated the field of biotechnology in the 1980s, there are no long-term studies measuring the effects of genetically modified organisms (GMO) and adjuvants such as aluminum on human tissues located throughout various places of the body, especially the nervous system. The commentator stated that since GMOs have been introduced, there has been a steady upward trend of autism, various autoimmune diseases, Alzheimer's disease and cancers throughout our population. The commentator stated that the situation is completely out of control, and various health and environmental changes brought about by the biotechnology field need to be examined before more potential harm is done.
The Department disagrees with the commentators. The Department's final-form rulemaking does not involve all vaccines available for children, or even all vaccines on the Department's list of immunizations that are required for school entry and attendance. This final-form rulemaking only deals with the addition of one dose of MCV in the 12th grade and a pertussis dose for attendance. One commentator references GMOs, yet does not point to any specific organism in either of those vaccinations that would be considered a GMO. With regard to aluminum, about which several commentators raised issues, the Department notes that DTaP does include a form of aluminum. It is included in vaccines to enhance the immune system's response to the vaccine. It has been safely used for decades. Brown, MD, FAAP, A. ''Clear Answers and Smart Advice About Your Baby's Shots'' (Clear Answers and Smart Advice), Immunization Action Coalition, item No. P2068 (8/16), retrieved from www.immunize.org/catg.d/p2068.pdf. The National Vaccine Program Office and the World Health Organization have determined that the amount of aluminum in vaccines is safe. If a baby follows the standard immunization schedule, the baby is exposed to about 4—6 milligrams of aluminum at 6 months of age. By comparison, the baby is exposed to 10 milligrams if he is breastfed, 40 milligrams if he is fed cow's milk-based formula or 120 milligrams if he is fed soy formula. A standard antacid tablet contains about 200 milligrams of aluminum. ''Clear Answers and Smart Advice,'' citing Children's Hospital of Philadelphia, Vaccine Education Center, www.vaccine.chop.edu/service/vaccine-education-center/hot-topics/aluminum.html (accessed July 30, 2016).
One commentator stated that vaccines are medical procedures that can cause serious injury and death, and additional information should be provided before mandating that children in this Commonwealth receive more of them to attend school. The commentator asks that the Department and the Department of Education provide annual statistics to IRRC and the public that compare the number of vaccines suggested by ACIP and mandated by the Commonwealth along with the number of children who have autism, learning disabilities and require additional support in school. It would be informative to have the educational costs associated with special education learning support, and the like, over the past 30—40 years. Another commentator asked the Department of Education to provide statistics to evaluate the increase in special education teachers, aides and funding over the last 50 years. The commentator also requested studies that compare the health of vaccinated versus unvaccinated children, which would enable more informed decisions about the overall health of children in this Commonwealth, rather than focusing so single-mindedly on vaccination rates.
One commentator stated that there is much concern over vaccines right now due to the number and type of vaccines that are being given to babies and young children. The commentator stated that more and more information and research is coming out every day and people are starting to become educated on what they are injecting into their children. The commentator asked that the Department slow down changes and additions to the vaccine policy for young children. The commentator stated that responsibility must be taken for the safety of children in this Commonwealth because the vaccine manufacturers do not.
One commentator stated that the three of her children had been affected by vaccinations—one child has ADHD, one child has autism and one child is prone to epilepsy. She stated that she had to do extensive therapies to restore their immune systems.
One commentator stated that her child received vaccinations until he was 8 years of age because by that time he had had several years of pneumonia vaccinations but got sick with pneumonia four times.
One commentator, speaking for himself and his spouse, stated that vaccines were a violation of their religious beliefs. The commentator further stated that there was overwhelming evidence that vaccinations were connected with autism and various other serious health issues. The commentator stated that this was vindicated for his spouse and himself by a personal experience with a relative when the relative was a child because the relative was perfectly normal prior to the vaccine.
The Department disagrees with the commentators and has not revised this final-form rulemaking. The Department is not promulgating a new regulation that would, for the first time, require vaccines for school entry and attendance. The Department is only adding MCV in the 12th grade to the list of required immunizations and is formalizing the requirement of a first dose of pertussis, which, due to the lack of single antigen vaccines for diphtheria and tetanus in the United States, has been in place de facto for some time. The Department discussed the risks versus the benefits of pertussis and MCV vaccines in the sections of this preamble regarding those immunizations and also addressed the safety of combination vaccines in this preamble. The Department notes that the religious exemption is available for persons for whom vaccination is a violation of their religious beliefs.
The Department can and will address cost issues regarding a second dose of MCV and pertussis, but does not have access to and does not see the utility of a set of numbers showing the number of children with autism, learning disabilities and who require additional support in school, and the number of children who have vaccines. The fact that either of the two numbers go up or down, or are large or small, without more, does not prove a theory, show a corollary or provide causation. There is no credible study showing a link between autism and the MMR.
In fact, the Department is not aware of any valid, scientific study that finds that any of the diseases of asthma, atopy, allergy, autoimmunity, autism, learning disorders, communication disorders, developmental disorders, intellectual disability, attention deficit disorder, disruptive behavior disorder, tics, Tourette's syndrome, seizures, febrile seizures and epilepsy, and diabetes are caused by childhood vaccinations. A study by two British doctors published in the British publication The Lancet claiming to have found a link between autism and the MMR vaccine was later retracted by The Lancet following controversy regarding the conduct of the study. Wang, S. S. (February 3, 2010), ''Lancet Retracts Study Tying Vaccine to Autism,'' The Wall Street Journal. Other researchers were unable to replicate the results and eventually there were allegations of fraud against the lead author. ''Clear Answers and Smart Advice''; Offit, MD, P. A. and Bell, MD, L. M. (2003), Vaccines: What You Should Know, New Jersey: Wiley. The lead author eventually lost his medical license to practice in England. See http://briandeer.com/solved/gmc-wakefield-sentence.pdf.
One commentator stated that the Department is using scare tactics to force parents to inject their children with known toxins with no regard to their actual safety. The commentator noted that the United States was the most widely vaccinated country with the highest rate of chronic illness in the world. The commentator stated that more honest research needed to be done on the true effects of the vaccinations being forced on the unsuspecting public.
The Department cannot force parents to inject their children, nor can it forcibly inject children itself. The Department can based on recommendations by ACIP following licensure by the FDA, and based on the advice of its staff of experts, choose to add certain vaccinations to the list for which students are to be vaccinated to attend school. The Department notes that the medical and religious/philosophical exemptions still exist for parents or guardians who wish to avail themselves of them.
