Immunizations, in general, have become very controversial.

A 1998 study published in The Lancet suggested a link between the development of autism and bowel disorders in children and the measles, mumps, and rubella (MMR) vaccine.

This study has since been retracted by the journal, and the lead investigator, Andrew Wakefield, has had his medical license revoked.

Despite the link being proven false, many parents have chosen not to vaccinate their children for MMR after having heard about the study. This has led to fewer children being immunized and recent outbreaks of measles in the United States. In 2019, there were 1282 cases of measles in the country, the highest number since 1992.1 The vast majority of these cases were among people who were intentionally unvaccinated against MMR.1

HERD IMMUNITY
The principle of herd immunity is that when a large percentage of the community is immune to the disease, either by immunization or natural immunity, the spread of disease is limited. This protects unimmunized individuals indirectly, such as those who cannot be vaccinated or those with unsuccessful vaccination.

For some diseases, herd immunity may begin to be induced with as little as 40% of the population being immune either by vaccination or natural immunity, but the majority of diseases require an 80% to 95% immunity rate.2 This percentage is called the herd immunity threshold.2

STATE-MANDATED VACCINES
Questions often arise regarding the constitutionality or legality of state-mandated immunizations. Let’s start with the constitution. Amendment 14 to the Constitution of the United States asserts that no state shall make or enforce any law abridging the privileges or immunities of citizens of the United States or deprive any person of life, liberty, or property without due process of the law.3 Liberty for all will no longer exist if individuals are allowed to act without regard to the health and safety of others.

The federal government does not mandate immunizations. It is up to each state to determine the legality of a statute enacted to protect public health and safety. The Supreme Court of the United States has recognized each state’s “police power,” the authority to enact health laws such as quarantine and vaccination, to protect its citizens.

The Supreme Court has ruled that a state may mandate vaccines and accompany those mandates with a criminal fine for those who refuse. One of the first such cases was Jacobson v Massachusetts (197 US 11 [Massachusetts 1905]). The state mandated a vaccination for smallpox during an outbreak, with a $5 fine for all those who refused.4,5 The courts have consistently upheld this finding.

What happens if the state does not mandate a certain vaccine? Can an employer mandate vaccines? The answer is yes, if one is in the health care field, but probably no if not in the field. The Americans with Disabilities Act generally prohibits employers from mandating vaccinations unless they are job related and consistent with business necessity.6

WHAT TO EXPECT WITH COVID-19
In this era of the coronavirus disease 2019 (COVID-19) epidemic, questions are resurfacing regarding the validity of state-mandated immunizations. Given the political climate, this issue will be at the forefront when a vaccine does become available. Many Americans are going to resist getting vaccinated against the severe acute respiratory syndrome coronavirus 2 that causes COVID-19.

As scientists are moving quickly toward the development of a vaccine, now is the time to develop vaccination policies and programs. These will take time to finalize and enact.

It would be no surprise if all residents of hospitals, nursing homes, and so on, along with all health care workers, were mandatorily immunized. Ideally, all workers in direct-contact jobs would also be vaccinated. These would include barbers, flight attendants, grocery store and restaurant workers, hair stylists, nail techs, and teachers. This would reduce the spread of infection and the subsequent hospitalizations and deaths.

EXEMPTIONS
Every state in the United States has laws requiring children to be vaccinated against certain diseases before they can attend day care or school. However, parents can opt their children out of 1 or more of these vaccines for medical, religious, or personal reasons. Exemption laws vary from state to state, with some making it easier to obtain an exception than others.

Statistics show that the easier it is to obtain an exception, the more exceptions there are.

This results in more unvaccinated children and increases the risk of outbreaks of diseases, such as measles, mumps, and pertussis.7 The measles outbreaks of 2019 were among the worst in decades. Many of those who became sick lived in communities where there were groups of unvaccinated people.7

The goal of mandated immunizations is to protect children and communities from contagious diseases. Anti-vaccination groups have challenged mandated immunizations since they began in 1855.7 States must balance the need for public health against people’s rights to personal and religious beliefs.

