Adoption of N.J.A.C. 8:57-4 (Immunization of Pupils In School) with Amendments and New Rules

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1 JON S. CORZINE Governor DEPARTMENT OF HEALTH AND SENIOR SERVICES PO BOX 360 TRENTON, N.J FRED M. JACOBS, M.D., J.D. Commissioner TO: FROM: SUBJECT: Herbert Yardley, M.A. Chair Public Health Council Fred M. Jacobs, M.D., JD. Commissioner Adoption of N.J.A.C. 8:57-4 (Immunization of Pupils In School) with Amendments and New Rules Enclosed for your review and approval is the adoption package with substantive changes not requiring additional public notice or opportunity to comment of the immunization rules for N.J.A.C. 8:57-4, which will add the influenza vaccine and pneumococcal conjugate vaccine (PCV) vaccine as required vaccinations for children attending licensed child care centers and also will add meningococcal vaccine and Tetanus, diphtheria, and pertussis (Tdap) vaccine for children in Grade Six. Many of the amendments for adoption are technical, represent improved grammar, style, and articulation, and serve to update or cross-reference publications and laws incorporated by reference. There were also a number of substantive amendments to existing rules. The Department seeks to present the notice of adoption at the December meeting of the Public Health Council prior to publication in the New Jersey Register. The Department of Health and Senior Services, Division of Epidemiology, Environmental and Occupational Health, published in the December 18, 2006 issue of the New Jersey Register at 38 N.J.R. 5284(a), notice of proposed amendments and new rules to N.J.A.C. 8:57-4. A public hearing was held January 26, 2007, and the public comment period ended February 16, The Department received a large number of comments in opposition to the proposal. No changes have been made to the proposal as a result of those comments. The Department is now proceeding to adopt the amendments and new rules with agency-initiated substantive changes not requiring additional public notice or opportunity to comment. Although originally proposed for implementation on September 1, 2007, it has become necessary that the implementation and operative date of these adopted amendments and new rules be extended to September 1, The Department intends to make the four-day grace period at N.J.A.C. 8: (b) effective upon publication of the Notice of Adoption, rather than waiting until September 1, This action will permit these rules to more immediately medically conform with the practices of most pediatricians and physicians following the published ACIP and AAP recommendations which allow for a four-day grace period. The Department s agency-initiated

2 changes on adoption reflect the necessary changes in the rule text due to the new September 1, 2008 operative date. A summary of this subchapter, including the new rules and the more substantive amendments for adoption, and major issues of concern expressed by comments presented in writing and verbally at the public hearing follow. Anticipated questions and answers for your review, as determined by the greatest number of opposition statements the Department received during the public comment period, are attached. Subchapter 4. Immunization of Pupils in Schools: This rule establishes a set of uniform immunization requirements applicable to children attending all schools and preschool facilities. It ensures that all children attending school have been immunized against specific vaccinepreventable diseases so that the transmission of vaccine-preventable diseases is curtailed. It also provides for the collection of data on the immunization status of children attending schools and preschool facilities in order to identify areas of the state where immunization rates are not adequate so that intervention measures can be instituted. There are four new vaccines to be mandated upon this adoption: A new rule at N.J.A.C. 8: requires those children who are two to 59 months of age attending licensed child care centers to receive pneumococcal conjugate vaccine. A new rule at N.J.A.C. 8: requires those children who are six to 59 months of age attending licensed child care centers to receive one annual dose of influenza vaccine by December 31 of each year. Amendments at N.J.A.C. 8: (h) through (j) requires children born on or after January 1, 1997 and enrolled in Grade Six or transferring into a New Jersey school from another state or country to receive one booster dose of the Tetanus, diphtheria, and pertussis (Tdap) vaccine. A new rule at N.J.A.C. 8: requires children born on or after January 1, 1997 and enrolled in Grade Six or transferring into a New Jersey school from another state or country to receive one dose of meningococcal vaccine. The more noteworthy amendments to be adopted include the following: An amendment at N.J.A.C. 8:57-4.5(e) requires schools and child care centers to provide a 30-day grace period for pupils coming from out-of-state or out-of country to remain in school while they obtain their immunization record documentation. An amendment at N.J.A.C. 8:57-4.8(a) permits schools and child care centers the option to complete and submit the required annual immunization status report to the Department on line, in addition to submission of the report through a mail service. A related amendment at N.J.A.C. 8:57-4.8(c) establishes a new deadline that gives schools and child care centers until January 1 of each year, instead of December 1, to summit the required annual immunization status report. 2