One commentator stated that vaccines cannot protect health; only a strong immune system can protect health. The commentator stated that the immune system needs whole foods, clean water, sunshine and fresh air to function at its optimum level. According to the commentator, the immune system is incredibly powerful when it is given what it needs. The commentator stated that vaccines introduce into the body nothing but known toxins, carcinogens and undigested proteins from animal and human tissues on which they are grown. The commentator stated that they are contaminated with other diseases causing viruses and bacteria including retroviruses, tuberculosis, SV40 virus and syphilis. The commentator stated that vaccines stimulate the wrong part of the immune system. Natural infection stimulates the first line of defense, cell-mediated immunity. This is what is needed for long-term immunity and to effectively clear the virus from the body. According to the commentator, a vaccine triggers a humoral response, which is an inflammatory response. Inflammation causes disease, and this response is not desirable and is not the body's natural response to infection. A humoral response cannot effectively eliminate the injected virus or bacteria from the body. The commentator stated that the body's protective barriers are designed to prevent viruses and bacteria from gaining access to the body's vital organs. The commentator stated that the vaccines bypass the protective barriers and put toxins into the muscle which in turn go directly into the bloodstream and then circulate to the body's vital organs. The commentator stated that death rates from diseases in the 1850s and 1950s fell 90% before vaccines were introduced, due to improved sanitation and better nutrition. The commentator stated that to date at least 413 abortions were performed specifically for the development of vaccines. The commentator stated that the already born person is not more valuable than the unborn person. The commentator stated that infectious disease is not epidemic in this country because of public sanitation, but the real epidemic is that one in six children have learning disabilities, autism, asthma and allergies. The commentator stated that true public health cannot be attained when true measures of health are ignored in favor of allopathic medicine. Allopathic medicine offers only toxic drugs or surgery to cover symptoms. The body uses symptoms to cure itself. According to the commentator, health care and science cannot advance positively if only one model of health is forced on society. The commentator asked that the Department research the harmful effects of vaccines before mandating them.
The Department disagrees with the commentator. The Department respects the views of the commentator regarding allopathic medicine and the commentator's wish that more than one health care model be considered. The Department points to the public health achievements of the 20th century, including the near eradication of polio and the eradication of smallpox, both of which were achieved with vaccination programs. The Department takes issue with the statistic quoted by the commentator regarding the decline in disease, and the attribution that a decline was due merely to sanitation. The Department notes that the great polio outbreaks during the century occurred in the 1950s. ''Achievements in Public Health, 1900—1999 Impact of Vaccines Universally Recommended for Children—United States, 1990—1998'' (Achievements in Public Health), MMWR, 48(12) (1999), 243—248, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm. The Department is aware that no vaccine is 100% effective and that in some cases, including with smallpox, immunity has been found to have waned. However, even if immunity has waned, a vaccinated individual still has some protection and is likely to have a less virulent form of the disease.
The Department does not disagree that chronic disease is an issue in the United States, but it does not agree that a link between those diseases and immunizations has been scientifically shown. Instead, the Department agrees with the commentator that good food, fresh water, sunshine and fresh air would go far in lessening incidence of diabetes and obesity and the health problems attendant on these conditions. Better hygiene and sanitation may help prevent the spread of disease but they will not eradicate the germs that cause disease. As long as those organisms still exist, people will continue to get ill. A review of the history of vaccine preventable disease shows that a drop in disease almost always occurs when a vaccine is introduced. If the decline in diseases were due to better hygiene and sanitation, the expectation would be that the number of cases for all diseases would begin to drop at the same time. For example, while the number of polio cases started to decline in 1955, the number of Haemoinfluenza b (Hib) cases began to drop in 2000, corresponding to the introduction of vaccinations for those diseases. See https://www.vaccines.gov/basics/effectiveness/index.html.
As to how vaccines work, vaccines help develop immunity by imitating an infection. Vaccines mimic disease agents, without making the person sick, and stimulate the person's immune system to build up defenses against them.
One commentator asked how long children in the United States would be healthy if they are repeatedly injected with diseases, formaldehyde, mercury, aluminum, polysorbate 80, neomycin, animal DNA and aborted fetal DNA. The commentator asked if chickenpox is being traded for cancer. The commentator stated that there had been an epidemic of childhood cancers, autoimmune disorders and neurological disease including autism, and some studies show the excessive vaccines are the cause. The commentator stated that looking at the time line between the increase in these problems and the increase in vaccines. The commentator stated that the CDC found out in 2001 that the MMR vaccine causes autism, and committed fraud in 2004 to cover up the results. The commentator stated that the MMR given early under 36 months of age most definitely causes autism in many children, particularly African American boys. The CDC cannot be trusted to manage the safety of vaccines.
The Department disagrees with the commentators regarding childhood vaccines and any causal link to autism. In fact, no study has shown that the number of vaccines given to children cause autism. The Department cannot speak to the ''neurological diseases'' referenced, since the statement is not specific. With respect to autism, the only study purporting to show a link between a vaccine and autism was disproven; 10 of the 12 authors withdrew their support from the 1998 study; The Lancet, which published the article, retracted it; and the lead author lost his medical license in Britain in 2010.
With respect to the reference to the CDC ''cover-up'' regarding autism and the MMR vaccine, the Department's review of the information available leads it to disagree with commentators. The allegations are specifically that data suppressed by the CDC proved that the MMR vaccine produces a 340% increased risk of autism in African American boys. The Department notes that the putative CDC whistleblower, Dr. William W. Thompson, released the following statement through his attorneys:I regret that my coauthors and I omitted statistically significant information in our 2004 article published in the journal Pediatrics. The omitted data suggested that African American males who received the MMR vaccine before age 36 months were at increased risk for autism. Decisions were made regarding which findings to report after the data were collected, and I believe that the final study protocol was not followed.I want to be absolutely clear that I believe vaccines have saved and continue to save countless lives. I would never suggest that any parent avoid vaccinating children of any race. Vaccines prevent serious diseases, and the risks associated with their administration are vastly outweighed by their individual and societal benefits.My concern has been the decision to omit relevant findings in a particular study for a particular sub-group for a particular vaccine. There have always been recognized risks for vaccination and I believe it is the responsibility of the CDC to properly convey the risks associated with receipt of those vaccines.I have had many discussions with Dr. Brian Hooker over the last 10 months regarding studies the CDC has carried out regarding vaccines and neuro-developmental outcomes including autism spectrum disorders. I share his belief that CDC decision-making and analyses should be transparent. I was not, however, aware that he was recording any of our conversations, nor was I given any choice regarding whether my name would be made public or my voice would be put on the Internet.
Retrieved from http://morganverkamp.com/statement-of-william-w-thompson-ph-d-regarding-the-2004-article-examining-the-possibility-of-a-relationship-between-mmr-vaccine-and-autism/.
Dr. Brian Hooker, mentioned in Dr. William W. Thompson's statement, published an article in Translational Neurodegeneration concluding that ''African American males receiving the MMR vaccine prior to 24 months of age or 36 months of age are more likely to receive an autism diagnosis.'' The article was removed from public domain due to issues of competing interests on the part of the author which compromised the peer review process. Further, post-publication peer review raised concerns about the validity of the methods and statistical analysis. The retraction note is posted at http://translationalneurodegeneration.biomedcentral.com/articles/10.1186/2047-9158-3-22.
