Donald Trump is urging Americans who have recovered from coronavirus to donate their blood plasma as he announced Sunday that the FDA has ...
Donald Trump is urging Americans who have recovered from coronavirus to donate their blood plasma as he announced Sunday that the FDA has given an emergency use authorization for convalescent plasma to be used as a treatment for coronavirus.
'This is a very big day,' the president touted.
These new authorization means those who had coronavirus and recovered can now donate their blood to be used as a treatment for those currently suffering from the disease.
'Today I'm pleased to make a truly historic announcement in our battle against the China virus that will save countless lives,' Trump said as he was flanked by Secretary of Health and Human Services Alex Azar and FDA Commissioner Stephen Hahn.
The president also revealed that the treatment has proven to reduce the chance of death from coronavirus by more than one third.
'I just want to empathize this point because I don't want you to gloss over this number. We dream in drug development of something like a 35 per cent mortality reduction,' Azar said of the convalescent plasma treatment, thanking the president.
'This is a major advance in the treatment of patients. This is a major advance,' he reiterated.
President Donald Trump announced Sunday that the FDA has now given emergency use authorization for convalescent plasma to be used as a treatment for coronavirus
'This is a very big day,' the president touted as he revealed this could lower the death rate from coronavirus by one-third as he was flanked by Health and Human Services Secretary Alex Azar (left) and FDA Commissioner Stephen Hahn (right)
'We dream in drug development of something like a 35 per cent mortality reduction,' Azar said of the convalescent plasma treatment. 'This is a major advance in the treatment of patients'
By approving the use of convalescent plasma now those who have antibodies for coronavirus after already having the disease can donate their blood to be used to treat those who currently have it
Trump claimed that over 100,000 Americans have already enrolled to receive this treatment.
'Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective,' Trump assured, highlighting that he was not the one pushing for the approval.
White House Press Secretary Kayleigh McEnany previewed Saturday that President Trump would announce a 'major therapeutic breakthrough' for coronavirus.
She tweeted that U.S. Health and Human Services Secretary Alex Azar and Food and Drug Administration head Stephen Hahn would be attending the 6pm Sunday press conference about the ' China Virus' breakthrough.
Trump has spent the past few months pushing the use of anti-malarial drugs hydroxychloroquine and chloroquine for the treatment of coronavirus.
The FDA revoked its authorization of the emergency use of the two drugs to treat coronavirus patients on June 15, citing the fact that clinical trials showed the drugs had 'no benefit for decreasing the likelihood of death or speeding recovery.'
On Saturday, Trump dredged up a tweet about the FDA revoking the authorization from two and a half weeks ago and wrote: 'Many doctors and studies disagree with this!'
He did not provide any examples of doctors or studies to back up his statement.
Earlier on Saturday, Trump also accused 'The deep state, or whoever' at the FDA of holding up testing for coronavirus vaccines and therapeutics.
White House Press Secretary Kayleigh McEnanay made the press conference announcement late Saturday night where she said President Trump would reveal a 'major therapeutic breakthrough' on coronavirus
Earlier on Saturday, Trump tweeted the 'deep state' in the FDA was holding up coronavirus vaccine and treatment testing and supported the use of anti-malarial drugs as treatment
'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,' Trump tweeted.
'Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!'
Trump tagged Hahn in the tweet.
On Thursday, Hahn had said that he could not speculate on when the FDA might approve a coronavirus vaccine, but said that the process was moving quickly.
'That's not because anyone has been cutting corners. It's because it's taken a concerted effort and we haven't done things in sequence, we've done things in parallel,' Hahn told Gray DC.
Despite Trump saying that he wanted the vaccine to be ready by early November, Hahn said that: 'The only facts FDA will look at with respect to a vaccine when the data come to us is those data and science and the medicine.'
He added that 'I've had absolutely no pressure from anyone.'
Earlier this week, a top FDA official who will help decide the fate of a coronavirus vaccine has vowed to resign if the Trump administration approves a vaccine before it is shown to be safe and effective.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said that he would resign if the Trump administration approved a vaccine before it was shown to be safe and effective.
Like Hahn, Marks said he has not faced any political pressure and that the FDA would be guided by science alone.
'I could not stand by and see something that was unsafe or ineffective that was being put through,' he told Reuters.
'You have to decide where your red line is, and that's my red line. I would feel obligated [to resign] because in doing so, I would indicate to the American public that there's something wrong.'
He added that he would equally object if someone sought political gain by holding up approval of a vaccine that was shown to work, and that was safe.
Michael Caputo, assistant secretary for public affairs at the Department of Health and Human Services, which oversees FDA and NIH, said the government aims to identify a safe and effective vaccine by January 2021.
Speculation about the FDA approving a vaccine under political pressure 'only undermines confidence in the public health system,' Caputo said in a statement.
'I've never met one FDA regulator who wouldn't resign over improper pressure, and that's how America knows their seal of approval is the gold standard.'
Trump's approval ratings have fallen sharply in the wake of a pandemic that has killed more than 173,000 Americans and infected over 5.5 million. The race to produce a vaccine has become the centerpiece of his administration's response.
Earlier this month, Trump said a vaccine was possible before the November 3 vote.
In a statement on Thursday, FDA Commissioner Hahn said that under Marks' leadership, the agency's scientists are monitoring the COVID-19 vaccine trials, 'the data from which will be the deciding factor for any FDA approval.'
Anthony Fauci, the nation's leading infectious disease expert, has also said publicly that political considerations will not influence any decision on a coronavirus vaccine.
Large-scale clinical trials of the leading vaccine candidates from Moderna, Pfizer and AstraZeneca were launched in recent weeks.
The FDA has scheduled a meeting of its advisory committee of outside experts on coronavirus vaccines on October 22.
Marks said the trials were enrolling volunteers 'reasonably well' and that it was 'possible' data could be available to interpret as early as October.
If not, the committee could still discuss broader regulatory issues regarding a vaccine, he said.
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