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By Nandita Bose and Aram Roston
Aug 23 (Reuters) - President Donald Trump on Sunday hailed
FDA authorization of a coronavirus treatment that uses blood
plasma from recovered patients, a day after accusing the agency
of impeding the rollout of vaccines and therapeutics for
political reasons.
The U.S. Food & Drug Administration (FDA) announcement of
its "emergency use authorization" of the treatment came on the
eve of the Republican National Convention, where Trump will be
nominated to lead his party for four more years.
"This is what I've been looking to do for a long time,"
Trump told an unusually brief White House news conference.
"Today I'm pleased to make a truly historic announcement in our
battle against the China virus that will save countless lives."
The FDA, explaining its decision, cited early evidence
suggesting blood plasma can decrease mortality and improve the
health of patients when administered in the first three days of
their hospitalization.
The agency also said it determined this was a safe approach
in an analysis of 20,000 patients who received the treatment. So
far, 70,000 patients have been treated using blood plasma, the
FDA said.
"It appeared that the product is safe and we're comfortable
with that and we continue to see no concerning safety signals,"
Peter Marks, director of the FDA's Center for Biologics
Evaluation and Research, told reporters in a conference call.
A day before the FDA's announcement, Trump tagged the
agency's Commissioner Stephen Hahn in a Twitter post in which he
said, "The deep state, or whoever, over at the FDA is making it
very difficult for drug companies to get people in order to test
the vaccines and therapeutics." "Obviously, they are hoping to
delay the answer until after November 3rd. Must focus on speed,
and saving lives!"
Trump is looking to boost his lagging poll numbers during
the Republican convention this week, and progress in treatments
or an effective vaccine to gain control of the virus would aid
his re-election chances.
At least 5,686,377 cases of COVID-19 have been reported in
the United States, according to a Reuters tally, and more than
176,000 Americans have died.
U.S. regulators provided emergency authorization for Gilead
Science Inc's remdesivir as a therapeutic treatment for COVID-19
earlier this year. Reuters reported that a senior administration
official said therapeutic drugs that are being studied
specifically for COVID-19 could be authorized for use and making
doses by fall.
The White House declined to comment on a separate report in
the Financial Times that the administration is considering
fast-tracking an experimental COVID-19 vaccine being developed
by AstraZeneca Plc and Oxford University for use in the
United States ahead of the Nov. 3 elections.
One option being explored would involve the FDA awarding
emergency use authorization in October to the potential vaccine,
which was developed by Oxford and licensed to AstraZeneca, the
FT reported https://www.ft.com/content/b053f55b-2a8b-436c-8154-0e93dcdb3c1a,
citing people briefed on the plan.
A spokeswoman for AstraZeneca denied the company had
discussed an emergency use authorization for its potential
vaccine with the U.S. government and said it would be premature
to speculate on that possibility.
The company said the late-stage Phase 2 and Phase 3 trials
for its vaccine candidate are still ongoing in Britain and other
markets globally and that it did not anticipate efficacy results
until later this year.
There are no approved vaccines for COVID-19, but
AstraZeneca's shot, called AZD1222, is widely seen as one of the
leading candidates.
(Reporting by Nandita Bose in Washington, Carl O'Donnell in New
York, and Shubham Kalia and Bhargav Acharya in Bengaluru;
Writing by Phil Stewart and David Lawder; Editing by Chizu
Nomiyama and Daniel Wallis)
