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FDA’s Marks: Stricter Standards for COVID-19 Vax Were by Design

The FDA’s stricter standards for a COVID-19 vaccine are meant to reassure the public about the safety and efficacy of a vaccine, and end the politicization of vaccine standards, the FDA’s top official for vaccines said Wednesday.

Data from phase III studies with a median follow-up duration of at least 2 months, and at least five severe COVID-19 cases in the placebo group, were standards proposed by the FDA for weeks. These standards were released in briefing documents the FDA made available to the public Tuesday.

Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research, emphasized the importance of tracking safety of the vaccine during an American Medical Association webinar on Wednesday.

“We asked for a median of 2 months of safety follow-up after the final vaccination of the population enrolled in the trial,” he said, explaining that when looking at adverse events, such as Guillain-Barre syndrome and transverse myelitis, they tend to occur within a median of 2 months or before.

“Some people would like longer than that, some people would like shorter than that [but] … that seems like a reasonable compromise,” he added.

Notably, President Trump lodged his objection on Tuesday night, calling the standards a “political hit job,” and saying they “make it difficult for them to speed up vaccine approvals before Election Day,” though the White House did approve the new standards.

In the webinar, Marks discussed the importance of clinical outcomes for COVID-19 vaccines. With other diseases, “we understand the correlates of protection,” and how that correlates with clinical outcome. These are not yet known for SARS-CoV-2.

“We expect these vaccines to reach clinical endpoints versus immunologic endpoints,” he said, noting that hopefully once the first couple vaccines are approved, the correlates of protection will become clearer.

Commenting on the new guidelines, Matthew Spinelli, MD, of University of California San Francisco, noted the line in the document where the FDA said it advised sponsors the agency “would not consider availability of a COVID-19 vaccine under emergency use authorization (EUA), in and of itself, as grounds for stopping blinded follow-up in an ongoing clinical trial.”

“It is very important that we continue follow-up to understand duration of protection, safety, long-term efficacy even if EUA issued,” Spinelli told MedPage Today via email. “My hope is that clinical trials that are sufficiently large are performed with adequate sample size and follow-up to ensure there are no safety signals.”

Marks said one of the “core pieces” of the FDA guidance was that the vaccine must be 50% more effective in preventing SARS-CoV-2 infection, though he stated a vaccine with 70%-80% efficacy, and 70-80% of people taking it, could bring about herd immunity.

Spinelli also noted the efficacy point estimate the FDA is targeting is similar to the seasonal flu vaccine.

Marks would not completely rule out an EUA, saying, it was at the “outer realm of possibility” that a vaccine could reach the number of clinical events needed by the end of

The F.D.A. releases stricter guidelines for vaccine developers after a holdup at the White House.

The Food and Drug Administration released updated, stricter guidelines on Tuesday for coronavirus vaccine developers — a step that was blocked for two weeks by top White House officials. The guidelines make it highly unlikely that a vaccine could be authorized by Election Day.

The move, which was cleared by the Office of Management and Budget, appeared to be an abrupt reversal a day after The New York Times reported that White House officials, including Mark Meadows, the chief of staff, were blocking the guidelines.

The new recommendations, which do not carry the force of law, call for gathering comprehensive safety data in the final stage of clinical trials before an emergency authorization can be granted.

On Tuesday evening, President Trump showed his displeasure at the action of his own White House, and charged that the new guidelines were a conspiracy against his reelection prospects.

“New F.D.A. Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” he tweeted, tagging Dr. Stephen M. Hahn, the F.D.A. commissioner.

Since the start of the coronavirus pandemic, the F.D.A. has said that it has been seeking ways to accelerate the development of vaccines without sacrificing safety. In June, the agency released an initial set of guidelines to give vaccine developers a better idea of how the F.D.A. would decide if a vaccine were acceptable, either for an emergency use authorization or for a full license.

Four vaccines have reached the final stage of testing, known as a Phase 3 trial, in the United States. A fifth is expected to start this month. President Trump has repeatedly suggested that a vaccine would be ready by Election Day, if not before.

But with public confidence declining in opinion polls about what could be a rushed coronavirus vaccine, the F.D.A. submitted a new set of guidelines to the White House for approval on Sept. 21.

Among the recommendations, the agency advised vaccine makers to follow volunteers for a median of two months after the final dose. The F.D.A. also expected vaccine makers to document five cases of severe infection in people who received the placebo instead of the vaccine.

The F.D.A. submitted the guidelines to the Office of Management and Budget for approval more than two weeks ago, but they stalled in part because of Mr. Meadows’s involvement, according to a senior administration official and others familiar with the situation.

The White House objected that the guidelines would add more time before a vaccine could be authorized. In a conversation with Dr. Hahn days after the guidelines were submitted, Mr. Meadows said the recommendations amounted to changing the rules on drugmakers in the throes of clinical trials, according to one senior administration official. He also suggested that Dr. Hahn was overly influenced by career scientists, who had drafted the document, the official said.

Trump administration officials have the authority to intervene with such nonbinding documents, partly because of a 2019 executive order that tightened