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U.S. FDA asks COVID-19 vaccine developers for two months follow-up data


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!”

Reuters India - October 6, 2020

View the full story here: https://uk.reuters.com/article/health-coronavirus-fda-vaccine/u-s-fda-asks-covid-19-vaccine-developers-for-two-months-follow-up-data-idINKBN26R2IB