US FDA’s New Stricter Guidelines for Emergency Approval of COVID-19 Vaccine Blocked by White House

A recent report by The Washington Post had stated that the FDA’s guidance for emergency authorization of a COVID-19 vaccine would be much stricter as compared to the one issued earlier for hydroxychloroquine or convalescent plasma. As per the guidance, the FDA could ask vaccine manufacturers seeking an emergency authorization to follow participants in late-stage clinical trials for a median of at least two months, beginning after they have been administered a second vaccine shot.

In order to ensure that the COVID-19 vaccine works, the FDA may look for a minimum of five severe cases of COVID-19 in the placebo groups of all the trials, as well as some cases in older people. These tougher standards, coupled with the time required for the vaccine makers to prepare their applications as well as for the FDA to review the data, would make it highly unlikely for any COVID-19 vaccine to be authorized before the US presidential election. The new guidance was being reviewed by the White House Office of Management and Budget, and elements of it have already been shared with the vaccine makers.

However, according to a report by the New York Times, top White House officials are blocking the new stricter FDA guidelines for the emergency release of a COVID-19 vaccine, objecting to a provision that would ensure no vaccine can be authorized before the US election on November 3. The FDA is responding to this by finding other means to ensure that the COVID-19 vaccines meet the guidelines such as sharing the standards with an outside advisory committee of experts that would meet publicly before any COVID-19 vaccine is authorized for emergency use. The FDA hopes that the committee will enforce the guidelines, irrespective of the White House’s reaction, people familiar with the approval process told the New York Times.

Meanwhile, President Trump’s health secretary, Alex M. Azar II, told a House panel that those concerned about the White House’s involvement in the stricter FDA guidelines were making “a mountain out of a molehill.”

“What the commissioner is proposing to put out is public emergency use authorization guidance on a vaccine that would be consistent with letters already sent to the manufacturers,” said Mr. Azar. “The FDA has already told the manufacturers what they’re going to look for.”

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US Food and Drug Administration (FDA)