FDA commissioner says he is willing to fast-track COVID-19 vaccine before clinical trials are complete after Trump accused agency of delaying results until after the election

The head of the Food and Drug Administration says he is willing to fast-track a COVID-19 vaccine as quickly as possible, 
Dr. Stephen Hahn, the FDA Commissioner, said his agency was prepared to authorize a vaccine before Phase Three clinical trials were complete, as long as officials are convinced that the benefits outweigh the risks, the Financial Times reports. 
Without providing evidence, President Donald Trump last Saturday accused members of a so-called 'deep state' working within the FDA of complicating efforts to test COVID-19 vaccines in order to delay results until after the November 3 presidential election.
A day later, the FDA gave 'emergency use authorization' of a coronavirus treatment that uses blood plasma from recovered patients.
'Our emergency use authorization is not the same as a full approval,' Hahn told the FT, adding that his decisions will not be made because of political pressure.
'This is going to be a science, medicine, data decision. This is not going to be a political decision,' Hahn said, according to the report.
Dr. Stephen Hahn said the FDA was prepared to authorize a vaccine, as long as officials are convinced that the benefits outweigh the risks
Dr. Stephen Hahn said the FDA was prepared to authorize a vaccine, as long as officials are convinced that the benefits outweigh the risks
Heather Lieberman, left, 28, receives a COVID-19 vaccination from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Florida, on August 13
Heather Lieberman, left, 28, receives a COVID-19 vaccination from Yaquelin De La Cruz at the Research Centers of America in Hollywood, Florida, on August 13
Hahn said the safest way for the vaccine to be available for use before the end of Phase Three trials, which involve thousands of patients and can take years, would be by issuing an emergency authorization for use by certain groups rather than a blanket approval, the FT reported. 
Hahn was forced to apologize last week for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma. 
 Scientists and medical experts had been pushing back against the claims about the treatment since President Trump's announcement that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment's value has not been established. The announcement on the eve of Trump's Republican National Convention raised suspicions that it was politically motivated to offset critics of the president's handling of the pandemic.  
Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.
The FDA commissioner then fired its spokesperson Emily Miller after 11 days on the job.    
'I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,' Hahn tweeted.   
Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention. 
Donald Trump listens as Dr. Stephen Hahn speaks during a media briefing. Trump last Saturday accused members of a so-called 'deep state' working within the FDA of complicating efforts to test COVID-19 vaccines
Donald Trump listens as Dr. Stephen Hahn speaks during a media briefing. Trump last Saturday accused members of a so-called 'deep state' working within the FDA of complicating efforts to test COVID-19 vaccines
A health worker test a man for Covid-19 at a pop up testing location on the boardwalk at Revere Beach in Revere, Massachusetts on August 11. Hahn says his decisions will not be made because of political pressure
A health worker test a man for Covid-19 at a pop up testing location on the boardwalk at Revere Beach in Revere, Massachusetts on August 11. Hahn says his decisions will not be made because of political pressure
The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November's election. 
Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it's needed most. A vaccine will only be effective against the virus if it is widely taken by the U.S. population. 
Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed. 
FDA commissioner says he is willing to fast-track COVID-19 vaccine before clinical trials are complete after Trump accused agency of delaying results until after the election FDA commissioner says he is willing to fast-track COVID-19 vaccine before clinical trials are complete after Trump accused agency of delaying results until after the election Reviewed by STATION GOSSIP on 02:45 Rating: 5

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