FDA guidance – The Washington Post


One of the pharmaceutical companies at the forefront of efforts to develop a vaccine, Pfizer, on Tuesday declared its support for the agency in its struggle with the White House. Albert Bourla, the company’s chief executive, said on Twitter, “Pfizer has never discussed [FDA’s] vaccine guidelines with the White House and will never do so as it could undermine the agency’s independence.” He said the agency’s independence “is today more important than ever as public trust in [coronavirus] vaccine development has been eroded by the politicization of the process.”

The delayed clearance by the White House occurred days after President Trump accused the FDA of being “political” in fashioning the guidance and after The Washington Post reported that White House Chief of Staff Mark Meadows was demanding detailed justification from the agency about the criteria. Meadows’s action raised fears the White House would thwart or block standards designed to boost public trust in a vaccine, according to people familiar with the situation who spoke on the condition of anonymity to discuss internal deliberations.

The FDA, as requested, provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity because they did not have permission to talk publicly about the issue. On Tuesday, tired of the delay, the FDA circumvented the White House by publishing the criteria online as part of a briefing package for a meeting with its vaccine advisory committee that is scheduled for Oct. 22.

Shortly after the standards were published, the White House approved the vaccine guidance, according to the official.

The guidance is far more rigorous than what was used for emergency clearance of hydroxychloroquine, an anti-malaria drug used in the early days of the coronavirus pandemic, or convalescent plasma, which is taken from people who have recovered from covid-19 and whose antibodies might offer a measure of protection to other patients. It is an effort to shore up confidence in the vaccine development process and the FDA, which has made missteps during the pandemic.

The guidelines recommend that participants in late-stage vaccine clinical trials be followed for a median of at least two months, starting after they receive a second vaccine shot — which experts said could make it difficult, though not impossible, for a vaccine to be authorized before the election.

The Post reported Sept. 22 that the FDA was poised to issue a tough new standard for an emergency authorization of a coronavirus vaccine. As a sign the vaccine works, the agency said it would want to see at least five severe cases of covid-19, the disease caused by the novel coronavirus, in the placebo group for each trial, and some cases of the disease in older people. Assuming there weren’t cases — or not as many — in the group receiving the vaccine, that would be a signal that a shot is working.

At a news conference Sept. 23, Trump said the FDA plan sounded like “a political move” and warned the White House might reject it.

Even as the White House rattled sabers, the head of the FDA section that oversees vaccines repeatedly said in public he would stick to the criteria and that he had told vaccine companies weeks ago what he was looking for to grant an emergency-use authorization.

“The companies know what we’re expecting,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said last week at an event sponsored by the advocacy group Friends of Cancer Research. He said the publication of the guidance was in large part designed to reassure the public that the FDA would use stringent standards in authorizing a vaccine.

Scott Gottlieb, a former FDA commissioner, said at a symposium on scientific integrity and vaccines Tuesday, “There are few moments I can think of where so much political dust was created by political officials for so little actual practical effect — and perhaps negative effect.”

He added, “The bottom line is, FDA is going to stick to the objective criteria that they outlined in the guidance, the [advisory committee] is going to support those principles, and the sponsors are going to adhere to them.”

Marks said at the conference that the criteria spelled out in the guidance is an attempt to build trust and confidence in vaccines that receive regulatory approval.

“We’ll continue to be as transparent as we can about what we do because ultimately we do need to make sure that regardless of where someone comes on the spectrum of their beliefs that they can at least trust in this and feel confident that what comes through our process is something, because we at FDA are comfortable giving that to our families, they will feel comfortable giving it to their families,” Marks said.

He added that the two-month time frame was chosen because data shows that the majority of side effects occur within two to three months of vaccination. For example, he said that side effects such as Guillain-Barre syndrome, when the immune system attacks the nerves, could occur about six weeks after vaccination, but an inflammation of the spinal cord would typically happen within three months.

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