There are 3 types of exemptions:
  • Medical: Individuals can obtain a medical exemption if a vaccine would not be safe for them. They may be immunocompromised, have a severe allergy to a vaccine or an ingredient in it, or they may have had a serious reaction to a vaccine in the past. To obtain a medical exemption, a clinician must sign an exemption form (some states use standard forms and some make their own). Many states will want to know if the exemption is permanent or temporary. Almost half of the states require a new form to be signed and submitted every year or so.7
  • Personal or philosophical: This exemption is based on personal beliefs about vaccines. Belief that the vaccines are unsafe, cause autism, or make people sick are some of the most common concerns.
  • Religious: This exemption allows people to opt out of vaccines based on religious beliefs. Of the major religions practiced in the United States, only some members of the Church of Christ, Scientist and the Dutch Reformed Church openly discourage vaccinations.8 Although some states require evidence of belonging to a church that objects to vaccinations, most simply have the patient or parent sign a form stating a religious reason to opt out.7 The figure9 on page 20 shows state-specific details on vaccine exemptions.

CONCLUSION
It is safe to say that mandated immunizations are controversial, but they are both constitutional and legal. States must do what is in their power to maintain public health and safety. On the other hand, individuals who cannot get vaccinated may have legitimate reasons for not doing so. A COVID-19 vaccine will present a new opportunity to resurrect the controversy of mandated immunizations. States will have to make many decisions, and create policies and procedures that will best use resources to combat COVID-19. 
 
Kathleen Kenny, PharmD, RPh, has more than 25 years of experience as a community pharmacist and is a freelance clinical medical writer based in Colorado Springs, Colorado.
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REFERENCES
  1. Measles cases and outbreaks. Centers for Disease Control and Prevention. Updated June 9, 2020. Accessed July 23, 2020. https://www.cdc.gov/measles/cases-outbreaks. html
  2. Herd immunity and COVID-19 (coronavirus): what you need to know. Mayo Clinic. June 6, 2020. Accessed July 23, 2020. https://www.mayoclinic.org/diseases- conditions/coronavirus/in-depth/herd-immunity-and-coronavirus/art-20486808
  3. All amendments to the United States Constitution. University of Minnesota Human Rights Library. Accessed July 23, 2020. http://hrlibrary.umn.edu/education/all_ amendments_usconst.htm
  4. Najera RF. What the Supreme Court has said about mandating vaccines for school: Jacobson v. Massachusetts. The History of Vaccines. March 5, 2019. Accessed July 23, 2020. https://www.historyofvaccines.org/content/blog/jacobson-v-massachusetts-reiss
  5. Fujiwara S. Is mandatory vaccination legal in time of epidemic? Virtual Mentor. 2006;8(4):227-229. doi:10.1001/virtualmentor.2006.8.4.hlaw1-0604
  6. Sues AP. Navigating the legal risks of a mandatory vaccine program for employees. Labor and Employment Law Update. November 12, 2019. Accessed July 23, 2020. https://laborandemploymentlawupdate.com/2019/11/12/navigating-the-legal- risks-of-a-mandatory-vaccine-program-for-employees/
  7. States with religious and philosophical exemptions from school immunization requirements. National Conference of State Legislatures. June 26, 2020. Accessed July 23, 2020. https://www.ncsl.org/research/health/school-immunizationexemption-state-laws.aspx
  8. Najera R. Very few religions expressly prohibit vaccination, yet confusion remains. The History of Vaccines. November 9, 2019. Accessed June 18, 2020. https://www. historyofvaccines.org/content/blog/religion-vaccination-confusion
  9. State school and childcare vaccination laws. Centers for Disease Control and Prevention. Updated April 28, 2017. Accessed July 23, 2020. https://www.cdc.gov/phlp/ publications/topic/vaccinations.html