The CDC published a statement regarding the original article and the data used in the study is available for analysis by others. CDC (2015), ''CDC Statement Regarding 2004 Pediatrics Article, 'Age at First Measles-Mumps-Rubella Vaccination in Children with Autism and School-matched Control Subjects: A Population-Based Study in Metropolitan Atlanta,''' retrieved from http://www.cdc.gov/vaccinesafety/Concerns/Autism/cdc2004pediatrics.html. As the CDC noted in this statement ''[a]dditional studies and a more recent rigorous review by the Institute of Medicine have found that MMR vaccine does not increase the risk of autism.''
The Department addresses comments regarding the following topics in this preamble: vaccine additives; multiple vaccines; combination vaccines; and vaccine manufacturer liability.
One commentator stated that she read that the CDC has covered up actual harm from the MMR vaccine. She stated that she believes the vaccine industry and the CDC collude to keep information from the public regarding the safety of vaccines. The commentator stated that the public has long been led to believe that vaccines are safe and not a choice. The commentator stated that she has read many accounts of children and adults suffering harm and dying from vaccines where the chance of getting the disease or dying from it was much lower. The commentator stated that persons making decisions about mandatory vaccinations should consider the facts from someone other than the vaccine manufacturers, whose only concern is ''keeping the cash flowing.'' In addition, the commentator stated that she was gravely concerned about the direction the country was moving where parents were losing their right to make informed decisions. The commentator stated that for too long the vaccine industry has been allowed to dictate an ever increasing schedule. The commentator stated that just because vaccines have always been considered safe, safety should not be assumed, particularly in light of the fact that 1 in 45 children is autistic. The commentator stated that the vaccine industry has no testing and vaccines contain many requirements that do more harm than good.
Although the Department is not in a position to change the commentator's view of the pharmaceutical industry or the CDC, the Department notes that no vaccine is licensed for use by the FDA without going through clinical trials. In certain instances, a compassionate use exception may be granted, or the approval process accelerated, for example, as with the Ebola vaccine when the FDA in 2016 granted ''breakthrough therapy'' designation to the investigational vaccine for the Ebola Zaire virus. See Eslava-Kim, PharmD, L. (2016), ''Investigational Ebola Vaccine Granted Breakthrough Therapy Status,'' MPR, retrieved from http://www.empr.com/drugs-in-the-pipeline/investigational-ebola-vaccine-granted-breakthrough-therapy-status/article/511504/. The Department is comfortable with the recommendations of ACIP regarding MCV and pertussis. The Department addresses issues regarding autism in this preamble.
Several commentators made the comment that unvaccinated children are healthier than vaccinated children. One commentator stated that many doctors who take care of both unvaccinated children and vaccinated children report the unvaccinated children are much healthier than vaccinated children. The commentator stated that unvaccinated children have fewer earaches, sinus infections, stomach problems and allergies. The commentator stated that unvaccinated children have healthier immune systems because they have not been injected with an overload of diseases their whole lives which overload and compromise the immune system. When they get sick, they are able to fight off infections. The unvaccinated children are not the threat to schools. Vaccinated children are getting sick with the diseases they were vaccinated for and proving that the vaccines do not provide the ''immunity,'' so how are vaccines immunizations. The commentator stated that this is a good reason for a philosophical exemption.
One commentator stated that the proposed amendments were highly problematic, and that there were several issues of concern which must be noted and thoroughly discussed. The commentator stated that the Department was assuming incorrectly that immunocompromised individuals are unable to be vaccinated, and that all vaccines prevent vaccinated individuals from transmitting disease to the immunocom-promised. The commentator stated that several vaccines contain live virus, and when given to others can shed and potentially infect immunocompromised individuals for up to 3 weeks. Requiring children to receive live virus vaccines to protect the immunocompromised may possibly backfire by spreading the very diseases they are meant to protect against.
With respect to the comment that unvaccinated children are healthier than vaccinated children, the Department respectfully suggests that no support exists for that statement. The Department disagrees that vaccinations suppress a child's natural immune system. Children are exposed to many foreign antigens every day. Eating food introduces new bacteria into the body and numerous bacteria live in the mouth and nose, exposing the immune system to still more antigens. An upper respiratory viral infection exposes a child to 4 to 10 antigens and a case of strep throat exposes a child to 25 to 50 antigens. According to Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality, ''[i]n the face of these normal events, it seems unlikely that the number of separate antigens contained in childhood vaccines. . .would represent an appreciable added burden on the immune system that would be immunosuppressive.'' Institute of Medicine (1994), Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality (Adverse Events Associated with Childhood Vaccines), Washington, DC: National Academy Press, retrieved from http://www.nap.edu/read/2138/chapter/5?term=%22normal+events%22#62. See also Vaccines: What You Should Know, p. 100. Available scientific data show that simultaneous vaccination with multiple vaccines has no adverse effect on the normal childhood immune system. In fact, the CDC states:Simultaneous administration (that is, administration on the same day) of the most widely used live and inactivated vaccines does not result in decreased antibody responses or increased rates of adverse reaction. Simultaneous administration of all vaccines for which a child is eligible is very important in childhood vaccination programs because it increases the probability that a child will be fully immunized by the appropriate age.
CDC (2015), Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book), Washington, DC: Public Health Foundation, retrieved from http://www.cdc.gov/vaccines/pubs/pinkbook/index.html.
The Department further disagrees with the proposition that vaccinated children are getting sick with the diseases against which they were vaccinated. In a study of the risk of vaccine-preventable diseases among children 3 to 18 years of age in Colorado who have philosophical and religious exemptions, researchers determined that exemptors were 22.2 times more likely to acquire measles and 5.9 times more likely to acquire pertussis. Feikin, MD, MSPH, D. R., et al. (2000), ''Individual and Community Risks of Measles and Pertussis Associated with Personal Exemptions to Immunization,'' JAMA, 284(24), 3145—3150, retrieved from http://jama.jamanetwork.com/article.aspx?articleid=193407. See also Glanz, J. M., et al. (2009), ''Parental Refusal of Pertussis Vaccination is Associated with an Increased Risk of Pertussis Infection in Children'' (Parental Refusal of Pertussis Vaccination), Pediatrics, 123(6). The commentators did not cite a study for their proposition or offer other evidence other than an anecdotal statement that many doctors believe this. The Department can point to doctors that disbelieve the proposition. Live attenuated vaccinations contain live viruses that are a weakened strain. See Pink Book, p. 5, and Vaccines: What You Should Know, p. 100. These vaccines usually do not cause disease as may occur with the ''wild form'' of the organism. In fact, the Pink Book, p. 21, states that MMR and varicella, both live attenuated vaccines, may be given when an immunosuppressed person lives in the same house. If an infection does occur, it is usually much milder than the natural disease and is referred to as an adverse reaction. Pink Book, p. 5. Further, Vaccines: What You Should Know, p. 101, states that ''vaccinated children are not at greater risk of other infections meaning infections not prevented by vaccines than unvaccinated children.''
