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WASHINGTON: The U.S. Food and Drug Administration (FDA) told developers of the COVID-19 vaccine on Tuesday (October 6) that it wants at least two months of safety data before authorizing the use of emergency, a requirement that would likely drive the availability of any US vaccine 3 presidential elections.
A senior administration official confirmed that the White House had approved the plan, which undermines President Donald Trump’s hopes of receiving a vaccine before voters go to the polls.
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Trump expressed his displeasure in a Twitter post late Tuesday: “The new FDA rules make it harder for them to rush vaccine approvals before Election Day. Just another political success!”
The FDA published guidance establishing more stringent recommendations for drug manufacturers waiting to apply for an emergency use authorization (EUA) for their experimental vaccines.
The New York Times reported Monday that the White House had blocked the guidelines. The senior administration official said there had been no delay to the guide, which underwent a normal regulatory review.
The move is the latest effort by US officials to downplay policy around the vaccine and ensure public safety.
“Being open and clear about the circumstances under which the issuance of an emergency use authorization for a COVID-19 vaccine would be appropriate and is critical to building public trust and ensuring the use of COVID-19 vaccines once they are available, “Dr. Peter Marks, director of the FDA’s division responsible for approving vaccines, said in a statement.
The White House could still force the authorization of a vaccine without that additional safety data. Doing so would put you in open disagreement with the FDA and its career scientists, and increase the perception that politics is playing a role in promoting a vaccine.
If the agency follows its own guidelines, it is unlikely that it will authorize a vaccine before the end of November. You want two months of data from half the volunteers in a trial.
Pfizer Inc and its partner BioNTech are expected to be the first to announce the results of a late-stage US clinical trial.
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About half of the volunteers in the phase III trial of 44,000 subjects had received the second dose of the two-shot vaccine by the end of September.
Pfizer had previously said that it hoped to publish efficacy data beginning this month and provide the FDA with safety data, including the median safety data from two months after the second dose, on a continuous basis.
The head of the US government’s Operation Warp Speed vaccine development program said Tuesday that efficacy data for one or two vaccines will be available within the next few months, and that there should be enough supply to immunize 30 million people during November and December.
Moderna Inc appears to be likely the second company after Pfizer to have US test data available for a US review.
Pfizer Chief Executive Albert Bourla tweeted Tuesday that the company had not discussed FDA standards with the White House, saying that could compromise the agency’s independence.
“FDA public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment,” Bourla said.
FDA expects to hold separate meetings of its vaccine advisory committee before issuing an emergency use authorization for any experimental injection.
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