Following the Food and Drug Administration’s (FDA) approval of the Pfizer-BioNtech vaccine (Comirnaty) for COVID-19, more Americans are lining up to receive the vaccine. In the week following Pfizer’s full approval, the country saw a 17% increase in the number of Americans getting vaccinated with their first dose.ⁱ

With the Pfizer approval a reality, a number of public and private organizations are discussing whether to mandate vaccination. Let’s take a look at the history around vaccine mandates and their impact on public health.

A Brief History of Vaccines and Their Impact on Public Health

Vaccines have profoundly impacted public health, and in many cases have eradicated several infectious diseases, including smallpox and polio. Most of these infectious diseases historically have had a high incidence in school-aged children because of the high potential for transmission.

School vaccination laws have played a key role in controlling vaccine preventable diseases in the United States. The first school vaccination requirement was enacted in the 1850s in Massachusetts to prevent smallpox transmission in schools. ⁱⁱ By 1963, 20 states, the District of Columbia, and Puerto Rico had such laws, mandating a variety of vaccines.ⁱⁱⁱ

In the United States today, we vaccinate infants and young children against a dozen pathogens, including diphtheria, Haemophilus influenzae type b, hepatitis B, measles, mumps, pertussis, poliomyelitis, rotavirus, rubella, Streptococcus pneumoniae, polio, influenza, tetanus, and varicella. In states with high risk for hepatitis A, children are also vaccinated against this disease. ^iv

In the mid-1980s, the United States experienced a decline in vaccine manufacture capacity due to liability costs, which in turn led to passage of the National Childhood Vaccine Injury Act (NCVIA) in 1986. This law led to a modernization of vaccine programs under the auspices of the United States Department of Health and Human Services.

Vaccine Risks

As with any medication, vaccines are not without risk to the patient. However, unlike other medications, vaccines are generally given to healthy individuals. The benefits of vaccination may extend far beyond the individual by significantly serving public health by accelerating herd immunity. To track the potential risk of vaccines, the following systems are in place:

• Vaccine Adverse Event Reporting System (VAERS) – Requires reporting of adverse events by vaccination providers (42 U.S.C. § 300aa-25).
• Providers must record lot numbers of vaccines administered; furthermore, various federal agencies, including the Centers for Disease Control’s (CDC) National Immunization Program, have expanded vaccine-safety activities.

These systems have resulted in diminished liability costs related to vaccines, prompting a revised claim process, allowing more manufacturers entering vaccine production, and development of new vaccines against other diseases.

Considerations for Mandates

With this history in mind, how does a public or private organization go about considering mandating vaccines? Reviewing information from key stakeholders and experts is a critical starting point.

Federal and State Laws

The Department of Justice (DOJ) and the Equal Employment Opportunity Commission (EEOC) have ruled that businesses may lawfully require workers to get a COVID-19 vaccine, even under emergency use authorization (EUA), as a condition of coming to the workplace. However, businesses must grant legitimate medical or religious exemptions.

The private sector has wide discretion in setting conditions for workers and customers, and businesses have a legal and ethical duty to keep the workplace safe.

States have long had the constitutional authority to mandate vaccinations, which the Supreme Court has upheld twice, first in 1905 ^v and then in 1922.^vi To date, all state government mandates have been for fully approved vaccines.

Benefit Versus Risk

The Board of Directors/C-Suite/Decision Makers of a business or health system need to know the facts to date regarding vaccine benefits versus the risks. A review of data shows that in the case of COVID-19 within the United States, the vaccine benefit outweighs the risk:

• COVID-19 United States deaths have reached nearly 632,000 with hospitalizations approaching 2.7 million ^vii
• Among the more than 172 million in the United States who are vaccinated, approximately 10,000 had breakthrough infections and were hospitalized ^viii

To date, no unexpected patterns have been identified in the case demographics or vaccine characteristics among people with reported vaccine breakthrough infections, but continued transmission of COVID-19 imposes a huge burden on resources and capacity.

The Pharmacy Point of View

The American Society of Health-System Pharmacists (ASHP) Joint Statement ^ix supports COVID-19 vaccine mandates for all workers in health and long-term care facilities. The American Hospital Association (AHA) has also issued a policy statement ^x that outlines key points in support of mandates, concluding that COVID-19 vaccinations are safe and effective at reducing both the risk of becoming infected and the risk of spreading the infection to others.

Examine Exemptions to a Potential Mandate

Under federal law, people have a right to seek medical and/or religious exemptions to a vaccine mandate. When identifying possible exemptions to a vaccine mandate, it will be important to involve the hospital’s ethics committee, Human Resources, and any other appropriate stakeholders such as the legal team in formulating a plan for exemptions. Legitimate exemptions should be outlined in a policy document and may include allergies to a component within the vaccine.

The Advisory Committee on Immunization Practices (ACIP) recommends the following guidance: ^XI

• No vaccine preference for those with the following underlying conditions:
  • Immunocompromising conditions or people who take immunosuppressive medication or therapies
  • Autoimmune conditions
  • A history of Guillain-Barré syndrome
  • A history of Bell’s palsy
  • A history of dermal filler use
• Immunocompromised persons can receive any currently authorized COVID-19 vaccine
• Pregnant and lactating women can receive any currently authorized COVID-19 vaccine
• Previously or currently infected persons can receive any currently authorized COVID-19 vaccine
• Persons who received antibody treatment are advised to defer vaccination for 90 days
• Persons with MIS-A or MIS-C are advised to defer vaccination for 90 days
• Persons who received IVIG antibody therapies not specific to COVID-19 treatment can receive the vaccine
• Persons with acute shingles or other illness are advised to delay vaccination until the acute illness has improved; however, if the potential benefits of vaccination outweigh the potential risks, they may receive the COVID-19 vaccine

Employers providing vaccination to workers should keep a record of the offer to vaccinate and the employee’s decision to accept or decline vaccination. Employers should allow for time off for employees to get the vaccination as well as post-vaccination in the event that the employee experiences a reaction.

Instilling Vaccine Confidence

Some employees may ask for exemption based on their lack of confidence in the vaccine. The CDC has developed a vaccine communication and confidence checklist to help organizations instill confidence in the vaccine among their employees.^xii

It is important to communicate clearly that the COVID-19 vaccines are safe, effective, and are the strongest strategy we have to date. Vaccination should be part of a “layered risk mitigation strategy” that includes masking, distancing, and sanitizing/regular hand washing.

Conclusions

The goal of vaccines is to limit the severity of disease and reduce hospitalization and deaths. Each variant poses additional dangers to increased transmission as the virus mutates, making vaccination essential to reducing the opportunity for vaccine-resistant variants to develop. To date, the FDA has approved one vaccine (Pfizer) with another (Moderna) on its heels. The CDC recommends that everyone 12 years of age and older get a COVID-19 vaccine as soon as they can. The CDC anticipates that vaccine guidance for those younger than 12 will be available for review in the next 30 to 60 days.

Those who are fully vaccinated and get infected (i.e., “breakthrough infections”) pose a risk of transmission to others. For this reason, anyone who lives in an area with high transmission of COVID-19 is better protected by wearing a mask in indoor public places, socially distancing, and using universal precautions.

People who are immunocompromised may not be protected even if fully vaccinated and may be more likely to have a breakthrough infection. These individuals should continue to take all precautions recommended for unvaccinated people until advised otherwise by their healthcare provider.

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