Especially since the advent of the COVID-19 Omicron variant, and the increasing incidence of infection and reinfection among those fully vaccinated and boosted, I have heard from a number of people whose concerns reflect the following sentiment, “You recommended the vaccine to prevent COVID-19, I took it, and this is what I got (infected).”
Undoubtedly, these COVID-19 vaccines are a gift of life, and continue to be safe and effective. Nonetheless, this sentiment is understandable, and in my assessment, it signals an urgent need for more precise labeling and messaging about the COVID-19 vaccines from the FDA.
On Dec. 10, 2020, at the invitation of the FDA, I gave a brief oral presentation at the open public session of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine. I ended my remarks as follows:
“In conclusion, the potential benefits of this vaccine outweigh the identified risks. Therefore, I support the issuance of an EUA with the stipulation that the vaccine can protect against symptomatic disease. But at this time it is not known if it prevents infection and transmission.”
The COVID-19 vaccine clinical trials and the resulting evidence show that the vaccines significantly reduce the risk of severe illness, hospitalization, and death. Nonetheless, in the labeling of the vaccines, and messaging to healthcare providers and the general public, the FDA specified that the Pfizer-BioNTech, Moderna, and Janssen vaccines are indicated for the “prevention of COVID-19” — this may have fostered an unrealistic expectation of absolute protection or immunity against COVID-19. By scientific convention, a vaccine is generally characterized as a primary prevention measure for a specific disease: that is, “you can be exposed to it without becoming infected.”
Over the summer, on Aug. 2, 2021, I emailed FDA’s Acting Commissioner Janet Woodcock, MD, regarding the word prevention, which the FDA has used to characterize the scope of protection provided by the three COVID-19 vaccines in use in the U.S. I noted that the word prevention in this context seems to be a misnomer, and can contribute to public confusion and vaccine hesitancy. In particular, in light of the increasing number of breakthrough cases, the public may be inclined to believe that the COVID-19 vaccines are losing effectiveness. I also urged the FDA to provide clarification to the public in this regard. Woodcock responded the same day as follows:
“Thank you for writing. We will take your suggestions into account. I agree that the expected results of vaccination are confusing for most people. It is very likely that vaccination prevents acquisition of infection in some people but not all vaccinated people and that some get symptomatic infection and rarely, severe disease, and this may be related in part to their overall immune system response, the variant they were exposed to, and the actual amount of exposure and the time since their last vaccination, among other things.”
Notably, in September 2021, the CDC tempered its definition of vaccination to reflect that vaccines produce “protection from a specific disease,” rather than “immunity to a specific disease.” (In either case, immunity was defined on the same CDC page as “protection from an infectious disease.”)
Woodcock’s response continues to reflect the performance of the COVID-19 vaccines. Prevention of COVID-19 is not the intended primary benefit of these vaccines. In fact, Woodcock and Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently made the point that most people will get COVID eventually. These vaccines continue to significantly reduce the risk of severe illness, hospitalization, and death — and that’s an amazing scientific feat amidst a deadly pandemic. Attention to timely and effective messaging to healthcare providers and the general public should be a top priority for the FDA. Semantics matter.
Rossi A. Hassad, PhD, MPH, is an epidemiologist and professor at Mercy College in Dobbs Ferry, New York. He is a Fellow of the American College of Epidemiology and a Chartered Statistician of the Royal Statistical Society in the U.K.
For all the latest Health News Click Here