No Trial Data, No Vax: FDA Demands Gold Standard Testing For Any New COVID-19 Vaccines

Authored by Zachary Stieber via The Epoch Times (emphasis ours),

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.

“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: 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,” such as asthma or cancer, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, wrote in a New England Journal of Medicine article.

“For all healthy persons—those with no risk factors for severe Covid-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.”

Pfizer, Moderna, and Novavax, which have received licenses for their COVID-19 vaccines, did not immediately respond to requests for comment.

Several medical groups that have commented on FDA steps concerning COVID-19 vaccines, such as the American Academy of Family Physicians, did not return inquiries.

The FDA in 2024, in its most recent action concerning the Pfizer and Moderna vaccines, approved 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 approved 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 Tuesday. “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 past 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. recently pledged to require placebo-controlled trials for new vaccines.

Makary and Prasad planned to talk about the policy update at 1 p.m. on Tuesday.

This is a developing story that will be updated.