OAN Staff Blake Wolf
1:29 PM – Tuesday, May 20, 2025
The U.S. Food and Drug Administration (FDA) announced that it will soon terminate automatic approvals for COVID-19 vaccines to low risk populations — such as children and adults who are deemed healthy by a doctor.
The policy change will also restrict access to newly developed COVID-19 vaccines to older adults and individuals with underlying health conditions.
In addition, it will revise the evidentiary standards that COVID-19 vaccines must meet before being broadly administered to children and healthy adults.
“Now, the FDA says companies must conduct clinical trials that show Covid vaccines are still safe and effective before approving them for healthy adults and kids,” DailyMail reported.
The new framework is outlined as:
“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,” read an article published by the New England Journal of Medicine.
“Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their post-marketing commitment,” the article continued
“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,” stated FDA Commissioner Marty Makary and Vinay Prasad, the director of the Center for Biologics Evaluation and Research.
The introduced change will move the United States’ policy on COVID-19 vaccinations closer to the kind of recommendations made in Canada, the United Kingdom, and Australia.
“The proposed policy moves the U.S. in line with other countries. This global view of public health is a welcome development,” stated Dr. Noel Brewer, a member of the CDC’s Advisory Committee on Immunization Practices.
FDA leaders will now require COVID-19 vaccine manufacturers to conduct “gold standard” clinical trials to compare the vaccine against placebos — prior to approving the vaccines for healthy individuals.
“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” Makary and Prasad continued.
Previously, the FDA automatically approved annual COVID-19 vaccinations for healthy young adults and children — marking a major shift in approach that will place the burden of showcasing the safety of the vaccines on pharmaceutical companies.
Nonetheless, officials also stated that the new policy will still allow any annual vaccinations to be available for Americans — if they so choose to get them.
“America is deeply divided on the policy of repeat COVID-19 vaccine doses or boosters… There are some Americans out there who are worried that the FDA has not fully documented and interrogated the safety harms of these products and they are categorically opposed to these products,” Prasad explained.
“There are also some Americans, we have to recognize, who are desperate for additional protections, and they demand these products,” he added. “But the truth is that most doctors, and most of the public, are entirely uncertain [about whether they need to get a COVID booster].”
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