The Department is respectful of commentators' beliefs that the decision whether to vaccinate their children should be made by them alone, and that immunizations should not be mandated. The Department understands that many commentators believe that vaccines cause more harm than good. As several commentators noted, the Department acknowledges that there is no absolutely safe vaccine. The Department has never denied that reports of adverse events and serious adverse events are made for every vaccine. The Department is also aware of the side effects listed on the manufacturer's labels. Manufacturers of products warn users of products of possible problems with products in part out of concern for liability. Because a manufacturer cannot prove that a vaccine is effective for a lifetime, it cannot say so without the possibility of legal ramifications. The Department is charged with protecting the health and safety of the citizens of this Commonwealth and with choosing the most efficient and effective way of doing so. See section 2102(a) of The Administrative Code of 1929. After reviewing the comments and the proposed rulemaking, the Department stands firm in its belief of the benefits of childhood vaccination, despite the fact that vaccines may cause adverse and serious adverse events. These factors are taken into account by the FDA when a vaccine is licensed and by ACIP when it recommends a vaccine. Before the FDA licenses a vaccine, and before ACIP makes a recommendation regarding a vaccine, these experts determine that the possibility of adverse and serious adverse events are outweighed by the dangers of the disease itself. See Vaccines: What You Should Know, p. 24, and this preamble. Therefore, the Department has not revised this final-form rulemaking regarding this topic. Tables of reported cases and vaccine-preventable diseases from 1950—2013 published by the CDC show the decrease in deaths from childhood diseases like polio and measles that have occurred with the advent of vaccinations. See Pink Book, Appendix E, p. E-1—E-8. At least 1 study determined that vaccination will prevent an estimated 322 million illnesses, 21 million hospitalizations and 732,000 deaths during the course of the lifetime of children born between 1994 and 2013. ''Benefits from Immunization,'' p. 1.
The Department also disagrees with the commentators' statement that massive underreporting of adverse vaccine events occurs because many parents do not realize the ensuing illness could be related directly to the vaccine recently received. Neither the Department nor the commentators are in a position to know the truth of this statement.
Multiple commentators stated that the Institute of Medicine, in a series of reports on vaccine safety spanning 25 years, acknowledged that there is individual susceptibility to vaccine reactions for genetic, biological and environmental reasons that have not been fully defined by science; doctors cannot predict ahead of time who will be harmed. The commentators stated that long standing gaps in vaccine safety research and emerging evidence that certain vaccines do not prevent infection or transmission of disease urgently require legal protection of physician and parental rights regarding medical and religious exemptions to vaccination for minor children. For these reasons, physician's rights and parents' and legal guardians' rights to philosophical and religious exemptions are an absolute imperative of health and civil liberty.
The Department is not amending the religious/philosophical or medical exemptions, both of which are provided for in statute.
PACIC and several commentators stated that although the Department mentioned adverse reactions to vaccines, it does not discuss them. One commentator stated that the Department dismissed the possibility of these reactions as fairly rare. The commentator stated that complications from having a disease are rare as well. The commentator stated that since the Vaccine Adverse Event Reporting System (VAERS) is a voluntary reporting system, it is unknown how rare the adverse reactions are. The commentator stated that the risk of adverse reactions must be weighed against the risk of vaccine-preventable disease in the United States. The commentator stated that this is never done, as the risks of these diseases in developing nations is the risk we are asked to consider.
The Department disagrees with the commentators. In fact, ACIP reviews the costs of adverse events as part of cost-effectiveness studies done before adding vaccines to its recommended list. Cost-effectiveness studies of meningococcal vaccines do exist. The Department reviewed them, along with ACIP's recommendations, and discussed them more fully in the comments regarding § 23.83(c)(2). Further, the Department cited the ''Benefits from Immunization'' study in which adverse effects are reviewed as part of a review of the cost-effectiveness of the VFC Program in cohorts of children born between 1994 and 2013. The study finds that vaccines save both lives and money. Childhood vaccines clearly reduce the incidence of disease and death. Although no vaccine is 100% effective, vaccines have prevented millions of deaths each year from preventable infectious diseases. See generally ''Benefits from Immunization.'' School settings are an ideal place for unprotected children to contract communicable and potentially dangerous diseases. Requiring immunity for school attendance protects that child and others from unnecessary illnesses.
One commentator stated that it is not true that there is no cost to the public when one examines the amount of disease which now exists in the Nation after vaccination rates have increased with much fuller schedules. The commentator asked that the Department consider holding pharmaceutical companies more accountable for possibly failing products rather than taking more and more rights away from parents and guardians.
The commentator noted that each disease poses a different level of risk, as does each vaccine, and it cannot be assumed that all vaccines are risk free, nor should it be assumes that all diseases are deadly in the United States. The commentator stated that measles is undoubtedly deadly in developing countries lacking adequate food and clean water, but has never been particularly problematic in the United States, not even in the prevaccine era. According to the commentator, the death rate for measles in 1921 and 1922 was 4.3 per 100,000 infected, which is extremely low. Since it was so low then, without antibiotics or other treatment regimens, the commentator stated that it would surely be less problematic today. The commentator noted that since 1990, the MMR vaccine has been reported in conjunction with serious side effects, such as stroke, hearing loss, pancreatitis, seizure and other things, in 7,502 reports in VAERS, as well as 358 deaths, the vast majority in children under 3 years of age. The commentator stated that every case of children with measles, however mild, is reported but not about vaccine reactions and ''surely those children matter too.''
The commentator stated that not all reactions are in children. According to the commentator, incidences of arthritis and arthralgia are generally even higher in vaccinated women than in vaccinated children, and the reactions are more marked and of longer duration. The commentator wondered who had decided that months or even years of joint pain in up to 26% of women is acceptable, and exactly who had decided that this pain is well tolerated.
The Department disagrees with the commentators. The Department disagrees that vaccines have not been effective in preventing and controlling vaccine preventable childhood diseases. See Pink Book, Appendix E. The Department notes that disease rates have fallen over the last century due to vaccination. See ''Achievements in Public Health,'' which stated that ''[t]his report documents the decline in morbidity from nine vaccine-preventable diseases and their complications—smallpox, along with [diphtheria, pertussis, tetanus, poliomyelitis (paralytic), measles, mumps, rubella and Haemophilus influenzae type b].'' Polio caused by wild-type viruses has been eliminated from the Western Hemisphere. See ''Achievements in Public Health,'' p. 2; Vaccines: What You Should Know, p. 46; Haymann, MD, D. L., editor (2004), Control of Communicable Diseases Manual, Washington, DC: American Public Health Association. An average of 16,316 paralytic polio cases and 1,879 deaths from polio were reported each year from 1951 to 1954. With the licensure of polio vaccine in the United States in 1955, polio incidence declined sharply to less than 1,000 cases in 1962 and remained below 100 cases after that year. See ''Achievements in Public Health,'' p. 2. Per ''Achievements in Public Health,'' p. 2, ''[i]n 1994, every dollar spent to administer oral poliovirus vaccine saved $3.40 in direct medical costs and $2.74 in indirect societal costs'' and the last documented indigenous transmission of wild poliovirus in the United States occurred in 1979.
