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WASHINGTON: The White House has blocked new Food and Drug Administration (FDA) guidelines on the marketing of potential vaccines for COVID-19 that would almost certainly have prevented their approval before the November 3 election.
What was at stake was the FDA’s planned requirement that participants in ongoing massive clinical trials for nearly half a dozen candidate vaccines be followed for two months to ensure there are no side effects and that the vaccines provide long-lasting protection. against the virus to receive emergencies. approval.
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A senior administration confirmed the move late Monday (October 5), saying the White House believed there was “no clinical or medical reason” to add additional screening protocols.
The White House action was first reported by The New York Times.
FDA Commissioner Stephen Hahn has promised that career scientists, not politicians, will decide whether any coronavirus vaccine meets clearly established standards that it works and is safe. Vaccine development generally takes years, but scientists have been racing to shorten that time.
“Science will guide our decisions. The FDA will not allow any pressure from anyone to change that, ”Hahn said recently.
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“I will put the interest of the American people above anything else.”
The FDA has faced criticism for allowing the emergency use of some COVID-19 treatments backed by little evidence, but Hahn has said that if vaccine makers want that faster path to market, they would face additional standards. Vaccines, unlike therapies, are given to healthy people and therefore generally require more testing.
But President Donald Trump made clear last month that he was skeptical of any regulatory changes that could delay the authorization of a vaccine, even if those changes are aimed at increasing public confidence. When asked if the FDA was considering stricter guidelines for emergency approval, Trump suggested that the effort was politically motivated.
“I think it was a political move more than anything else,” he said at the time, arguing that companies that test vaccines, such as Pfizer, Johnson & Johnson and Moderna, are able to determine if they work.
“I have enormous confidence in these massive companies,” he said.
The senior administration official, who spoke on condition of anonymity to discuss the action, said the White House intended to bring a safe vaccine to market and wanted to make sure no “additional loopholes” were added that would slow down the process.
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