White House nixes tougher FDA guidelines on vaccine approval

White House has blocked new Food and Drug ministration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented ir approval before v. 3 election. At issue was FDA's planned requirement that participants in ongoing mass clinical trials for nearly a half-dozen vaccine candidates be followed for two months to ensure re are side effects and that vaccines provide lasting protection from virus in order to receive emergency approval.

A senior ministration confirmed move Monday evening, saying White House believed re was “ clinical or medical reason” to d ditional screening protocols. White House action was first reported by New York Times. FDA Commissioner Stephen Hahn has pledged that career scientists, t politicians, will decide wher any coronavirus vaccine meets clearly stated standards that it works and is safe. Vaccine development usually takes years, but scientists have been racing to shorten that time.

“Science will guide our decisions. FDA will t permit any pressure from anyone to change that,” Hahn said recently. “I will put interest of American people above anything else.”

FDA has faced criticism for allowing emergency use of some COVID-19 treatments backed by little evidence, but Hahn has said if vaccine makers want that faster path to market, y would face ditional standards. Vaccines, unlike rapies, are given to healthy people and thus usually require more proof.

But President Donald Trump me clear last month that he was skeptical of any regulatory changes that might delay a vaccine’s authorization, even if those changes are aimed at increasing public trust. Asked about FDA considering stricter guidelines for emergency approval, Trump suggested effort was politically motivated.

“I think that was a political move more than anything else,” he said n, arguing that that companies testing vaccines, such as Pfizer, Johnson & Johnson and Moderna, are capable of determining wher y work. “I have tremendous trust in se massive companies,” he said.

senior ministration official, who spoke on condition of anymity to discuss action, said White House was intent on getting a safe vaccine to market and wanted to make sure “ditional loopholes” weren't ded that would slow down process.

(Im Credits: AP)

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