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The Food and Drug Administration (FDA) will not approve COVID-19 vaccines for many Americans absent trial data showing that the benefits outweigh the risks, top agency officials said on May 20.

FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA's Center for Biologics Evaluation and Research, said that the FDA's new COVID-19 vaccine framework will have two tiers. For people aged 65 or older, and for people who have a risk factor that places them at high risk for severe COVID-19 outcomes, manufacturers will only need to provide proof that a vaccine can trigger antibodies. For everyone else, or those without risk factors, the FDA is requiring data from randomized, controlled trials showing that a vaccine prevents symptomatic COVID-19 and secondary outcomes such as death.

"The FDA can only approve products if it concludes, based on scientific evidence, the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease," Prasad <a href="https://www.youtube.com/watch?v=jbRGlEsbKQ4">said</a> in prepared remarks from the FDA's headquarters in Maryland on May 20.

The trials will not be required every year, but likely every few years, he stated.

Some 100 million to 200 million Americans fall under the first tier, the officials <a href="https://www.nejm.org/doi/full/10.1056/NEJMsb2506929">estimated</a> in the New England Journal of Medicine article.

"At last, FDA is recognizing the need for 'evidence-based medicine' and controlled trials to support the concept of boosters without end," Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, told The Epoch Times via email.

A Novavax spokesperson declined to comment. Pfizer and Moderna did not return inquiries.

The American Academy of Pediatrics and American Academy of Family Physicians did not respond to requests for comment.

The FDA in 2024, in its most recent action concerning the Pfizer and Moderna vaccines, <a href="https://www.theepochtimes.com/health/fda-approves-new-covid-19-vaccines-5710997">approved</a> updated versions for most Americans and extended emergency authorization for others, despite there being no trial data available for those formulations.

The regulatory agency on May 16<a href="https://www.theepochtimes.com/health/fda-approves-new-covid-19-vaccine-with-restrictions-5859587"> approved</a> Novavax's COVID-19 vaccine for the first time. The approval was for adults aged 65 and up. The agency said that people aged 12 to 64 could receive a Novavax shot, but only if they have one of the conditions that puts them at higher risk for severe COVID-19 outcomes.

An earlier version of Novavax's shot was tested in a randomized, controlled trial in 2021.

The Centers for Disease Control and Prevention currently recommends that people aged 6 months and older receive one of the latest COVID-19 vaccines, but just 13 percent of children and 23 percent of adults have followed that recommendation.

Makary and Prasad noted that a number of other countries, such as Australia and Germany, only recommend COVID-19 vaccines to certain populations.

"While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months," they wrote on May 20. "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. We reject this view."

The officials said that while the quick development of COVID-19 vaccines was a scientific and medical achievement, the benefit of repeated dosing—some people have received at least six doses—is unclear.

The trials of the vaccines should measure prevention of symptomatic COVID-19, with secondary endpoints including severe COVID-19, hospitalization, and death, according to Makary and Prasad, who said that the trials should include participants who contracted COVID-19 within the preceding year, and they should follow participants for at least six months "to ensure that early booster gains persist." The control group could receive a saline placebo, the officials said.

"Ultimately, these studies alone can provide reassurance that the American repeat-boosters in-perpetuity strategy is evidence-based," they wrote.

Health Secretary Robert F. Kennedy Jr. on April 30 <a href="https://www.theepochtimes.com/article/hhs-to-require-placebo-controlled-trials-for-new-vaccines-5850077">pledged</a> to require placebo-controlled trials for new vaccines.

Orient said that the FDA should have previously provided details on the safety risks associated with the vaccines.

The FDA has been referring requests for comment to the Department of Health and Human Services. A spokesperson for the department told The Epoch Times in an email that the current vaccine safety systems don’t work well and that the department is building better ones.

<em>From <a href="https://www.theepochtimes.com/health/fda-says-no-licenses-for-covid-19-vaccines-for-many-americans-without-trial-data-5860572">The Epoch Times</a></em>

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Zachary Stieber is a senior reporter for The Epoch Times based in Maryland. He covers U.S. and world news. Contact Zachary at zack.stieber@epochtimes.com

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FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data