Measles cases have also declined since the introduction of a vaccination. According to the Pink Book, before 1963 (which was the year the first measles vaccine was licensed), approximately 500,000 cases and 500 deaths of measles were reported annually, with epidemic cycles every 2 years. Pink Book, p. 214. After the introduction of the vaccine, the incidence of measles decreased by more than 95%. Pink Book, p. 214. In 1983, 1,497 cases were reported, the lowest annual total ever reported up until that time. After that date, there was an occurrence of measles among already vaccinated children, which led to a recommendation for a second dose in children 5 years of age to 19 years of age. Pink Book, p. 214. From 1989 to 1991, there was a dramatic increase in cases reported, along with a change in age distribution. Forty-five percent of the cases appeared in children younger than 5 years of age. According to the Pink Book, the most important cause of the resurgence of measles from 1989 to 1991 was low vaccination coverage, although measles susceptibility of infants under 1 year of age may have decreased, since mothers who were vaccinated transferred less antibodies to infants in utero than mothers who had had the ''wild disease.'' Pink Book, p. 215. Rates again dropped significantly because of intensive efforts to vaccinate preschool-aged children.
The outlier in this evidence is pertussis. The waning of pertussis immunity provided through vaccination has been well documented and has been noted by numerous commentators. The waning of immunity is due to concerns with the safety of the whole-cell pertussis vaccine (DTwP3 ), which led to its replacement by the acellular pertussis vaccine, DTaP. ''Pertussis Epidemic—Washington, 2012'' (Pertussis Epidemic), MMWR, 61(28) (2012), 517—522, retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6128a1.htm. See also Pink Book, p. 266, which states that ''[t]he epidemiology of pertussis has changed in recent years, with an increasing burden of disease among fully-vaccinated children and adolescents, which is likely being driven by the transition to acellular vaccines in the 1990s.'' The ''Pertussis Epidemic'' study of an epidemic of pertussis in Washington in 2012 led the authors of the study to conclude that although vaccinated children can develop pertussis, they are less infectious, have milder symptoms and shorter illness duration, and are at reduced risk for severe outcomes, including hospitalization. ''Pertussis Epidemic,'' p. 4. The ''Pertussis Epi- demic'' study recommended that efforts should focus on full implementation of DTaP and tetanus and diphtheria toxoids and acellular pertussis vaccine (Tdap) recommendations to prevent infection and protect infants. ''Pertussis Epidemic,'' p. 4.
The Department further notes with respect to the MMR vaccine that the individual antigens that make up the MMR vaccine are no longer available in the United States. The Department continues to include the single antigens in final-form § 23.83(b)(3) because of the possibility that a child from another country may enter this Commonwealth with single antigen vaccines. As the Department has stated, childhood vaccines reduce the incidence of disease and death. Although no vaccine is 100% effective, vaccines have prevented millions of deaths each year from preventable infectious diseases.
Further, the Department notes that this final-form rulemaking is limited to: clarifying that the diphtheria and tetanus vaccinations are no longer available without a pertussis component, thereby in effect adding a pertussis dose for school attendance; adding a dose of MCV in the 12th grade; extending the school reporting period; and reducing the provisional period during which a child may be admitted to school without the required immunizations. The cost implications of this final-form rulemaking are limited to those provisions, and do not extend to the general requirement of vaccination for school entry and attendance.
PACIC and another commentator stated that most other states do not require home-educated students to comply with immunization regulations. PACIC and the commentator stated that children who do not attend a traditional public school should be exempt from the regulations because they will not be contributing to the school's herd immunity. One commentator noted that this would increase the vaccination rates in schools.
Several commentators raised the issue of vaccines related to homeschooling their children. One commentator stated that she had made decisions to vaccinate her child for some things, but not others, when she felt they were unnecessary or the risk was too high, and that she refuses vaccines for herself as well. Several commentators stated that their children were not around other children on a daily basis, in a classroom where they can affect others by being ill, since they were homeschooled. Another commentator stated that she believed the urgency for homeschooled children was considerably less than for children in school situations, so that these children should have wider parameters for compliance. One commentator stated that as a homeschooling parent, she should have the right to decide what was right for her child. She stated that while vaccines are necessary in certain instances, there needs to be flexibility with the requirements. One commentator stated that it concerned her that the regulations applied to all children, regardless of whether they are in a public school setting or a homeschool setting.
The Department has not amended the requirement of when immunizations are required and who is required to get them. Immunizations are required for school entry and attendance, and have always applied to homeschooled children. In § 23.83(a), ''school'' includes homeschools, cyber schools and charter schools. Further, the Department notes that a parent or guardian who refuses to obtain the vaccinations for his child because of a religious belief or a strongly held moral or ethical conviction that rises to the level of a religious belief, or who has a medical contraindication to a vaccine, may seek an exemption from these requirements, and still attend school, whether in a brick and mortar building or in a homeschool environment.
IRRC also noted that commentators asked the Department to exempt homeschool and cyber school students, and asked whether the Department had considered this concern.
The Department has not newly included children who are homeschooled or in cyber schools in this final-form rulemaking. They are already required by law to comply with the vaccination requirements in § 23.83(b). The Department would have to amend its regulations to exempt homeschooled and cyber-schooled students. While the regulations regarding immunizations in schools are primarily aimed at protecting children in brick and mortar schools, that is not its only aim. Although homeschooled children and children in cyber schools may not be around other children on a daily basis in school, they are around children and adults in grocery stores, malls, playgrounds, movie theaters and other public areas. The dangers of passing diseases to persons who cannot receive vaccinations are present in places other than schools. Herd immunity is really ''community immunity'' and a student's wider community, as well as the school, is impacted by failure to immunize.
The Department does have the authority to make certain decisions considered within its police powers, that is, its authority to protect the general public from harm. The courts have upheld this authority. See Stull v. Reber et al. (Stull), 215 Pa. 156 (1906). Requiring immunizations for school entry and attendance falls within that police power. The General Assembly has delegated, as it is legally authorized to do, that authority to the Department to implement through the Public School Code of 1949 (24 P.S. §§ 1-101—27-2702), The Administrative Code of 1929 (71 P.S. §§ 51—732) and the Disease Prevention and Control Law of 1955 (35 P.S. §§ 521.1—521.21). The Department cannot force a parent to have a child vaccinated. The parent always has the choice whether or not to comply with the requirements. Making certain choices may have certain consequences. For example, refusal to obtain vaccinations may result in exclusion from school until the appropriate exemptions or medical schedules are put into place. Further, if an outbreak were to occur, unvaccinated persons could be excluded from school for a relatively longer period of time; for a measles outbreak, for example, persons who are susceptible, that is, persons without immunity, may be excluded from school for a protracted period of time. As one commentator mentioned, this might not seem to be as much of an issue with children who are homeschooled. However, failure to obtain vaccinations may have implications beyond the child or the school, since a child who is homeschooled has contact with other children and adults in public areas.
