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December 29, 2020

Mandating COVID-19 Vaccines

Author Affiliations
  • 1O’Neill Institute for National and Global Health Law, Georgetown University, Washington, DC
  • 2Institute for Vaccine Safety, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
  • 3London School of Hygiene & Tropical Medicine, London, United Kingdom
JAMA. Published online December 29, 2020. doi:10.1001/jama.2020.26553

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life. The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for 2 messenger RNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data for the vaccines granted an EUA reportedly demonstrate 95% efficacy, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1676 adults surveyed November 30 to December 8, 2020, found that when a COVID-19 vaccine is approved and widely available: 34% would get it as soon as possible; 39% would wait; 9% would only get it if required for work or school; 15% would definitely not get it. Black persons, at high risk of infection and hospitalization, are less likely to report vaccine intent with only 20% reporting they would get the vaccine soon and 52% intending to wait.1 Intent to vaccinate has changed substantially over time and is likely to continue to evolve. In this Viewpoint, we examine whether vaccine mandates would be lawful and ethical and whether they could boost vaccine uptake.

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    4 Comments for this article
    Mandating Covid-19 Vaccination
    Kent Savage, MHA | Retired Healthcare Executive
    In a freedom-based society such as the United States of America (USA), mandating vaccinations of any kind is contraindicated. Why would a healthcare professional ever suggest such a thing? It is because of the politicization of the pandemic in our American culture. We can attribute this to a President who has created more controversy over the pandemic than Woodrow Wilson who downplayed the 1918 influenza pandemic. The current President, like President Wilson with influenza, downplayed Covid-19 and then became sick with the virus. The difference is that the current President recovered rather quickly apparently causing him to believe Covid-19 was relatively benign unlike Mr. Wilson who became violently ill for some time.

    What does this have to do with vaccinations today? The President and his followers tend to believe him without question so about 48% of the population believe Covid-19 is predominantly benign. How could any reasonable healthcare professional believe that mandated vaccination would even begin to be successful in a reasonable timeframe when 48% of Americans will likely refuse to take it? Even if the refusal was near 25%, the intended result would not occur in a suitable timeframe.

    The best way to ensure maximum vaccination exposure is through public discussion that convinces the 48% that while the President may have had minimal health issues from Covid-19 a large number of people do and could easily include you, your children, your parents and your grandparents. We need continued examples of the safety of the vaccination and to have the reactions so closely reported in the press to be put into context.

    For example, 3 out of even 100,000 people having side effects makes the probability of having side effects almost non-existent while having 90,000 or so out of 100,000 develop immunity a significant goal attainment in eradicating this pandemic. We also need every healthcare worker and healthcare organization to demonstrate ZERO defects in administering the vaccine so that we stop hearing about those who were overdosed.

    Demonstrating, very directly, how the benefits outweigh the risks of vaccination by roughly 30,000:1 is a compelling argument for voluntarily receiving the vaccine. Other methods to improve voluntary vaccination include making it simple: minimal health history prior to vaccination (only information that is relevant to known allergies, etc.), large choice of vaccination locations, requiring all insurers to cover the 100% of the cost without unending documentation (yes, it's apparently free except to those with insurance), no requirement of a licensed provider's order, and the choice as to whether to get it or not.

    This is how we vaccinate the greatest percentage of people: "keep it simple." Free will is an inherent right of all mankind. Gentle, persistent and encouraging rhetoric helps people make the right choice, not mandates. I am not impressed with medical proselytizing nor with believing our healthcare system is always working in the best interests of society (a topic for another time). Consider the nature of flawed human decision-making. My grandfather had a very appropriate saying for this situation: "you can bring a horse to water but you can't make it drink." Mandates will not work in our current social environment. Find another, more appropriate approach.
    Expectations and Anxieties About the COVID-19 Vaccine in Japan
    Takuma Hayashi, MBBS, D.M.Sci., GMRC, PhD | National Hospital Organization Kyoto Medical Center
    In Europe and the United States, vaccination against COVID-19 began in early December 2020. In Japan as well the start of vaccination against COVID-19 is expected. The Japanese Society of Infectious Diseases provides medical information to the Japanese people regarding the efficacy and safety of the COVID-19 vaccines which are currently being used overseas. In order for the Japanese people to judge the necessity of COVID-19 vaccination, the Japanese Society for Infectious Diseases on December 28 posted a proposal (1st edition) on their website. In the future, the content of the proposal regarding the COVID-19 vaccine will be updated from time to time as the situation of the COVID-19 vaccine changes in Japan and overseas.

    The proposal (1st edition) comprises sections on
    • Status of COVID-19 vaccine development worldwide
    • Medical features of each COVID-19 vaccine
    • Mechanism of action of mRNA vaccines and viral vector vaccines
    • How to evaluate the efficacy of COVID-19 vaccine
    • Efficacy in clinical trials of three vaccines (Pfizer's BNT162b2, Moderna's mRNA-1273, AstraZeneca's ChAdOx1)
    • Adverse events after the first and second vaccinations
    • Priority vaccination target in Japan
    • Precautions for COVID-19 vaccination
    In recent years the Japanese people have developed a negative attitude about vaccination. In Japan, in comparison with other countries, a special situation is continuing in relation to HPV vaccination. Serious symptoms have been observed after vaccination with the HPV vaccine, and the causal relationship between HPV vaccination and the serious symptoms continues to be disputed in Japan. Due to this dispute, many Japanese people do not accept HPV vaccination. From that experience, the number of Japanese people who wish to receive the COVID-19 vaccine is about 60% of all Japanese people, even if the COVID-19 infection continues to spread. In order for many Japanese peoples to be vaccinated with the COVID-19 vaccine, the Japanese government must transparently publicize any causal relationship between vaccination and adverse events and enhance medical support for serious medical conditions.
    EUA Standards are not less than normal BLA
    Eric Harris, PhD | Retired neuroscientist
    Gostin et al. state that "an EUA requires less safety and efficacy data than full Biologics License Application (BLA) approval." Are there FDA regulations or guidances that support that statement? FDA's Q&A about COVID-19 vaccines state the following: "COVID-19 vaccines are undergoing a rigorous development process that includes tens of thousands of study participants to generate the needed non-clinical, clinical, and manufacturing data. FDA will undertake a comprehensive evaluation of this information submitted by a vaccine manufacturer."
    Mandatory Coronavirus Vaccinations
    Andrea Gardner, Registered Nurse | Retired
    This isn't a political issue. Vaccine-hesitant individuals come from all walks of life. Some believe all vaccinations are harmful. Others are skeptical because of past harmful actions, and will carry those ideas with them for this vaccine. Those harmed by a pharmaceutical such as diethylstilbestrol might think that until something is proven to be both safe and effective they might wait for more data to come forth prior to getting theirs.

    These vaccines are brand new. In reality we know very little about them. They received EUA only; they are not licensed. I am very uncomfortable
    with Dr. Fauci's recent suggestion that he might advise getting more people vaccinated once but holding off on the second dose. We don't really know how well the vaccines work with the two vaccinations given on time. If I can't get them as directed by the manufacturer, I will wait until I can. There's too much at stake. We don't even know how long any protection will last.

    Let's encourage the public to be vaccinated. Many groups are anxious for the vaccine to be available to them as soon as possible. My daughter in law, who is a nurse, was among the first in her hospital be vaccinated, having signed up prior to EUA approval. Most of my friends and former colleagues are waiting for their chance to get it. We older folks who are in good health lead busy, active, lives. I want to have my grandchildren back in my home. I want to return to my civic and social activities, and travel. Politics doesn't enter into my decision. Let's not malign a group with which we don't agree; that won't help anything.