“Why would a physician with a degree in public health make herself and her family guinea pigs?” Those at high risk will be offered the COVID-19 vaccine first. Once the vaccine becomes available to the general public, my family and I hope to be among the first on line to receive the COVID-19 vaccine. My friends are shocked that I would risk taking a vaccine that was developed at warp speed and lacks long-term safety and efficacy data. Here is what I tell them.
A vaccine will only halt the pandemic if the public embraces it. A recent Pew Foundation Survey indicates that only 51% of those surveyed are willing to be vaccinated (the remainder will decline). Of those who would get the vaccine, just 14% want to be among the first. I am in that minority.
The COVID-19 vaccine that receives FDA approval will undergo rigorous review during development. Scientific experts and governmental bodies will test its safety and efficacy. In the United States, data safety monitoring boards composed of independent experts committed to protecting the safety of participants and the integrity of the trials will evaluate the efficacy and risks of potential COVID-19 vaccines. When the review boards are convinced of a vaccine’s merit, the manufacturer will send it to the FDA. The FDA’s Vaccines and Related Biological Products Advisory Committee (also composed of independent experts committed to ensuring vaccine safety), will review the application, voice any concerns in public meetings, and make recommendations to the FDA. The CDC’s Advisory Committe on Immunization Practices, considered the standard for expert advice regarding vaccination, will establish guidelines for use of the vaccine. Other democratic countries have similar processes.
In addition to these safeguards to insure vaccine safety, additional measures will be implemented to further guarantee the safety of a COVID-19 vaccine. COVID-19 vaccine trials will enroll as many as 60,000 volunteers—more than ten-fold the number of subjects required for licensure of other vaccines—creating a massive database of information regarding the vaccine’s safety and efficacy and the statistical power to detect an adverse effect in 1 in 1,000, and perhaps even 1 in 10,000. The FDA has issued detailed guidance to manufacturers on the development of a COVID-19 vaccine requiring a two-month wait between the final testing and approval, to ensure safety and efficacy. As most adverse reactions occur within six weeks of vaccination, this two-month delay should screen for such events. The absence of adverse reactions will reassure the public.
The FDA has also committed to a minimum vaccine efficacy of 50%, comparable to the efficacy of the flu vaccine. Dr. Anthony Fauci, director of the National Institute of Allergy and Immunology and the leading expert in infectious disease in the United States, hopes for 75% efficacy. Last week, Pfizer announced preliminary findings of 90% efficacy. In an unprecedented effort to foster public trust, the vaccine manufacturers have publicly disclosed detailed information regarding vaccine protocols and temporary interruption of their trials due to adverse events. When the FDA approves the vaccine, New York, Rhode Island and Virginia will independently review the vaccine data before offering the vaccine to their residents. Dr. Fauci has stated that “ultimately, between the independent trial safety monitoring boards and the public advisory committee meetings, any kind of hanky-panky there that people are worried about is going to (go through) multiple checkpoints.” Scientists have called the COVID-19 vaccine the most heavily scrutinized vaccine in history.
As my friends point out, the vaccine cannot possibly have long-term safety data, but extensive review of vaccine studies indicates that long-term complications of vaccines are exceedingly uncommon. We continue to vaccinate because the benefits of vaccination far outweigh these remote risks. It is possible that a rare adverse effect could arise years after its approval. Dr. Paul Offit, director of the Vaccine Education Center and Infectious Disease at Children’s Hospital of Philadelphia and codeveloper of the rotavirus vaccine, explains, “You never know everything. The question is when do you know enough? With the information we have now, do the benefits outweigh the risks?” The relevant endorsements attest to the experts’ belief that the benefits outweigh the risks.
Jewish law also compels me to get vaccinated to protect myself and others from infection, to help create herd immunity, and to end the pandemic. Almost two hundred years ago, Tiferet Yisrael (Boaz, Yoma 8:3) permitted a healthy individual to be vaccinated against smallpox despite the vaccination’s 1 in 1,000 risk of death. Applying this criterion to COVID-19, Jewish law would certainly permit getting the FDA approved vaccine, which carries an even lower risk of death. Indeed, virtually all modern halachic decisors permit vaccination against childhood diseases; many even require it. The principles that establish a halachic obligation to vaccinate in general, apply to a COVID-19 vaccine. Failure to vaccinate violates several mitzvot including, “all Jews are responsible for each other,” “do not stand idly by,” and “do not place a stumbling block.”
Halachic sources require vaccination in the absence of a pandemic, when the risk of infection is low. During a pandemic, halachic decisors suggest that the obligation intensifies. They use the harshest terms to describe someone who refuses vaccination especially in a pandemic, classifying such an individual as negligent, a rotze’ah be-grama – indirect murderer, mazik (one who damages), a subcategory of gezel (theft) or shofech damim, murderer.” (For a more detailed discussion of how halacha approaches a COVID-19 vaccine, see my essay on the website of the journal Tradition: https://traditiononline.org/halakha-approaches-the-covid-19-vaccine)
“Why must you be first in line? Why not wait until there is long-term follow up data on the vaccines?” my friends ask. I answer that for every day we wait to confirm that the vaccines do not cause a very rare side effect, one-thousand people will die of COVID-19 in the US. For every six-months that the pandemic continues, 500,000 people will die of COVID-19 worldwide.
I pray for the speedy approval of an effective and safe COVID-19 vaccine to halt this pandemic. When the world achieves this milestone, I will be the first on line to get the vaccine, fulfilling my moral and religious obligation to protect myself, my children, and those around me from infection, to help us reach herd immunity, and to eradicate COVID-19. I hope that the line is long and that you will join me in this fight for humanity’s safety.