3 An amendment at N.J.A.C. 8: (d) permits the Commissioner to suspend a specific vaccine requirement(s) as a result of a state or national vaccine shortage. An amendment at N.J.A.C. 8: (b) permits all mandated vaccine doses required in this subchapter, when given within four days of the specified minimum age or a stated dose spacing interval, to be counted as a valid doses and not requiring revaccination. The rules generated a large number of comments (103) provided either in writing or verbally during the public hearing, particularly among those individuals and groups opposed to vaccine mandates. Most commenters opposed the current and expanded immunization rules for children in schools or child care centers, without a philosophical provision for parents to opt-out of complying with the rules. Although the Department proposed no changes to the existing language for religious exemptions at N.J.A.C. 8:57-4.4, a vocal minority of parents and other advocates for expanded parental choice and vaccine critics have used the rulemaking process, as they have in previous years, as an opportunity to gain a more liberal expansion of the religious exemption by adding a philosophical exemption to these rules. Arguments in opposition to these requirements included parental rights to choose whether or not to vaccinate their children and the need for a philosophical exemption from the immunization regulations; concerns about thimerosal in some inactivated influenza vaccine formulations and use of multiple vaccines as a cause of autism; concerns about harmful side effects of vaccines and about the duration of vaccine induced immunity; concerns about the need for an influenza vaccine mandate given the benign nature of the disease; concerns over low vaccine efficacy rates and about various vaccine ingredients; concerns over an inadequate vaccine supply; and concerns that these additional vaccine requirements only serve to benefit pharmaceutical companies. The Department addressed the comments in 103 responses. We will be happy to answer any questions that you may have. Thank you. Attachments: Adoption Notice Questions and Answers 3

4 Questions and Answers: Adopted New Rules and Amendments to N.J.A.C. 8: With so many vaccines now being mandated, why can t parents have a philosophical or parental choice exemption added to the immunization rules? (75 commenters) The four new vaccines being mandated are intended to protect the individual child, classmates, teachers and staff, and the larger society from certain diseases which are now vaccine preventable as a result of recent medical technology breakthroughs. Parents assume and expect that their children are learning in a school environment that is as disease free as is possible and that such protection is equitably incumbent upon all. Most parents recognize and accept that there may be a small number of instances when a minority or children by virtue of health condition or religious belief may be granted a medical or religious exemption from the immunization rules. It is for this reason that virtually all states permit medical and religious exemptions from their rules, while a minority of states also permit a philosophical exemption. Since the mid-1980 s vaccine critics in New Jersey and other states have initiated efforts to weaken or restrict the applicability of school immunization rules and to advocate for the legislative or rulemaking addition of a philosophical exemption from these rules. Most of their efforts focus on petitioning for the establishment of a philosophical exemption. When these efforts were successful in some states, it was achieved through legislative rather than state health agency initiative. The statewide immunization rules in New Jersey were first established in Since the 1980 s the Department, cognizant of its public health mission, has consistently opposed the addition of a philosophical exemption to the immunization rules through the administrative rulemaking process. Any initiative to add a philosophical exemption will require legislative action and statutory change. Although several bills to establish a philosophical exemption have been introduced in the New Jersey Legislature since 1998, none have passed that body or been signed into law. 2. Why is the Department mandating more vaccines for children in schools and child care centers when they may be dangerous and harm children? (35 commenters) Vaccines are among the safest drugs administered to children and adults. Vaccines have been administered to virtually all children in the United States since the 1960 s and have dramatically reduced the incidence of disease and complications due to disease by 90 percent or greater. No drug or vaccine is 100 percent safe or without some possible side-effects, however, the sideeffects and serious adverse events following vaccine administration are rare given the number of children being vaccinated and the number of vaccines doses they routinely receive. Vaccine safety is nationally monitored during prelicensure clinical trials and also during postlicensure surveillance systems and studies such as the Vaccine Adverse Event Surveillance System (VAERS), the Vaccine Safety Datalink (VSD) project with health maintenance organizations, and a network of Clinical Immunization Safety Assessment Centers (CISA). The four vaccines now being added to list of required vaccines have received licensure from the United States Food and Drug Administration and are deemed to be safe. There is no evidence that any of the ingredients or substances contained within these four vaccines exceed federal standards, that would render them toxic or dangerous to people. The four vaccines are all routinely medically recommended for all children by respected medical professional organizations and advisory 4

