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October 7, 2020
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FDA publishes vaccine guidelines opposed by White House
Associated Press
WASHINGTON (AP) — The
Food and Drug Adminis-
tration released updated
safety standards Tuesday
for makers of COVID-19
vaccines after the White
House blocked their formal
release, the latest political
tug-of-war between the
Trump administration and
the government's public
health scientists.
In the new guidelines post-
ed on its website, the FDA
said vaccine makers should
follow trial participants for
at least two months to rule
out safety issues before
seeking emergency ap-
proval. That requirement
would almost certainly pre-
clude the introduction of a
vaccine before Nov. 3.
President Donald Trump has
repeatedly insisted a vac-
cine could be authorized
before Election Day, even
though top government
scientists working on the ef-
fort have said that timeline In this July 27, 2020, file photo, Nurse Kathe Olmstead prepares a shot that is part of a possible COVID-19 vaccine, developed by
is very unlikely. On Monday the National Institutes of Health and Moderna Inc., in Binghamton, N.Y.
Trump said vaccines are Associated Press
coming "momentarily," in a
video recorded after he re- ception that a vaccine lions of Americans. blocked FDA’s plans to ment, arguing there was
turned to the White House. was being rushed out for A senior administration of- formally publish the safety “no clinical or medical rea-
Former FDA officials have political reasons could de- ficial confirmed Monday guidelines based on the son” for it.
warned that public per- rail efforts to vaccinate mil- that the White House had two-month data require- Continued on next page