Pfizer and BioNTech have sought an emergency approval of their coronavirus vaccine from the Food and Drugs Administration (FDA) in the US.
The two companies made the application on Friday, November 20, 2020, days after they announced that their vaccine has been found to be 90 percent effective against coronavirus.
In the event that the request is granted, the vaccine is to be distributed on a limited basis as President Donald Trump announced in a televised address days ago.
It is to be distributed in phases with frontline workers, the elderly and high-risk expected to first receive doses as indicated by the President.
Accordingly, other essential workers such as teachers and people in homeless shelters and prisons would likely be next, followed by children and young adults.
The approval process by the FDA, is due to take some weeks.
The vaccine is expected to first be reviewed by FDA advisory committee before a decision could be made.
By December this year as the President announced, the vaccine is expected to be distributed on the phase level.
Pfizer CEO Dr. Albert Bourla, noted in a statement on Friday that
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential.”
The announcement came after Pfizer reported that its final data analysis found its vaccine to be 95% effective in preventing Covid.
Accordingly, the final analysis evaluated 170 confirmed Covid infections among the late-stage trial’s more than 43,000 participants.
Pfizer and BioNTech reported that 162 cases of Covid were observed in the placebo group versus eight cases observed in the group that received its two-dose vaccine.
That resulted in an estimated vaccine efficacy of 95%, according to them.
The application for approval makes the Pfizer and BioNTech the first companies to take steps to get their vaccine approved.
Moderna has also reported that it found its vaccine 95% effective against coronavirus.
Pfizer’s vaccine requires a storage temperature of minus 94 degrees Fahrenheit, potentially posing challenges for widespread distribution.
On the other hand, Moderna’s vaccine vaccine must be stored at minus 4 degrees Fahrenheit.
President Trump in his recent address confirmed that the US government was spending some $1.95 billion to get the vaccine to Americans free of charge.
About 100 million doses are expected to be bought by the US as Pfizer announced on July 22, 2020.
The purchase of the 100 million doses forms part of the Trump administration’s vaccine program dubbed Operation Warp Speed.
The agreement permits the U.S. to acquire an additional 500 million vaccine doses.
President Trump said in his last address delivered from the Rose Garden of the White House on the Pfizer’s vaccine, that “our investment will make it possible for the vaccine to be distributed by Pfizer free of charge,” announcing at the time that his government will work with Pfizer “to secure an emergency use authorization which will be coming down extremely soon.”
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