Comments regarding ''herd'' or community immunity, vaccine effectiveness and natural immunity
Multiple commentators, including PACIC, stated that the Department's citation of ''herd'' or community immunity as a basis for requiring additional immunizations is incorrect, and that the Department did not explain how herd immunity prevents the spread of disease. IRRC also requested that the Department provide specific data to support the need for this final-form rulemaking regarding herd immunity. Some commentators stated that the theory of herd immunity was first developed during the study of individuals who had attained natural immunity through the course of infection, that is, had the ''wild disease,'' not those who had been vaccinated. According to PACIC, children would experience illness from wild virus exposure, and nonvaccinated adults were naturally re-exposed to the wild virus as they cared for sick children, so their natural immunity was boosted. PACIC stated that this immunity is life long, and can be transmitted from mothers to children through breastfeeding. PACIC stated that this protects children until they are old enough to acquire the wild virus naturally and begin building life-long immunity. PACIC stated that vaccines do not replicate this natural cycle for the following reasons:
• Mothers who receive vaccines can have a lower concentration of virus-specific antibodies than mothers with naturally acquired immunity.
• As viruses mutate over time, static vaccines offer limited protecting from evolving disease strains.
• Vaccine immunity is temporary and frequently ineffective, with up to 76% of people not responding to repeated vaccinations. Persons with nearly 100% vaccination compliance are still experiencing outbreaks. In 18 different measles outbreaks in North America, vaccinated children constituted 30% to 100% of measles cases.
• Vaccination sometimes shifts the disease from childhood to more vulnerable age groups, including the infants and the elderly, when they can be more serious.
• Even after six doses of Tdap vaccine, effectiveness declined to 34% after 2 to 4 years, likely contributing to increases in pertussis among adolescents.
Many other commentators agreed with these comments. Several commentators requested that herd immunity be responsibly omitted as a scientific basis for increasing vaccination schedules. One commentator stated that no vaccine has ever prevented a disease, it has merely lessened the symptoms.
One commentator stated that the Department made the statement regarding herd immunity without statistics or studies. The commentator stated that this theory, which was based on the assumption that natural immunity is the same as vaccine-based immunity, can no longer be used. Two commentators stated that a recent mumps outbreak at Harvard University was among students who were all vaccinated. The commentators noted that there was a recent whistleblower lawsuit filed by two Merck immunologists in this Commonwealth who claimed that mumps efficacy data was manipulated by the addition of rabbit blood to boost immunity markers. One commentator stated that Merck could lose its MMR monopoly in the United States if its effective rate dropped too low. According to the commentators, a PubMed study found 18 reports of measles where 71% to 99.8% of students were immunized against measles. According to the commentators, 30% to 100% of all measles cases in these outbreaks occurred in previously immunized students. According to the commentator, the study's authors determined that as immunization rates rise, measles becomes a disease of immunized persons.
The Department disagrees with the commentators. The question of childhood immunization in general is not at issue here. The Department already requires certain immunizations for school entry and attendance, including Tdap in the 7th grade, and those requirements will not change regardless of the outcome of this final-form rulemaking. Vaccines have prevented millions of deaths each year from preventable infectious diseases, and will continue to do so.
The Department did use the concept of community or herd immunity to support its decision to reduce the provisional period. Maintaining or increasing herd immunity will decrease the threat of vaccine-preventable diseases in schools, and therefore in the general populations. Many of these are diseases are more prevalent among school age children, but can quickly spread to the adult population as well. Protection of the public from vaccine-preventable diseases can be accomplished by ensuring the continuance of herd immunity or community immunity among children in schools. Low vaccination rates can lead to a waning of herd immunity, which is defined as the protection for the community against certain communicable diseases that arises when a critical mass of persons are immunized against those diseases. Herd or community immunity is a means of protecting a whole community from disease by immunizing enough people so that no sustained chain of disease transmission can be established. By breaking the chain of a disease transmission, vaccination protects more than just the vaccinated person; it also protects people who have not been, or cannot be, vaccinated because they are too young or too sick. Willingham, E. and Helft, L. (2014), ''What is Herd Immunity,'' PBS Online, retrieved from http://www.pbs.org/wgbh/nova/body/herd-immunity.html. Salathe, M. (2015), ''Herd Immunity and Measles: Why We Should Aim for 100% Vaccination Coverage,'' The Conversation, retrieved from http://theconversation.com/herd-immunity-and-measles-why-we-should-aim-for-100-vaccination-coverage-36868.
Although many commentators disagreed with the concept of herd immunity, it does exist and is a driving force behind much of vaccine policy. The more members of a community, including a school community, who are immune to a given disease, the better protected the whole community will be from an outbreak of disease, and the less likely the disease will spread from that community to other communities. When unvaccinated children, who intend to be vaccinated at some point, are allowed to continue in school for a long period of time, the ''herd'' is diluted during the time it takes them to become vaccinated. The longer the time frame in which children have to be vaccinated, the easier it is for any introduction of disease to put at risk unvaccinated children, children who are putting off vaccination, and those children who, for medical or other reasons, cannot or are not vaccinated. The sooner more children are fully vaccinated, the sooner herd or community immunity is achieved to protect at-risk children and adults who cannot be vaccinated and all children without vaccinations, whether for medical or other reasons.
The level of immunization in a population required to achieve herd immunity does differ from disease to disease, and some diseases, for example, pertussis, seem unaffected by it.4 To determine thresholds of immunity, epidemiologists set a value, called a basic reproduction number (R0), to determine vaccination rates necessary to prevent spread of disease. Marshall, MD, G. S. (2012), The Vaccine Handbook: A Practical Guide for Clinicians (Vaccine Handbook), New York: Professional Communications, Inc. This is a complex calculation and differs depending on the factors, assumptions, and methodologies various researchers use. See Vaccine Handbook, p. 42.5 These factors include how effective the vaccine is, how long-lasting immunity from both the vaccine and the infection is, and which populations form critical links in the spread of disease, since there may always exist pockets of susceptible individuals who are capable of spreading the disease. See Vaccine Handbook, p. 44.
Measles, for example, is easily spread through droplets and the air, is highly contagious and has a relatively high threshold to protect a community. Thus, experts postulate that between 92% and 95% of the population must be vaccinated to prevent the disease from spreading. Bednarczyk, R. A., Orenstein, W. A. and Omer, S. B. (2016), ''Estimating the Number of Measles-Susceptible Children and Adolescents in the United States Using Data from the National Immunization Survey—Teen (NIS—Teen)'' (Estimating the Number of Measles-Susceptible Children and Adolescents), American Journal of Epidemiology, 184(2), 148—156. Polio, which is less contagious and spreads in a different way, has a lower threshold, at around 83%. For a variety of reasons, certain other diseases are not strongly affected by herd immunity. For example, a disease in which immunity from vaccine and from infection wane over time, and for which a human host could colonize the disease without becoming ill, would not be as impacted by herd immunity as other diseases. This may be an issue with certain meningitis vaccines, although there have been studies showing that vaccination for meningitis serogroup C in Britain did create herd immunity. See ''Prevention and Control (2013),'' p. 10.
