Pfizer Vaccine Emergency Use Authorization Request: When Will It Be Available For Public?
First-round doses of a COVID-19 vaccine by Pfizer could soon start rolling out to the public as Pfizer, the company that developed it, started the process to apply for emergency use authorization with the Food and Drug Administration on Friday.
The company, which announced earlier this month that their vaccine, developed with BioNTech, had an initial 90% efficacy in clinical trials, is applying with the FDA for Emergency Use Authorization. If approved, doses could start to roll out in a first wave by mid-December, CNBC reports.
The announcement also comes after a final data analysis found the vaccine to be 95% effective at preventing a COVID-19 infection.
“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,” Pfizer CEO Dr. Albert Bourla said in a statement.
The process with the FDA is expected to take a few weeks, and an advisory committee meeting to review it is currently scheduled for early December.
If the application is approved, the vaccine is expected to roll out in small limited phases, with health-care workers, the elderly and those with underlying health conditions being among the first to receive doses. Essential workers, teachers and people in homeless shelters and prisons would likely receive a second round of doses, with children and young adults likely to receive the next dose.
While the first to apply for Emergency Use Authorization, the Pfizer vaccine isn’t the only one that has had promising news surrounding it in recent days. Moderna also announced a high efficacy rate for a vaccine it is also developing, with initial results at 94%. However, despite the positive news about the vaccines potentially being much more effective, the public has been warned that they still need to follow social distancing guidelines, including mask-wearing and frequent hand-washing.
“The cavalry is coming but don’t put your weapons down, you better keep fighting because they are not here yet,” Dr. Anthony Fauci, the nation’s leading infectious disease expert, said. “We are not good to go. We have got to continue to double down on public health measures.”
Among the side effects that could come from the vaccine, according to a volunteer who participated in the clinical trials, are headaches, injection site pain, fatigue, fever, and body aches.
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