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FDA authorizes Pfizer, First COVID-19 Vaccine in the United States




On December 11, 2020, FDA authorized the first EUA (Emergency Use of Authorization) for a vaccine for COVID-19) for individuals 16 years of age and older. FDA issued EUA that allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S and this is quite a historic moment in a pandemic that has killed over 290,000 in this nation and nearly 1.6 million people worldwide.


Pfizer, which produced the vaccine alongside German company BioNTech, has said it will ship the doses from its Michigan warehouse directly to those sites, pre-selected by governors and local health officials.


"Today, we can begin to turn millions of Americans' hopes into reality," Pfizer CEO Albert Bourla said. "That's because we have received the great news that the FDA has authorized the emergency use of our COVID-19 vaccine for people 16 or older."

The second batch of 2.9 million doses was expected to follow close behind, with the U.S. government opting to keep 500,000 doses in reserve to address any shipping or distribution mishaps.


After the approval of the vaccine, President Donald Trump immediately posted a video statement to Twitter.

"Today our nation has achieved a medical miracle. We have delivered a safe and effective vaccine in just nine months," he said in a message taped in the Oval Office. "This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all. I am thrilled to report that the FDA has authorized the Pfizer vaccine. We have given Pfizer and other companies a great deal of money, hoping this will be the outcome, and it was."


It is the first vaccine that uses genetic technology mRNA to be authorized in the United States. Data from clinical trials involving 44,000 volunteers this year estimated the vaccine to be 95% effective against COVID-19 without any serious side effects. Fatigue, headaches, and swelling at the injection site were noted.


The authorization comes after federal advisers -- an independent group of infectious disease experts, doctors, and scientists -- agreed the benefits of the Pfizer vaccine strongly outweighed any potential risks based on trial data.


"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization," Denise M. Hinton, chief scientist at the FDA, wrote in approving the EUA.


The U.K. has already begun distributing the vaccine. Regulators in Mexico and Canada also endorsed the vaccine. Following reports of two severe allergic reactions in the U.K., the FDA warned the vaccine should not be given to individuals known to be severely allergic to any component of the vaccine.


Dr. Anthony Fauci, the nation's top infectious disease doctor, said he was expecting such a warning and that it wouldn't necessarily mean that people with unrelated allergies can't get the vaccine.


"Now that we've got this heads up, what you do is what you do with everything in clinical medicine: You stay alert for it, and you keep a situation so that if it happens again, that people are in a facility that can take care of it," he said in an online interview with the Journal of the American Medical Association on Friday. "I don't think it should mitigate against people getting vaccinated because we don't know the extent."


Along with Pfizer, another vaccine candidate for COVID-19, Moderna is also awaiting EUA authorization. According to the recent update of the FDA, they are setting another stage for an emergency authorization in near that would add a second vaccine against the pandemic.






SOURCE: https://www.fda.gov/news-events/press-announcements/fda-takes-key-action-fight-against-covid-19-issuing-emergency-use-authorization-first-covid-19


 

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