The FDA Will No Longer Routinely Approve COVID-19 Vaccinations for Healthy Individuals Under Age 65

The U.S. Food and Drug Administration (FDA) announced that it will no longer routinely approve COVID-19 vaccinations for healthy individuals under the age of 65. Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and Dr. Marty Makary, FDA director, co-wrote a paper for the New England Journal of Medicine and live-streamed a press conference to announce the new evidence-based framework for COVID-19 policy.

Prasad and Makary wrote, “Rates of hospitalization for COVID-19 among healthy children are considerably lower (approximately 20 to 30 per 100,000 children between the ages of 0 and 4 years) than rates among adults who are 65 to 74 years of age (approximately 150 per 100,000), suggesting that equipoise exists for studying the benefits and harms of vaccination in younger age groups.” During the press conference, Prasad said these numbers also include children who have risk factors, so the number for healthy children is likely lower.

The two FDA officials criticized the United States for adopting a one-size-fits-all approach to COVID-19 vaccine approvals. The U.S. has been an outlier in recommending the vaccine for healthy individuals of all age groups. The WHO issued guidance in August 2022 and wrote, “The direct health benefit of vaccinating healthy children and adolescents is lower compared with vaccinating older adults due to the lower incidence of severe COVID-19 and deaths in younger persons.”

The new regulatory framework from the FDA will now closely align with the U.K., Japan, Canada, Germany, and Australia. Three of these countries shifted their recommendations in March 2023 to only those 65 and older and those with risk factors.

“I think the most compelling information in the New England Journal paper is the vaccine COVID booster recommendation schedule in so many other countries in Europe and the world,” Dr. Makary said during the press conference. “And so it would almost seem as if the current U.S. strategy which is urging every single baby and teenager and child and healthy American and high-risk American encouraging every single one to get a booster every year. That is the outlier contrarian approach.”

This new regulatory approach only applies to new COVID-19 vaccines and has no impact on vaccines that are currently approved. There is a long list of risk factors for COVID-19, and newly approved vaccines will be available to individuals under 65 who have one of these risk factors. This includes women who are pregnant or recently pregnant.

Dr. Naomi Wolf appeared on The HighWire to discuss the potential harms for pregnant women who received the COVID-19 vaccination that were hidden from the Pfizer clinical trial data. V-safe data also collected reports of miscarriages and stillbirths for pregnant mothers who received the COVID-19 vaccine.

A preprint study published last month found decreased rates of “successful conception” (SC) in women who were vaccinated against COVID-19 before conceiving. The unvaccinated cohort in the Czech Republic had a mean of 3.1 SC per 1,000 women compared to 2.26 in the vaccinated group. This reflects a 27.1% reduction in successful conceptions for women who were vaccinated. This is a preprint paper that hasn’t yet been peer-reviewed. 

Dr. Prasad discussed the expansive list of risk categories that would include hundreds of millions of Americans, including physical inactivity.

“This is a tremendously broad category that effectively means 100 to 200 million Americans, those with the most favorable benefit to harm balance will be covered by such approvals,” Prasad said. “The CDC has a list of the conditions that qualify as high risk for severe COVID-19, and you can look at the list, and it’s in the paper. It’s a broad list, there’s a lot of things on this list; I’ll highlight a few. Obesity is on the list. Physical inactivity is on the list. Mood disorders, including depression, are on this list. And all immunocompromised conditions are on the list.”

The FDA is responsible for the approval of new vaccines, but the CDC is responsible for recommendations. This announcement means that new vaccines will not automatically be approved for healthy individuals of all age groups. Makary and Prasad wrote, “On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit-risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC.”

Makary and Prasad clarified that new COVID-19 vaccine approval for healthy individuals between the ages of six months and 65 years will require randomized clinical trial data. Specifically, the FDA is encouraging manufacturers to conduct randomized clinical trials on healthy individuals between the ages of 50 and 65.

The two FDA officials also clarified that studies on healthy individuals should involve a control group with an inert placebo, such as saline. “People who have had COVID-19 in the past year should not be excluded — since evidence is needed for the average American,” Makary and Prasad wrote. “Follow-up should extend for a minimum of 6 months to ensure that early booster gains persist.”

Earlier this month, HHS Spokesman Andrew Nixon said new vaccine approvals will require a clinical trial including a control group with an inert placebo. Aaron Siri, attorney for the Informed Consent Action Network (ICAN), wrote on his Substack, “Not a single routine childhood vaccine was licensed based on a long-term placebo-controlled trial. Not one.”

NPR quoted Dr. Paul Offit who responded to the news about placebo-controlled clinical trials as a requirement for vaccine approval. “I think it is the interest of Robert F. Kennedy Jr. to make vaccines more expensive, less available and more feared. He’s an anti-vaccine activist, a science denialist who is going to do everything he can to tear down the infrastructure in this country of vaccines. Robert F. Kennedy Jr is a dangerous man.”

In 2023, Siri and Offit had a debate via Twitter and Substack about using inert placebos for vaccine clinical trials. Many of the clinical trials contain an “immunologically-inert” placebo as Offit explains, but Siri clarifies that these are only useful for addressing efficacy and not safety.

Siri also said during “The Real Peter Marks” press conference that a common retort is that post-licensure data cannot be used to prove causality between the vaccine and serious side effects. Requiring saline-placebo clinical trials for new vaccines will provide more robust data regarding potential safety concerns.