FDA Announces ‘Radical Framework’ for Overhauling Vaccine Approval Process

The U.S. Food and Drug Administration (FDA) is preparing to issue new guidance for vaccine manufacturers in the coming days as part of a new “radical framework.” The guidance will likely focus on the COVID-19 shots, The Washington Post reported Thursday, citing comments by FDA Commissioner Marty Makary earlier this week.

The Post published its story earlier Thursday, before The Wall Street Journal reported that unnamed sources at the U.S. Department of Health and Human Services (HHS) said HHS is expected to announce within days that it will no longer recommend COVID-19 shots for children, teens and pregnant women.

Speaking at the Food & Drug Law Institute’s conference in Washington, Makary gave few specifics about the upcoming new framework but said it will help ensure the pharmaceutical industry understands “exactly what we’re thinking,” Endpoints News reported.

According to the Post, this may entail “guidance to companies so that they know the agency’s approach to vaccine approvals.”

“We want to be very transparent, and we want to create a framework for vaccine makers that they can use so they have a predictable FDA where they don’t have to worry, ‘How is this going to be received?’” Makary said at the conference.

The announcement comes just a month before government regulators are set to review COVID-19 vaccines for the next cold and flu season.

James Lyon-Weiler, Ph.D., president and CEO of the Institute for Pure and Applied Knowledge and editor-in-chief of the journal Science, Public Health Policy & the Law, said the new framework is “long overdue” and “may represent an inflection point — if it goes beyond mere optics and addresses the core systemic failures that have plagued vaccine policy for decades.”

Lyons-Weiler said:

“For decades, vaccine licensure has operated on a foundation riddled with shortcuts. What we need now is a true break from the past — a regulatory framework grounded in the principles of precision public health, stratified risk, and individualized safety.”

Makary said Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research (CBER) — which oversees the approval and regulation of vaccines, gene therapies and other biologic drugs — will oversee the new framework and has been meeting with industry representatives and FDA staff.

Makary said he and Prasad believe “in gold standard science and common sense, especially when it comes to rare diseases,” Endpoints News reported.

Kim Witczak, a drug safety advocate who has worked with the FDA as a consumer representative, said the proposed framework is “encouraging.”

Witczak said:

“Vaccine oversight has operated under a patchwork system without transparency, from placebo discussion to lack of discussion around safety.

“The fact that this is even being acknowledged is a major step forward, but the real test will be in the details. We’ve seen too many promises of FDA reform that end up being more about optics than substance.”

Makary questions COVID vaccine approval process

According to the Post, the FDA’s announcement comes amid “uncertainty” that the first Trump administration introduced “into the annual process for green-lighting updated coronavirus shots traditionally offered in the fall.”

Speaking at the conference, Makary questioned the continued approval of COVID-19 vaccines based on years-old clinical trial data.

“Should we be making recommendations based on a randomized trial that’s three or four years old with the new variant and a delta in population immunity?” Makary asked reporters. “So a lot of those original randomized trials were done at a time when there was very low population immunity.”

Karl Jablonowski, Ph.D., senior research scientist at Children’s Health Defense, said “a new randomized trial on the COVID-19 vaccines would be a death blow to their EUA status” — referring to the emergency use authorization (EUA) under which they were released and through which they continue to enjoy a federal liability shield.

Jablonowski cited a presentation delivered during the October 2024 meeting of the CDC’s Advisory Committee on Immunization Practices (ACIP), which stated that the long-term efficacy of the COVID-19 vaccines was statistically negative for adults 18-64 years old.

Linda Simoni-Wastila, Ph.D., a professor at the University of Maryland School of Pharmacy, said a re-examination of the COVID-19 shots may also include “reassessment of whether use of mRNA and other platforms constitute gene therapeutics as opposed to vaccine therapeutics.”

“Products developed using mRNA as a platform are different than vaccines developed using traditional, non-mRNA platforms — and thus, should have different guidance and thresholds for market approval,” Simoni-Wastila said.

