FDA Sets Stringent Vaccine Approval Standards After White House Reverses Its Block
The FDA published guidelines requiring two months of safety information be included for any COVID-19 vaccine applying for emergency use authorization. Before giving surprise clearance, the White House previously blocked the strict standards, which make it unlikely any vaccine will be approved before Election Day.
The New York Times:
In Reversal, White House Approves Stricter Guidelines For Vaccine Makers
The move, which was cleared by the White House’s 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. Top F.D.A. officials were caught by surprise when they learned midafternoon that the new guidelines had been cleared. 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. (Zimmer and Weiland, 10/6)
The Washington Post:
White House Clears Food And Drug Administration Coronavirus Vaccine Standards It Tried To Derail
The standards, which would be applied to an emergency use authorization for a vaccine, are the same as 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 [coronavirus] vaccine development has been eroded by the politicization of the process.” (McGinley, Abutaleb and Johnson, 10/7)
Stat:
Race For Covid-19 Vaccine Slows As U.S. Officials Tap The Brakes
The race for a Covid-19 vaccine slowed on Tuesday, as both U.S. regulators and the head of the Trump administration’s Operation Warp Speed initiative tapped ever so softly on the brakes. The Food and Drug Administration released strengthened rules for authorizing any Covid-19 vaccine on an emergency basis. And Moncef Slaoui, co-chair of Operation Warp Speed, revealed that the government’s vaccine fast-tracking effort has urged manufacturers not to apply for emergency use authorization until they have significant amounts of vaccines to deploy. (Branswell and Herper, 10/6)
The Hill:
FDA Asking COVID-19 Vaccine Developers For Two Months Of Safety Data, Raising Doubts About Approval By Election Day
The Food and Drug Administration (FDA) wants coronavirus vaccine developers to submit two months of safety data before applying for emergency approval, circumventing the White House, which has expressed concerns about the stringent requirements. The FDA, in documents posted online Tuesday, advised drugmakers conducting COVID-19 vaccine clinical trials to monitor patients for at least two months to assess potential negative effects from their candidates. (Hellmann, 10/6)
In related news —
The Hill:
Trump Lashes Out At FDA Over Vaccine Guidelines
President Trump tore into the Food and Drug Administration (FDA) on Tuesday night after it unveiled new coronavirus vaccine guidelines. “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!” Trump tweeted. (Axelrod, 10/6)
