By Gail H. Javitt, JD, MPH, Of Counsel at DLA Piper
Just in time for the peak of flu season, a New York trial court issued a decision on December 17 striking down a New York City rule that required children to have influenza vaccinations in order to attend city-licensed preschools and day-care centers. The case, Garcia v. New York City Department of Health, brings renewed attention to the oft-contentious debate regarding whether, and under what circumstances, state and local governments can or should mandate childhood vaccination as a condition of day care and/or school attendance.
Proponents of vaccination typically cite health benefits, both to individuals receiving them and the broader population, as well as the low risk vaccinations pose to most people. Opponents counter by citing parental autonomy and health concerns that allegedly stem from vaccinations—in particular autism—though the claim of a link between autism and vaccination has been widely repudiated. Parents opposing New York City’s requirement made these arguments two years ago, when the rule was first implemented, and also contended that unlike other childhood vaccinations the flu vaccine has low, and variable, rates of efficacy, particularly in young children.
State vaccine mandates generally track with the recommendations of the Center for Disease Control’s Advisory Committee on Immunization (ACIP). All 50 states and the District of Columbia mandate vaccination of children against, at a minimum, measles, mumps, rubella, diphtheria, tetanus toxoid, acellular pertussis, and varicella as a condition of public school attendance, and 47 of those jurisdictions also have parallel mandates for children attending private school.
Some states, like New York, mandate the additional ACIP-recommended vaccines Haemophilus influenzae type b (Hib), pneumococcal disease, meningococcal disease, and/or hepatitis B. Only three jurisdictions require vaccination against human papilloma virus (HPV), which is recommended by ACIP for children beginning at age 11 or 12, although may others have considered such a mandate. Influenza vaccination, which ACIP recommends annually for all persons aged 6 months or older who do not have contraindications, is currently mandated by only two states, Connecticut and New Jersey.
All jurisdictions provide an exemption for health-related reasons (e.g., if a child has a weakened immune system or is allergic). Only Mississippi and West Virginia do not allow for religious exemption. Seventeen states now allow parents to opt out because of “philosophical” objections, based on personal, moral, or other beliefs; California and Vermont repealed their philosophical exemptions in 2015.
States also vary with respect to the rigor with which they require parents to demonstrate that they meet eligibility criteria, as well as regarding the degree of discretion by individual school administrators to grant or deny exemption requests. In 2015, 10 states considered or enacted legislation to require documentation (e.g., a notarized statement) by parents supporting their claimed exemption, enable the sharing of a child’s immunization records with schools and state agencies, and/or to increase disclosure of school vaccination rates to the public.
High-exemption states are associated with higher rates of disease outbreaks. Of the 131 measles cases in 2008, 95 were in children who were unvaccinated for religious or philosophical reasons.
Additionally, preliminary analysis suggests that the 2015 outbreak of measles in a California amusement park was likely related to “vaccination-hesitant parents.”
Interestingly–given the recent case in New York City—the state of New York has been in the forefront of vaccination since 1862, when it established a small pox inoculation law. Currently, the state mandates vaccination for children attending a New York school, defined as any public, private or parochial child-caring center, day nursery, day-care agency, nursery school, kindergarten, elementary, intermediate or secondary school. The law permits exemption if a physician certifies that the vaccine would be detrimental, or a parent or guardian signs a statement objecting to immunization based on sincere and genuine religious beliefs. The law allows school officials to request additional documentation from parents to support their claim of “genuine and sincere” religious beliefs against vaccination. Finally, the law permits exempted children to be excluded from school in the event of an outbreak. Perhaps not surprisingly, the overall rate of immunization in New York is about 97 percent, and the overall rate of religious exemptions is less than 1 percent.
State vaccination programs have been subject to (largely unsuccessful) challenges almost from their inception in the 1800s. In the seminal 1905 case Jacobson v. Massachusetts, the U.S. Supreme Court upheld a population-wide vaccination ordinance against a claim that it violated individual liberty, on the basis that compulsory vaccination was consistent with a state’s traditional “police powers”—the power to regulate matters affecting the health, safety, and general welfare of the public. The Court also articulated criteria that must be met for such exercise of police power to be constitutional: (1) a public health necessity (i.e., a significant threat to the population); (2) a reasonable relationship between the intervention and the public health objective; (3) an intervention that is not arbitrary or oppressive; and that (4) does not pose a health risk to its subject.
Indeed, at the beginning of 2015, a federal appellate court upheld the constitutionality of New York’s law, rejecting arguments by parents, two of whom had obtained religiously-based exemptions, that excluding their unvaccinated children from school attendance during an outbreak violated the children’s constitutional rights.
In the Garcia case, however, the state court’s ruling was not based on any alleged or identified legal defect in the state law. Rather, the Court found the city health department had exceeded the authority delegated under such law. Specifically, the Court determined that New York law did not include influenza as one of the diseases for which vaccination was mandated, and did not authorize municipalities to mandate new vaccines without the enactment of new legislation by the state legislature.
Thus, while striking down the city’s vaccine mandate, the court left the door open for state legislators to amend the law to add influenza to the list of mandated vaccines. And, indeed, on December 23, a member of the New York State Assembly, introduced legislation that would amend existing law to require influenza vaccinations for children as a condition of day-care and school attendance.
Most vaccines that are currently mandated as a condition of school attendance are intended to prevent serious infectious diseases whose transmission is facilitated by close interaction among children in the school setting. Indeed, the government’s legal basis for mandating vaccines as a condition of school attendance is highest for diseases that (1) may cause serious adverse health consequences, not just to the individual, but to the broader population, (2) cannot effectively be prevented through means other than vaccination, i.e., because they are easily spread through routine human contact, (3) have a low risk of serious side effects for most children, and (4) whose spread is facilitated through close contact of children in the school setting. As this author has written previously, imposing mandates for vaccines that do not meet these criteria risks undermining public trust, at least in the absence of a compelling and clearly-articulated rationale.
In considering the new bill during the 2016 session, New York legislators should be sure to review the proposed mandate with an eye toward the four criteria outlined in Jacobson. Specifically, they should consider, and be able to articulate, how requiring influenza vaccinations as a condition of school or day care attendance would address a public health necessity, bear a reasonable relationship to the stated public health objective, not be arbitrary or oppressive, and not pose a health risk to the vaccine-mandated population. Legal precedent for more than 100 years indicates a mandate meeting these criteria would easily withstand legal challenge.
Gail H. Javitt, JD, MPH, is a Of Counsel at DLA Piper. She has published and spoken widely on issues at the intersection of law and science, including FDA regulation of genetic testing, precision medicine, and next generation sequencing. Previously, Gail was law and policy director at the Genetics and Public Policy Center in Washington, DC. where she was responsible for developing policy options to guide the development and use of reproductive and other genetic technologies.
Flu kills 2,200 to 3,000 people a year in New York, especially the elderly. That is a major justification for mandating vaccines for schoolchildren. The vaccine is extremely safe and moderately effective in schoolchildren, who are the ones most likely to spread flu. The vaccine is less effective in those who need it most, the elderly and vulnerable. But vaccinating schoolchildren protects the old and vulnerable. You might have pointed to the solid evidence from Michigan, Ontario, and, especially, Japan that vaccinating schoolchildren protects them but also the elderly, for whom the vaccine is less effective.