FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization

LukSkyFokker

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FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “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. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”​

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. 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 potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.
 
I like the way you copy and paste news items for people on the internet who can’t find the News on their own.
 
Actually I was talking to roryvonbismarklukedownsouth but thanks for the status report. :)
 
I begin daily testing on Tuesday. Thankfully it's a saliva-based collection system and not a daily NP.

By the time I'm due for the jab the vaccinated population will be large enough to detect issues.
 
Glad the healthcare workers will get it (vaccine) first!
 
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Well I come here to this pornography forum for ALL my covid updates. :)

Dr Luk

Dr-Luke-300x200.jpg
 
Perhaps ... coerced?

White House threatens FDA chief’s job over vaccine approval
By JONATHAN LEMIRE, DARLENE SUPERVILLE and MATTHEW PERRONE
today

WASHINGTON (AP) — Hours before the Food and Drug Administration authorized the first COVD-19 vaccine late Friday, a high-ranking White House official told the agency’s chief he could face firing...

https://apnews.com/article/donald-t...rus-pandemic-0902fbb041b0459e55da86be75b1457a
 
Perhaps ... coerced?

White House threatens FDA chief’s job over vaccine approval
By JONATHAN LEMIRE, DARLENE SUPERVILLE and MATTHEW PERRONE
today

WASHINGTON (AP) — Hours before the Food and Drug Administration authorized the first COVD-19 vaccine late Friday, a high-ranking White House official told the agency’s chief he could face firing...

https://apnews.com/article/donald-t...rus-pandemic-0902fbb041b0459e55da86be75b1457a


They are still under the delusion they can steal the presidency even after all those judicial smackdowns, trying to take credit under his name.

The irony, the UK is already administering the vaccine, so the immature mango face can't yell, "FIRST"! (Apologies to mangoes, mangoes are sweet and juicy, he's a bitter, old, dried up prune)
 
The Trump Administration's FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Today, Trump's Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.



The FDA has determined that Pfizer-BioNTech Trump Vaccine has met the statutory criteria for issuance of an EUA. 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 potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine supported by Trump's Warp Speed Program contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Thanks, Trump!
 
I said something like this earlier, but getting a safe vaccine less than a year after the virus was identified is probably the greatest scientific accomplishment since the Apollo program.

There's still the matter of getting it distributed though, and given the dysfunction in multiple levels of American society, that's not a sure bet. But I'll be on the alert for my turn.
 
I said something like this earlier, but getting a safe vaccine less than a year after the virus was identified is probably the greatest scientific accomplishment since the Apollo program.

There's still the matter of getting it distributed though, and given the dysfunction in multiple levels of American society, that's not a sure bet. But I'll be on the alert for my turn.

Minus the if it works caveat. :)
 
I said something like this earlier, but getting a safe vaccine less than a year after the virus was identified is probably the greatest scientific accomplishment since the Apollo program.

There's still the matter of getting it distributed though, and given the dysfunction in multiple levels of American society, that's not a sure bet. But I'll be on the alert for my turn.


Moreso considering they had to fend off Operation Warp (Ow!) at the same time.
 
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