Simoni-Wastila also called for the elimination of vaccine manufacturers’ liability shield and more “research on so-called ‘inert’ and ‘adjuvant’ materials added to vaccines.”

At the conference, Makary expressed support for “good science” and “some good clinical data” in the vaccine approval process, adding that the process should be tailored “to the condition being treated” and should include better safety surveillance.

“Is there a safety signal we didn’t see in the trial, and is there a benefit that we didn’t see in the trial?” Makary asked. “We should also be looking at post-approval monitoring about what’s actually going on.”

Witczak said she expects the framework to “emphasize transparency, independent data review, and a slowing of the accelerated approval pathways — especially EUA mechanisms that bypass traditional safety guardrails.” She said this “could signal a shift away from the ‘warp speed‘ mentality and toward restoring public confidence.”

Lyons-Weiler suggested the framework include mandatory long-term follow-up of vaccine-related adverse events, a requirement for placebo-controlled clinical trials and pre-vaccination risk screening, establishing regulatory independence, revisiting existing vaccine recommendations, and establishing data transparency.

Earlier this month, Makary announced the development of a new real-time surveillance system to capture data on vaccine injuries. At the conference, Makary said this database will help support the new vaccine framework.

“Νow with big data, we are assembling some of the biggest electronic health record databases, and we will be able to query those databases in real time as soon as we approve a drug,” Makary said.

Big Pharma has been jittery about the new administration’s vaccine approval process plans. Biopharma stocks dropped when Prasad was named director of CBER earlier this month — and when his predecessor, Peter Marks, M.D., Ph.D., widely viewed as being industry-friendly, resigned in March.

According to Endpoints News, Makary responded to these concerns, saying “we do want to get decisions to sponsors quickly” and suggesting that the approval process could be made more efficient.

Prasad had previously criticized public health agencies — and Marks — for what he described as a lax approval process for vaccines. In a post on X in March, Prasad said Marks could be replaced “with a bobblehead doll that just stamps approval and you would have the same outcome.”

Public trust has been broken

According to Endpoints, Makary’s announcement reflects “the latest in a series of changes the administration is considering on the vaccine front,” including changes in how vaccine trials are conducted and increased scrutiny of existing vaccines.

Last month, HHS announced that all new vaccines will have to be tested against a placebo before they can be approved, in what the department described as “a radical departure from past practices.”

Also last month, HHS suggested the COVID-19 vaccines could be removed from the childhood immunization schedule — a proposal that was then made at the April meeting of ACIP, despite pushback by some of the committee’s members.

According to the Post, ACIP will vote on recommendations for fall COVID-19 vaccines at its June 25 meeting.

The FDA recently asked Novavax, which sought full approval of its COVID-19 vaccine, to commit to performing a new clinical trial after its vaccine gets approved.

According to The Associated Press, the FDA’s increased scrutiny of the Novavax COVID-19 vaccine “is sowing uncertainty about updates to other vaccines, too.”

Earlier this month, HHS and the National Institutes of Health (NIH) announced that the Trump administration will invest $500 million into research on vaccines that protect against multiple strains of “pandemic-prone viruses,” as part of a program that will be known as Generation Gold Standard.

Simoni-Wastila suggested that possible interactions between vaccinations frequently administered together, such as those on the childhood schedule, warrant more research and should be included in the new framework.

“At present, there is no agency that is equipped and required to do such analyses,” she said. “The FDA could contribute to this vital need by requiring new applications to conduct, at the least, post-marketing analyses.”

Witczak said public trust in government health agencies has been broken, and that the new framework can help restore it.

“If we want to restore faith in the system, we must be willing to look at the process with clear eyes and the courage to make meaningful changes. After all, these are products being injected into our bodies — safety, transparency, and choice must come first,” Witczak said.

“We cannot allow this moment to become another missed opportunity,” Lyons-Weiler said. “The public deserves an FDA that puts safety science ahead of market speed and that is transparent and humble enough to acknowledge past errors.”