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FDA releases guidelines for coronavirus vaccine

FDA releases guidelines for coronavirus vaccine Photo: MGN.

LAURAN NEERGAARD, AP
Created: June 30, 2020 09:10 PM

(AP) — The Food and Drug Administration released guidelines Tuesday saying any vaccine that wins approval will have to be at 50% more effective than a dummy shot in the final, required testing. That's less effective than many of today's vaccines but independent experts say that would be a good start against the virus.

FDA Commissioner Stephen Hahn said vaccine makers also must test their shots in diverse populations, including minorities, the elderly, pregnant women and those with chronic health problems.

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"We will not cut corners in our decision-making," Hahn told senators.

About 15 vaccine candidates are in various stages of human testing worldwide but the largest studies -- including 30,000 people each -- needed to prove if a shot really protects are set to begin in July. First up is expected to be a vaccine created by the NIH and Moderna Inc., followed closely by an Oxford University candidate.

At the same time, the Trump administration's "Operation Warp Speed" aims to stockpile hundreds of millions of doses by year's end, so they could rapidly start vaccinations if and when one is proven to work.

Redfield said the CDC already is planning how to prioritize who is first in line for the scarce first doses and how they'll be distributed.

But a vaccine is at the very least many months away. For now, the committee's leading Republican stressed wearing a mask -- and said Trump, who notoriously shuns them, needs to start because politics is getting in the way of protecting the American people.


(Copyright 2020 by The Associated Press. All Rights Reserved.)

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