The Department does not claim that herd immunity will protect students from every infectious disease. It will protect students and adults in schools and in surrounding communities from highly contagious and serious diseases. To maintain levels of immunity to prevent the spread of potentially dangerous and highly infectious diseases—for example, measles, polio and chickenpox—approximate vaccination rates need to be 92% to 95% for measles, 83% for polio and 89% to 90% for chickenpox. See ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 153; and Glass, PhD, G. E. (2006), ''Measuring Disease Dynamics in Populations: Characterizing the Likelihood of Control,'' lecture retrieved from http://ocw.jhsph.edu/courses/publichealthbiology/PDFs/Lecture2.pdf. When herd immunity wanes because of pockets of persons susceptible to disease or for other reasons, the remainder of the population is at risk. See ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 153 and 154. ''[W]ith approximately 8.7 million children aged 17 years or younger who are susceptible to measles, there is a potential for large measles outbreaks even in the context of generally high vaccination coverage.'' See ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 153. ''[A] substantial number of children and adolescents aged 17 years or younger in the United States are susceptible to measles, with some clustering raising concerns that endemic measles transmission could be reestablished despite the overall high level of immunity.'' See ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 154.
Although the school district level data reviewed by the Department for school years 2014-2015 and 2015-2016 show rates in most school districts near or above the 92% threshold for MMR vaccination levels, individual school level data reported for kindergarten and 7th grade show a different picture in some schools. For purposes of herd immunity, the actual school a student attends is the student's particular community. It is here that the unvaccinated student would be most at risk (students do come into contact with the larger school district community, and with students from schools with potentially lower rates, although not on a daily basis). There are schools in this Commonwealth at which rates for MMR in kindergarten and 7th grade, for the portion of the school year at which the report was made, are below 92%.
In the 2014-2015 school year, when schools reported in December, approximately 26% of the kindergarten and 7th grade classes in noncyber schools in this Commonwealth6 had vaccination rates below 92% for the MMR vaccine at some point in the school year. For some of those classes, the rates were below 85%. Rates in individual schools substantially improved in the 2015-2016 school year (approximately 10% of kindergarten and 7th grade classes were below 92%) when school reporting was extended to March, but there still were schools significantly below the vaccine rates necessary for herd immunity. This means there is a period during the year in which not enough children have been vaccinated to create herd immunity for diseases like measles, which was responsible for 481,530 cases Nationwide in 1962, prevaccine, and 408 deaths of those children and adults.
Insufficient herd immunity also has the potential for school disruption, including closure, with concomitant loss of educational time, loss of work and pay for adults, need for daycare or other care for excluded children, administrative work to identify and exclude persons who are susceptible (those who can prove neither immunity nor vaccination), disease surveillance and contact tracing in the community to contain the outbreak, costs to the health care system of both the ill and the ''worried well,'' cost to parents and guardians of care for sick children, and cost to the public health care system of vaccine and prophylaxis. Although this Commonwealth has not been through a measles outbreak recently, the Department routinely conducts disease investigations and surveillance of the type that would be greatly expanded in the event of an outbreak of disease. The Department points to the costs to California because the actions taken in California would be the same as those required in this Commonwealth in the event of an outbreak. Although the actual monetary value of responding to an outbreak may differ from state to state, the types of costs and the extent of the costs are the same in any state. The longer children attending school with neither medical nor religious/philosophical reasons to avoid the vaccination, the greater the chance of an outbreak crisis like this occurring in this Commonwealth.
For example, in 1962 before there was a measles vaccine, according to the CDC, there were 481,530 measles cases and 408 deaths were reported Nationwide, with epidemic cycles every 2 to 3 years. After licensure of the measles vaccine in 1963, the incidence of measles decreased by more than 95%, and the 2-year to 3-year epidemic cycles no longer occurred. A resurgence of measles cases from 1989 to 1991 was the result of low vaccination coverage. Reported cases of measles declined rapidly after the 1989 to 1991 resurgence, due primarily to intensive efforts to vaccinate preschool-aged children. Measles vaccination levels among children 2 years of age increased from 70% in 1990 to 91% in 1997.
The Department also disagrees with the commentators' views that vaccines are ineffective. The Department has already provided data regarding the decline in childhood illness due to the introduction of vaccinations. The Department recognizes that outbreaks can occur even if vaccination rates are high. According to ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' even though the overall level of immunity to measles is generally at or higher than the lowest threshold rate for herd immunity of 92%, a substantial number of children and adolescents are susceptible to measles, with clustering of unvaccinated children raising concerns that endemic measles transmission could be re-established despite the overall high level of immunity. See ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 154. ''Herd Immunity: History, Theory, Practice'' suggests that current measles immunity levels are high enough to prohibit continued transmission throughout most of the country, but insufficient in certain urban areas where social conditions are least conducive to high vaccination rates. According to ''Herd Immunity: History, Theory, Practice,'' p. 286, given population movement, it is not surprising that measles repeatedly escapes from urban centers into schools throughout the country. This is what concerns the Department about the low vaccination rates in schools in this Commonwealth.
Further, the Department acknowledges that not all vaccines are 100% effective and, that, on occasion, immunity from some vaccines is shown to have waned. This occurred with pertussis and is why in 2011, the Department added Tdap7 as a dose for entry into the 7th grade. See 40 Pa.B. 2747 (May 29, 2010). The fact that immunity can wane does not mean that children, and adults, should not be vaccinated. The MMR vaccine, according to the Pink Book, is approximately 95% effective. Measles antibodies develop in approximately 95% of children vaccinated at 12 months of age, and 98% of children vaccinated at 15 months of age. More than 99% of persons who receive two doses off measles vaccine, with the first dose administered at no earlier than the first birthday, develop serologic evidence of measles immunity. Pink Book, p. 218. Seroconversion rates are similar for single antigen measles vaccine and the MMR. Pink Book, p. 218. Two doses of the mumps or MMR vaccine is 88% effective, with a range of 66% to 95%. Pink Book, p. 253. Rubella vaccine is 95% effective, with the same seroconversion rate for single antigen vaccine and MMR. Pink Book, p. 331. Three doses of DTaP and one dose of Tdap have a similar efficacy, 80% to 85%. Pink Book, p. 268. Varicella vaccine is 70% to 90% effective against any varicella disease, and 90% to 100% effective against severe varicella disease. Pink Book, p. 362. MCV wanes unless a booster is administered, which is why the Department is adding a second dose of meningitis for entry into the 12th grade. The fact that there may be a potential for waning of immunity does not mean that vaccinations should not be required.
The Department also disagrees with the commentators' discussions regarding the benefits of ''natural'' immunity versus vaccinated immunity. The Department acknowledges that natural infection may provide better immunity than vaccination.8 During natural infection, the immune system recognizes a pathogen as foreign and makes an immune response. When a pathogen causes an immune response, it is known as an antigen. Unfortunately, while the immune response gathers strength, a person is likely to be ill, as there is a struggle between the pathogen and the immune response. Antibodies are created by the immune response. Antibodies are specific to antigens, and have the ability to remember them, so that if the same or a very similar antigen tries to infect the person again, the immune response will be faster and stronger and will protect the person from infection and illness. The cost of attaining natural immunity can be great. A child can be paralyzed from a natural polio infection, liver failure from a natural hepatitis B viral infection, deafness from having the measles or pneumonia from varicella. See Vaccines: What You Should Know, p. 99.
