As of today, Pfizer will be the first pharmaceutical company to ask the FDA for emergency use authorization for a vaccine
Let’s get one thing straight: The coronavirus pandemic is not over, and we’re likely still many months away from life returning to anything resembling pre-pandemic normalcy. However, there is some very good news on that front today. Pfizer, one of the first drug making companies to announce results from its clinical trials for a COVID vaccine, is submitting that vaccine to the FDA for emergency use authorization today.
— Pfizer Inc. (@pfizer) November 20, 2020
“Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally,” Pfizer Chairman and CEO Dr. Albert Bourla said in the release. “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.”
Bourla continued, “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.”
NEW: Pfizer and BioNTech are submitting their application to the EUA for their vaccine candidare today.
Review and approval would be in early December.
— Andy Slavitt @ (@ASlavitt) November 20, 2020
Submitting for an emergency use authorization means the Pfizer vaccine — and the results from its safety and efficacy trials — will now go before a series of regulatory boards at the FDA and CDC. Those boards include independent scientists and experts who are not employees of any government agency. That’s meant to give the boards complete independence and freedom from political pressure while the review the vaccine.
If approved by all necessary agencies, Pfizer has pre-manufactured 50 million doses of its vaccine that can then begin to be distributed. That means that people first in line for the vaccine — healthcare workers and those in particularly high-risk groups for coronavirus infection — could start receiving their shots by the end of the year.
248 long days and nights
150 active clinical trial sites
43,661 courageous volunteers
Thousands of dedicated @Pfizer and @BioNTech_Group colleagues
And the hopes of billions
All leading to 1 historic moment
#PfizerProud of our FDA Submission today: https://t.co/uyo6XfGSOO
— AlbertBourla (@AlbertBourla) November 20, 2020
Pfizer made a lot of headlines when it announced the preliminary results of its clinical trial, showing the vaccine was 90 percent effective — much more effective than scientists had hoped. However, even if the vaccine is approved for emergency use, there are still many hurdles to overcome to distribute it across the country (and the rest of the world) and vaccinate enough people to begin to beat back raging surges of coronavirus cases. Pfizer’s vaccine requires two shots taken a few weeks apart, and it needs to be stored in a special deep freezer that many pharmacies don’t have.
Still, this is great news for a pandemic-stricken world, and represents a major scientific step forward.
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