5 groups such as the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP). There are no evidence-based scientific studies, nor a medical consensus, that suggests the currently used vaccines or the four vaccines to be required in New Jersey have contributed to, or directly caused any widespread incidence of severe health conditions such as autism, multiple sclerosis, sudden infant death syndrome, or other serious disorders. While the Department recognizes that rarely some serious adverse events following vaccination can temporally occur, these adverse events do not outweigh the benefits that vaccines have provided to the entire society by preventing serious diseases, disease complications, hospitalizations, and some deaths. The routine use of vaccines among children attending schools and child care centers has helped create a more disease-free and healthier learning setting and living environment for all. 3. Why is the Department mandating influenza vaccine, which may contain thimerosal and cause autism? (72 commenters) The preservative thimerosal, an ethylmercury substance used in vaccines for decades, has been removed from all routinely administered pediatric vaccines in the United States, except some inactivated influenza vaccine formulations, since 2001 as a precautionary measure. This effort was part of a larger FDA initiative to reduce human exposure to mercury found in drugs and food. Thimerosal has been used as a preservative in multi-dose vials of vaccines to prevent bacterial contamination. There is no thimerosal in the meningococcal conjugate, pneumococcal conjugate, or the Tdap vaccines. There are currently manufactured thimerosal-free influenza vaccines available for pediatric administration and some other influenza vaccine products with only trace residual amounts left after the post-production thimerosal removal, but these minute amounts have no biological effect and are well within the federal limits set for thimerosal content. Despite considerable debate and many national and international studies on the subject of thimerosal, there has been no convincing data or evidence that ethylmercury in the amount previously used in vaccines causes harm to the developing nervous system. The Department recognizes that autism is a devastating disorder in New Jersey and elsewhere that exacts great emotional and economic burdens upon families and school systems caring for autistic children and its cause remains unknown. Since 2002, there has been a Governor s Council on Autism established in New Jersey to present and deal with some of the issues parents are confronted with in the care of an autistic child. In 2007, the New Jersey Legislature passed into law a series of autism- related bills to establish a statewide autism registry, augment funding for the Governor s Council on Autism, and to provide for increased autism awareness and training for teachers and physicians. The CDC and National Institutes of Health (NIH) are working at the national level to fund studies to assess health effects of thimerosal and to see if there is any association between thimerosal and autism, learning or developmental disorders, or other chronic diseases or adverse health outcomes. The Institute of Medicine has reviewed and studied data in 2001 and in 2004 and found no evidence that thimerosal causes autism, but they have recommended continued research and studies. International and national studies performed in recent years have not identified a causal association between thimerosal-containing vaccines and the onset of autism in children. Other ecological studies have likewise not demonstrated that with the removal of thimersol-containing 5

6 vaccines there has been a concomitant decrease in the number of cases of autism being diagnosed. The most recent studies being published on the cause of autism are suggesting that autism has a strong genetic component, although environmental factors also remain under study. In summary, the currently available medical evidence to date does not support a causal association between vaccine previously containing thimerosal and autism, although researchers are continuing to search for the cause of autism. Since 2001, all manufactured vaccines administered to children contain no thimerosal, except some formulations of influenza. There are sufficient quantities of thimerosal-free influenza vaccines being produced that are and will be available for distribution and administration to preschool-aged children attending child care centers in New Jersey; With each successive year, the vaccine companies are manufacturing more preservative-free influenza vaccine. 4. Who is likely to oppose these amendments and new rules? Some parents rights groups, vaccine critics, autism advocacy organizations, and alternative medicine practitioners will likely continue to oppose existing requirements, these recently adopted new vaccine requirements, and future immunization requirements as they have since the mid-1980 s. In more recent years, these groups and persons have opposed the hepatitis B vaccine requirement in 2001 and the varicella (chickenpox) vaccine requirement in There remains a small but organized and vocal core of parents and others who erroneously feel that the dangers of vaccines outweigh the risk of diseases they prevent. There is increasing resistance from the public on new state vaccine mandates and a demand for more informed parental choice in vaccinations for children and the establishment of a philosophical exemption to the immunization rules. These groups and individuals over the years have also lobbied the New Jersey Legislature to pass a statute permitting a philosophical exemption to the immunization rules, without success. There will likely be no opposition to the adopted amendments since most of the amendments will improve administrative procedures, provide schools and child care centers an additional month to complete their annual report, and provide a four-day grace period related to the timing and intervals of vaccine administration. 6