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US FDA wants expert input on COVID-19 vaccines but keeps mum on range of advice


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US FDA wants expert input on COVID-19 vaccines but keeps mum on range of advice

At a much-anticipated meeting, the U.S. Food and Drug Administration wants a panel of experts to weigh in on COVID-19 vaccines but has not revealed the specific questions it wants the committee to answer.

The Oct. 22 online forum will not be a typical FDA advisory committee meeting, where data about the safety and efficacy of specific products are vetted.

Rather, the FDA's Vaccines and Related Biological Products Advisory Committee will be mulling over broad questions about the development, authorization and licensure of COVID-19 vaccines — products that may be available as early as late November or early December, though initially in limited supply and for only certain populations.

FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research Director Peter Marks have pledged to hold future advisory committee meetings to examine specific COVID-19 vaccine marketing applications before the agency grants either emergency use authorization, or EUA, or full licensure.

Pfizer Inc. and Moderna Inc. may be the likely candidates to first get those advisory committee meetings, with both companies stating that they anticipate having phase 3 data in mid-to-late November and may seek EUAs if the trial results are positive.

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Peter Marks, director of FDA's Center for Biologics Evaluation and Research
Source: U.S. Food and Drug Administration

But the expert panel at the Oct. 22 meeting — which will be broadcast on the FDA's website and YouTube — are expected to only discuss and recommend generally what types of studies should be required for determining the safety and efficacy of COVID-19 vaccines, the products' abilities to provoke an immune response and their duration of effectiveness.

The committee is also expected to be asked to debate the need for postmarketing safety studies for any COVID-19 vaccines that are licensed in the U.S. In addition, the FDA wants its outside advisers to deliberate over what may be needed to track the safety and assess the benefits and risks of COVID-19 vaccines that are granted an EUA.

But the FDA has yet to make public the full range of questions regulators may ask the advisers. A draft agenda posted Oct. 20 on the FDA's website shows the regulator plans for most of the meeting to consist of presentations by the agency and other government officials, including from the U.S. Centers for Disease Control and Prevention and the National Institutes of Health.

The FDA is providing about two hours for the committee to discuss that information and make recommendations. The agency will also allow 90 minutes for the panel to hear from the public.

The committee consists of experts in immunology, molecular biology, virology, bacteriology, epidemiology and biostatistics. FDA's Marks noted in an Oct. 20 podcast that regulators added temporary advisers to the panel with specific expertise in COVID-19 and other coronaviruses.

The committee's current chairwoman is recusing herself from participating at the meeting, as are about a half dozen other members, because they or their organizations have some ties to the companies developing COVID-19 vaccines.

The committee members are vetted to make sure they do not have any conflicts of interest with any of the matters that are under discussion, Marks noted. However, at least two of the panelists received waivers after the FDA said their "participation outweighs any potential conflict due to the financial interest."

Unblinding studies

The U.S. regulator has already received comments from the public and industry about how the agency should approach granting an EUA or licensure to COVID-19 vaccines.

Pfizer told the FDA that while clinical trials should remain blinded as long as possible, the company believes it has an ethical responsibility to inform all study participants about the availability of an EUA if one is granted and the eligibility requirements to receive the product.

If Pfizer's vaccine gains the EUA status, the company said it would propose amending its ongoing study to allow cross-over of eligible placebo participants to the active vaccine arm if they wish to do so at any time.

"The statistical considerations and details regarding the appropriate protocol language, informed consent and logistics of this process would need to be carefully developed together with the regulatory authority," Pfizer stated in its comments.

But Johnson & Johnson's Janssen Pharmaceutical unit argued in separate comments that if participants withdraw from phase 3 trials so they can get a vaccine granted an EUA, the integrity of the studies could be jeopardized and there could be "serious ramifications." Janssen called on the FDA to discuss potential options at the advisory committee meeting.

Potential interference

Patti Zettler and other law professors from The Ohio State University in their comments urged the FDA to be "proactively transparent about any decisions on COVID-19 vaccine candidates as the law permits," in light of existing vaccine hesitancy and serious concerns about inappropriate political interference with the agency's scientific decision-making during the pandemic.

President Donald Trump has openly pressured the FDA to grant an EUA for a COVID-19 vaccine before the Nov. 3 U.S. election and had criticized the agency for issuing stricter EUA guidelines for the shots versus other products in which the mechanism has been used. But in a surprise move, the FDA on Oct. 6 tucked details of the EUA guidelines inside a briefing document for the upcoming advisory committee hearing. Hours later, the agency posted the full guidelines on its website.

A majority of the U.S. public, or 55%, think Trump has intervened in the FDA's work, an Oct. 16 poll from the nonpartisan, nonprofit Kaiser Family Foundation showed.

About 71% of American adults said they had a great deal or a fair amount of trust the FDA will make sure any COVID-19 vaccine is safe and effective, but 62% said they were very or somewhat worried the agency would rush a product to the U.S. market under political pressure.

The U.S. Government Accountability Office, the investigative arm of Congress, has agreed to look into whether Trump and his political appointees have interfered with the work of FDA and CDC, Democratic Sens. Patty Murray of Washington, Elizabeth Warren of Massachusetts and Gary Peters of Michigan said in an Oct. 19 statement.