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The U.S. Food and Drug Administration (FDA) unveiled plans today to limit approvals for updated COVID-19 vaccines to people over age 65 and people with one or more health conditions that put them at high risk for the virus.
The decision marks a shift in the agency’s approach to the shots, which were previously approved for all people ages 12 and older and, under emergency use authorization, for babies and children ages 6 months through 11 years.
Last week, The Wall Street Journal reported that the Centers for Disease Control and Prevention (CDC), which makes recommendations for FDA-approved medications, plans to stop recommending that pregnant women, children and teens routinely take the COVID-19 vaccine.
However, the new framework, outlined in an article published today in the New England Journal of Medicine (NEJM), does not completely take COVID-19 shots off the table for healthy people between the ages of 6 months and 64 years.
Instead, it requires vaccine makers to conduct randomized clinical trials that have clinical outcomes — preventing symptomatic COVID-19, hospitalization or death — on the drugs before the FDA will sign off on the vaccines.
When possible, the FDA will encourage vaccine makers to conduct randomized, controlled trials for healthy adults as part of post-marketing when it approves a COVID-19 vaccine for high-risk groups.
The CDC did not respond to The Defender’s inquiry about whether the agency still plans to announce revised recommendations in light of the FDA’s new policy, or whether it will remove the shots from the childhood immunization schedule.
No new trials needed for vaccines that target high-risk groups
Dr. Vinay Prasad, who earlier this month replaced Dr. Peter Marks as director of the FDA Center for Biologics Evaluation and Research (CBER), and FDA Commissioner Marty Makary — authors of today’s NEJM article — wrote that the U.S. COVID-19 vaccine policy has been “the most aggressive” compared to other high-income nations, which already confine the vaccination recommendations to these groups.
They said the benefit of repeat dosing, particularly among low-risk people who have had COVID-19 or been vaccinated, “is uncertain.” So they are rolling out a new “evidence-based” approach to the shots.
They also noted that annual uptake of the boosters has been low. Less than 25% of Americans received the boosters, ranging from less than 10% of children under 12 and 50% of adults over 75. Also, fewer than 1 in 6 healthcare workers have received a booster.
“Public trust in vaccination in general has declined,” they wrote, hypothesizing that COVID-19 vaccination policies have had a “ripple effect” on other vaccination programs. That includes the measles-mumps-rubella, or MMR vaccine, which they say is “clearly established as safe and highly effective.”
Under the new framework, shots for high-risk populations will continue to be approved based on immunogenicity — the ability to generate antibody titers — with no new trials needed.
100-200 million Americans still eligible for COVID shots under new framework
Prasad outlined the policy this afternoon in a “CBER Town Hall” on YouTube. After the presentation, Makary joined him for a more informal conversation that appeared geared toward making staunch vaccination supporters comfortable with the policy shift and assuring them that Prasad, an outspoken critic of the public health establishment, is well-qualified for his job.
Prasad said that under the new policy, between 100-200 million Americans would still be eligible for the shots. Others, he said, can participate in clinical trials.
The number is high because risk factors include depression, obesity and all immunocompromised conditions, he explained.
“The truth is that for many Americans, we simply do not know the answer to whether or not they should be getting the seventh, eighth or ninth booster as current policy would have us go down the road of,” Prasad said.
He also said there are important safety considerations and long-term consequences that remain unknown, though he did not elaborate on those.
Prasad also encouraged pharmaceutical companies to conduct clinical trials on groups for which there is “equipoise,” or genuine medical uncertainty, about the benefits of the vaccine — namely, people ages 50-64 and for very young children, ages 0-4.
FDA vaccine advisers to meet Thursday
The FDA’s vaccine advisory committee is set to meet Thursday to decide on the composition of the fall COVID-19 shots
In the post-presentation conversation with Makary, the two health officials emphasized the need to base approvals and recommendations on “gold-standard science.”
They also emphasized that Prasad is a “pro-vaccine person” and said the FDA plans to approve more vaccines in the future.
They suggested that mainstream media reports characterizing Prasad and others as “contrarian” for things like skepticism of boosters and other COVID-19 policies are out of line with true scientific consensus.
“Did RFK write your New England Journal of Medicine paper?” Makary asked Prasad.
“No, I actually have never even spoken to RFK, never met the man,” Prasad said. “You might be able to help me with that. I don’t know the guy. This was developed by me.”
Makary added that the shift was in line with U.S. Secretary of Health and Human Services Robert F. Kennedy Jr.’s “general instinct that we need more clinical trial data.”
Watch the ‘CBER Town Hall’ here:
Related articles in The Defender- Dr. Vinay Prasad Replaces Ousted Peter Marks as Chief FDA Vaccine Regulator
- FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process
- ‘Stunning Admissions’: White House Pressured FDA to Cut Corners on COVID Vaccine Approvals in Order to Push Mandates
- HHS Will Stop Recommending COVID Vaccines for Kids, Teens and Pregnant Women, WSJ Reports
