Updated: March 6, 2021
The Food and Drug Administration (FDA) vaccine panel on Thursday voted to approve an emergency use authorization of the Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) coronavirus vaccine in the United States.
Federal officials, who met at an FDA vaccine panel on Thursday to review clinical trial data, said overwhelmingly that the coronavirus vaccine is safe and can be used on Americans.
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Members of the panel voted 17 in favor, 4 against and there was one abstention. Now the FDA is set to make a final approval in the coming days and the CDC advisory will make a decision on Sunday on when to distribute it.
The panel recommended that more studies will need to be conducted on some groups of people.
There has not been enough studies on how the Pfizer/BioNtech vaccine will behave on people who have had severe reactions to vaccines in the past and on pregnant women.
The clinical trials focused on healthy people with no other conditions and some health workers who received the first doses of the vaccine in the United Kingdom early this week had some adverse reactions.
The approval of the vaccine comes only a day after the United States recorded its highest daily death toll from coronavirus. More than 3100 Americans died of the virus on Wednesday and over 200,000 others contracted the respiratory disease.
So far, more than 291,000 Americans have died of the virus, and over 2000 others have already died today.
The vaccine could not have come at a better time, but it will take months before the general public can be vaccinated.
The next step will be for the distribution of the vaccine that has be kept at below 70 degree celsius temperature.
Apart from distributing the vaccine, and transporting it and keeping it at the right temperature, many Americans do not seem ready to take the vaccine, and a lot of trusted voices and public relations mechanisms would be used to convinced the general public it is safe to take it.
Earlier on Thursday, the New England Journal of Medicine published safety and final efficacy results from the pivotal Phase 3 trial of BNT162b2, Pfizer Inc. and BioNTech SE mRNA-based COVID-19 vaccine candidate.
In the trial of 43,448 participants, who were 16 years and older, 21,720 of whom received BNT162b2 and 21,728 placebo, the two-dose regimen of 30 μg BNT162b2, which was given 21 days apart, was well-tolerated and demonstrated vaccine efficacy of 95% against COVID-19.
“These pivotal data demonstrate that our COVID-19 vaccine candidate is highly effective in preventing COVID-19 disease and is generally well-tolerated. They are a testament to the extraordinary efforts to deliver an effective vaccine with a favorable safety profile rapidly and serve as the basis for our regulatory submissions around the world,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. “As COVID-19 cases continue to rise and ravage the lives of so many people, we hope that these data will build confidence in the global health opportunity for vaccines to help us combat this devastating pandemic.”
According to Özlem Türeci, M.D., Chief Medical Officer and Co-founder of BioNTech, “We are very encouraged by the data, which indicate that our vaccine candidate is well-tolerated and highly potent irrespective of age, gender, ethnicity, and pre-existing comorbidities. These are all critical factors for a vaccine to be effective in helping to address the pandemic.”
“Sharing further data from the Phase 3 trial in a renowned peer-reviewed journal underlines our commitment to transparency and scientific rigor. We consider both important at this important junction with additional potential authorizations of our vaccine in sight.”