White House OKS FDA vaccine rules

Approval comes after standards were posted online

The White House on Tuesday, after weeks of delay, approved tough new standards for coronavirus vaccines — but only after the Food and Drug Administration unilaterally published the guidelines on its website as part of briefing materials for outside vaccine advisers.

The standards, which would be applied to an emergency use authorization for a vaccine, are the ones the agency proposed weeks ago. In many ways, they are similar to the standards for a traditional approval. But the White House, worried that the criteria would delay authorization of a vaccine, presumably beyond the Nov. 3 election, decided to sit on the guidance.

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 [COVID -19] vaccine development has been eroded by the politicization of the process.”

The delayed clearance occurred days after President Donald 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 justification from the agency about the criteria. Meadows’ action raised fears the White House would thwart or block standards designed to boost public trust in a vaccine, according to individuals familiar with the situation.

The FDA provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity. On Tuesday, tired of the delay, the FDA circumvented the White House by publishing the criteria online as part of a briefing package for an Oct. 22 meeting with its vaccine advisory committee.

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

The guidance is more rigorous than what was used for emergency clearance of hydroxychloroquin or convalescent plasma.

Pablo Martinez Monsivais / Associated Press Albert Bourla, Pfizer CEO, says his company won’t succumb to political pressure over a coronavirus vaccine.