The commentators argued that only natural immunity can be passed from a mother to child through breastfeeding and that this then protects the child until the child can catch the disease and build up natural immunity itself.
The Department acknowledges that antibodies passed from mothers who have had a disease to children may last longer than antibodies from vaccinated mothers. See Pink Book, p. 215. The Department disagrees with commentators' argument that vaccinations do not work as well as ''natural'' immunity because mothers who have not been vaccinated, but who have had disease, pass stronger immunity to their children, which lasts until the children develop their own immunity. Once the mother's antibodies wear off, the child is vulnerable and must either be vaccinated or risk the disease. For example, maternal antibodies against measles may only last as long as 10 months. ''Estimating the Number of Measles-Susceptible Children and Adolescents,'' p. 153. After this time, children are susceptible and if left to develop their own immunity risk contracting a serious disease with a serious risk of high fever, painful rash, ear infections, oral sores, dehydration, diarrhea, blindness and death.
One commentator stated that not all medical professionals see people as cattle that can be lined up at a ''mass immunization clinic,'' as was suggested by another commentator. The commentator stated that it could as easily be argued that herd immunity does not work and the science is clear for those that choose to do their research beyond the education prepared and paid for by the pharmaceutical/vaccine industry, which is a billion dollar industry, and laughs all the way to the bank. The commentator stated that it is offensive to suggest that people should line up at clinics and let nurses and pharmacy technicians who do not know their medical history give vaccines instead of at doctors' offices.
The Department questions the use of the term ''mass immunization,'' which is not appropriate in the context of this final-form rulemaking. The type of mass immunization clinics referred to by some of the commentators, who have suggested that this might help to ''catch-up'' children who do not have all the required vaccines, are not viable in the present circumstances. Unlike smallpox and polio, there is not a public health ''push'' to eradicate a disease, which involved public health at the Federal, state and local levels, and during which children were lined up to be given vaccinations. As the Department has noted, the funding for the provision of vaccine in this way no longer exists, and there are eligibility requirements that children must meet to get immunizations with Federal vaccine. It should be noted that even though children were lined up to receive immunization at those immunization clinics, which were run as part of a public health effort to eradicate polio and smallpox, parental consent was required. In the event immunization clinics are held again for a public health reason, parental consent will always be required. A parent or guardian who denies consent does run the risk of having his child excluded from school unless the parent or guardian can provide an exemption.
It should also be pointed out that these circumstances do not technically meet the terms of 42 Pa.C.S. § 8334 (relating to civil immunity in mass immunization projects), which sets out the circumstances under which a private physician, not receiving remuneration, may operate a clinic and, if approved by the Department, have immunity for those actions.
PACIC commented that the Department stated that vaccine rates were lower than optimal, that this statement was vague and should be quantified. IRRC also requested that the Department provide specific data to address vaccination rates.
The Department's immunization data is derived from its School Immunization Law Reports (SILR). The ''School Immunization Summary 2014-2015'' and the ''School Immunization Summary 2015-2016,'' which contain county level data, are available on the Department's web site, as previously provided. Data from individual schools, referred to as ''school level data'' in this preamble, for 2014 and 2015 are attached to the RAF for this final-form rulemaking as Attachments 1 and 2, respectively. The Department provides county level data routinely. For purposes of this final-form rulemaking, the Department is providing school level data, but is redacting the names and addresses of the schools to protect the confidentiality of those schools. It is not the Department's intention to call attention to any one school, but to underscore the importance of vaccine rates.
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1 In the 2015-2016 school year, the Department pushed the school reporting deadline back to March 2016.
2 The study considered program costs, including cost of the vaccine, cost of administration, vaccine adverse events, and parent travel and work time lost. The cost analysis was conducted from both health care (direct) and societal (indirect and direct) perspectives. Direct costs included outbreak control and outpatient and inpatient visits. Indirect costs included the productivity losses from premature mortality, which was estimated using the human capital approach. Costs for work were determined by the number of days of missed work (for provision of care to sick children, for illness among cohort members or for resulting disability) multiplied by the daily wage rate associated with the value of lost wage-earning work and the imputed value of housekeeping and home-care activities. The cost of vaccine administration from a private provider was estimated at $29.07. The cost of vaccine administration at a public clinic was estimated at $8.15. The study's authors assumed that caregivers take 2 hours off from work to take the child for a vaccination, based on previous economic studies. The study's authors then assumed that the average cost for these caregivers was $18.19 per hour, and that the cost for travel to a clinic was $23.45. See VFC Publications: Supplement, Appendix: Methods for the cost-benefit analysis in ''Benefits from Immunization,'' retrieved from http://www.cdc.gov/vaccines/programs/vfc/pubs/methods/.
3 DTwP is diphtheria and tetanus toxoids, and whole cell pertussis vaccine. Diphtheria and tetanus toxoids and pertussis is also whole cell pertussis vaccination and is acknowledged by the Department as an appropriate vaccination along with DTaP.
4 This does not mean that vaccination against pertussis has no benefit. The Department has discussed this issue more fully in this preamble.
5 The history and theory of herd immunity, the methodologies and theories different researchers use to determine disease transmission is discussed in an article by Fine, P. E. M. (1993), ''Herd Immunity: History, Theory, Practice,'' Epidemiologic Reviews, 15(2), 265—302. This article, at p. 282, points out the difficulties of making precise estimates of herd immunity thresholds in any particular context based on differing assumptions (for example, maternal immunity, variation in age of vaccination and geographical heterogeneity). Table 5 of this article shows threshold rates from different studies for measles of from 55% to 96% not specified, based on the methods of calculation and assumptions used by various authors, and raises issues with the assumptions used in several of those calculations. This article did not offer an opinion as to the appropriate basic reproduction value and threshold rates for measles. This article stated on p. 286 instead that ''experience does suggest that most theoretically-derived estimates of vaccination uptake and herd immunity thresholds [for measles] have been optimistically low, because they do not cater for important heterogeneity within real populations.'' The Department has utilized a threshold rate of 92% to review its data, based on the articles it has reviewed, and the clear acknowledgement by those articles that measles is extremely infectious. ''What is Herd Immunity'' provided a threshold range of between 83% and 95% for measles, citing ''Herd Immunity: History, Theory, Practice,'' while acknowledging that measles is so infectious that the threshold immunity required to protect a community is 95%.
6 Based on Department of Education information relating to cyber schools.
7 DTaP is the pediatric formulation of the tetanus and diphtheria toxoids and acellular pertussis vaccine. Tdap is the adolescent and adult formulation.
8 This does not hold true for all vaccines, for example, tetanus.
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