FDA’s New COVID Vaccine Policy May Limit Who Gets New Shots. Here’s What To Know

Topline

The Food and Drug Administration announced Tuesday it is adopting a new regulatory framework for COVID-19 vaccines that will likely narrow recommendations for the vaccines to people over 65 and those at high risk for severe outcomes—a switch that could limit access to the vaccines to many others.

Adams 12 Five Star Schools District RN Tiffany Karschamroon draws a dose from a vial of the Johnson … More & Johnson COVID-19 vaccine on March 6, 2021 in Thornton, Colorado.

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Key Facts

FDA Commissioner Marty Makary and Vinay Prasad, the agency’s top vaccine regulator, said in an article published in the New England Journal of Medicine Tuesday the U.S. will no longer follow a “one-size-fits-all regulatory framework” on COVID-19 vaccines.

Makary and Prasad said the FDA expects it will be able to determine whether benefits outweigh risks for adults over 65 and people older than six months with high risk based on “immunogenicity,” or “proof that a vaccine can generate antibody titers in people.”

But for vaccines to receive a green light for the general public between six months and 64-years-old without health risks, the FDA will require “randomized, controlled trial data evaluating clinical outcomes” before a vaccine is approved.

The change will also more closely align the U.S.’ policy to that of other countries, including the United Kingdom, Canada and Australia, according to CNN.

Crucial Quote

“The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations,” the two FDA leaders wrote in the article, adding: “We reject this view.”

Key Background

In late 2020, the FDA gave emergency use authorization to two COVID-19 vaccines, one from Pfizer and one from Moderna, and they were recommended first to healthcare workers and people with high risk for severe cases. Initial vaccinations picked up speed in 2021 in an effort to gain herd immunity, and some boosters were recommended by the FDA under emergency use authorization for some people by September 2021. Boosters continue to be recommended, and the CDC recommends that everyone over six months of age—especially those over 65 and those at high risk of severe COVID—get the most recent shot. But data from late April shows that just 23% of adults and 13% of children are vaccinated with the most recent vaccine. In Tuesday’s article, Makary and Prasad wrote that while “the rapid development of multiple Covid-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment,” the benefit of boosters is “uncertain” and the American people are “unconvinced,” citing the low vaccination numbers.

Chief Critics

Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, expressed concern about the change to the Associated Press, saying: “Is the pharmacist going to determine if you’re in a high-risk group?” Offit added, “the only thing that can come of this will make vaccines less insurable and less available.” Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, told The New York Times, the change is “overly restrictive” and “doesn’t preserve people’s choice to get vaccinated.”

Contra

Daniel Salmon, director of the Institute for Vaccine Safety at Johns Hopkins Bloomberg School of Public Health, told Forbes in an email he thought the FDA’s approach announced Tuesday is “well calculated to license the vaccine for those at higher risk and to gain more information about the risks and benefits of the vaccine for lower risk persons through rigorous randomized controlled trials.” However, he said “looking for outcomes of hospitalization and death among lower risk persons will require very large trials” that may be difficult to get approved under current CDC recommendations.

How Have Vaccine Makers Responded?

Pfizer, which made the first vaccine approved by the FDA in 2020, said in a statement to Forbes it is evaluating the details from the FDA today and talks are ongoing. “We stand by the science behind the Pfizer-BioNTech COVID-19 vaccine and continue to believe that broad vaccination programs are an essential tool for helping to prevent COVID-19-associated hospitalizations and severe disease, including death,” the company said in the statement. Moderna, which made the second FDA-approved COVID-19 vaccine, said in a statement to Forbes: “We appreciate the FDA’s clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans.”

Big Number

25%. That’s around how many Americans received boosters each year over the last two years, according to data from the Centers for Disease Control and Prevention cited in Makary’s article.

Tangent

Prasad was named the head of the FDA’s Center for Biologics Evaluation & Research on May 6, making him the nation’s top vaccine, gene therapies and blood supply regulator. Makary praised him as bringing the “kind of scientific rigor, independence, and transparency we need” to the agency. Prasad was a vocal critic of the FDA before accepting the role, saying last year on a podcast with Vivek Ramaswamy he thinks the U.S. would “probably be better off as a result of not having the FDA” in its current state. He was also a critic of pandemic-era policies like school closures, mask mandates and COVID-19 booster shots before joining the FDA, CNN reported. He replaced Peter Marks, who had been the FDA’s vaccine chief for years but resigned in March after he clashed with Health and Human Services Secretary Robert F. Kennedy Jr. over his stances on vaccines, the Associated Press reported. Prasad has a background as a hematologist-oncologist who specializes in cancers of the blood, and he taught at the University of California at San Francisco.