By Michael Erman and Manas Mishra
(Reuters) – The U.S. Food and Drug Administration told coronavirus vaccine developers on Tuesday it wants at least two months of safety data before authorizing emergency use, a requirement that would likely push any U.S. vaccine availability past the Nov. 3 presidential election.
A senior administration official confirmed the White House had approved the plan, which undercuts President Donald Trump’s hopes of getting a vaccine before voters go to polls.
Trump voiced his displeasure in a Twitter post late on Tuesday: “New FDA Rules make it more difficult for them to speed up vaccines for approval before Election Day. Just another political hit job!”
The FDA released the guidance laying out more stringent recommendations for drugmakers hoping to apply for an emergency use authorization (EUA) for their experimental vaccines.
The New York Times reported on Monday that the guidelines had been blocked by the