The Food and Drug Administration gave emergency use authorization for the first time to a coronavirus vaccine, a milestone in the fight against the pandemic that has resulted in the deaths of nearly 300,000 Americans.
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met Fda’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” said Fda administrator Stephen Hahn.
The vaccine comes from Pfizer-BioNTech. They have been among a number of biomedical firms that have been racing to develop a vaccine that is safe and effective.
The Fda said that “the totality of the available data provides clear evidence that Pfizer-BioNTech Covid-19 Vaccine may be effective in preventing Covid-19. The data also support that the known and...
“Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met Fda’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” said Fda administrator Stephen Hahn.
The vaccine comes from Pfizer-BioNTech. They have been among a number of biomedical firms that have been racing to develop a vaccine that is safe and effective.
The Fda said that “the totality of the available data provides clear evidence that Pfizer-BioNTech Covid-19 Vaccine may be effective in preventing Covid-19. The data also support that the known and...
- 12/12/2020
- by Ted Johnson
- Deadline Film + TV
Donald Trump said that the White House would have to approve an effort by the Food and Drug Administration to impose stricter standards for a coronavirus vaccine.
The Washington Post reported that the Fda is moving toward new guidance for emergency authorization of a vaccine, which would make it unlikely that it would get a green light before Election Day.
“That has to be approved by the White House,” Trump said. “We may or may not approve it. It sounds like a political move, because when you have Pfizer, Johnson & Johnson, Moderna. These great companies coming up with vaccines and they have done testing and everything, I am saying why would they be adding great length to the process. …I think that was a political move more than anything else.”
But polling suggests that there is sagging public trust in a vaccine. An Axios-Ipsos poll showed that just...
The Washington Post reported that the Fda is moving toward new guidance for emergency authorization of a vaccine, which would make it unlikely that it would get a green light before Election Day.
“That has to be approved by the White House,” Trump said. “We may or may not approve it. It sounds like a political move, because when you have Pfizer, Johnson & Johnson, Moderna. These great companies coming up with vaccines and they have done testing and everything, I am saying why would they be adding great length to the process. …I think that was a political move more than anything else.”
But polling suggests that there is sagging public trust in a vaccine. An Axios-Ipsos poll showed that just...
- 9/23/2020
- by Ted Johnson
- Deadline Film + TV
On Saturday, President Donald Trump fired off one of his most deranged, conspiratorial, and flat-out terrifying tweets since he took office — which at this point is really saying something.
“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,” he wrote. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
The deep state, or whoever, over at the Fda is making it...
“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,” he wrote. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”
The deep state, or whoever, over at the Fda is making it...
- 8/24/2020
- by Ryan Bort
- Rollingstone.com
Update: Anthony Fauci said that they “hope to know” in late fall or early winter whether the development of a coronavirus vaccine is successful.
He said that he was “cautiously optimistic” that there will be a vaccine with “some degree” of effectiveness. Eight vaccines are in development, he said.
“We have many candidates and hope to have multiple winners,” Fauci told a Senate committee on Tuesday, as he outlined the relatively rapid pace of development of a vaccine and treatment for the virus.
He also warned that there were potential downsides.
“I must warn that there is also the possibility of negative consequences, where certain vaccines may enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will there be presence or absence, and how durable will it be?”
He also said that it was “a bit of a bridge too far” to expect that a...
He said that he was “cautiously optimistic” that there will be a vaccine with “some degree” of effectiveness. Eight vaccines are in development, he said.
“We have many candidates and hope to have multiple winners,” Fauci told a Senate committee on Tuesday, as he outlined the relatively rapid pace of development of a vaccine and treatment for the virus.
He also warned that there were potential downsides.
“I must warn that there is also the possibility of negative consequences, where certain vaccines may enhance the negative effect of the infection,” he said. “The big unknown is efficacy. Will there be presence or absence, and how durable will it be?”
He also said that it was “a bit of a bridge too far” to expect that a...
- 5/12/2020
- by Ted Johnson
- Deadline Film + TV
Dr. Anthony Fauci, the nation’s top infectious-disease expert, who has stood beside President Trump throughout much of the administration’s response to the coronavirus, will tell the Senate Tuesday that Americans will experience “needless suffering and death” if the country reopens prematurely.
“If we skip over the checkpoints in the guidelines to ‘Open America Again,’ then we risk the danger of multiple outbreaks throughout the country,” Fauci wrote in an email to The New York Times , previewing the comments he will make before the Senate Health Committee. “This will...
“If we skip over the checkpoints in the guidelines to ‘Open America Again,’ then we risk the danger of multiple outbreaks throughout the country,” Fauci wrote in an email to The New York Times , previewing the comments he will make before the Senate Health Committee. “This will...
- 5/12/2020
- by Ryan Bort
- Rollingstone.com
Trevor Noah marveled at how President Donald Trump falsely claimed that there was a readily available coronavirus treatment on the latest installment of The Daily Social Distancing Show.
From the confines of his home, Noah spoke about Thursday’s press conference, where Trump boasted that a malaria drug called chloroquine would soon be available as a coronavirus treatment. Moments later, however, Fda Commissioner Dr. Stephen Hahn was forced to address reporters and promptly say they still had to do a large clinical trial to see if chloroquine would actually be...
From the confines of his home, Noah spoke about Thursday’s press conference, where Trump boasted that a malaria drug called chloroquine would soon be available as a coronavirus treatment. Moments later, however, Fda Commissioner Dr. Stephen Hahn was forced to address reporters and promptly say they still had to do a large clinical trial to see if chloroquine would actually be...
- 3/20/2020
- by Jon Blistein
- Rollingstone.com
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