An FDA official said the final decision on Pfizer and BioNTech’s Covid-19 vaccine will be made “soon” after the US Food and Drug Administration designated their application for priority review. According to CNN, an FDA official told CNN on Friday that a final approval decision would likely be made within two months. A staff member who requested anonymity because he was not authorized to speak publicly on the matter said that this issue is a priority for the agency.
The FDA Will Render A Decision With Respect To The Licensing Of The BioNTech/Pfizer Covid-19 Vaccine Within 2 Months Of Its Prior Consideration By The Agency
BioNTech as well as Pfizer launched Covid-19 shots appeal in the month of May named a Biologics License Application. The corporations are asking for endorsement for the two-dose set for somebody aged 16 and older. They expect to ask for endorsement for somebody aged between 12 and 15; as soon as the data are ready.
Despite the FDA’s deadline of January, she said she is optimistic it will happen much sooner. Acting FDA Commissioner Janet Woodcock tweeted that the FDA is reviewing the BLA, which is among the agency’s top priorities, and that it will be completed well before January’s deadline.
FDA emergency use authorization is currently in place for all three vaccines. As Dr. Peter Marks stated in an op-ed piece published in the New York Times earlier this month, full approval of the Covid-19 vaccines is one of the FDA’s top priorities, but it requires a thorough review of the manufacturing process and clinical trials.
Marks thinks that encouraging shots without the accurate estimation and assessment demanded by all the Americans would weaken the agency’s legal authority, threaten public support, and do little to alleviate vaccine skepticism.
He noted that all 3 Covid-19 shots authorized for distribution in the United States have been authorized for distribution in children as young as 12 years of age; Pfizer’s vaccine is suitable for use by young children.
The quickest way to return to normal life is by getting vaccinated right now. Marks wrote that if we truly want that, then we should get vaccinated right now.
As a result of the faster process, vaccine makers first requested emergency use authorization, but subsequent studies of the safety and efficacy of the shots have been conducted, and millions of doses have been administered since vaccine rollout began late last year.
Schools and some businesses have already stated they will require the Coronavirus shots. Aside from the vaccine’s full approval, these businesses and schools might also implement this strategy. There are also possibilities for those who resent vaccines to be persuaded.
One-third of the adults surveyed by the Kaiser Family Foundation were not yet vaccinated, and 16% said the vaccine was too new, not tested enough, or too unknown. To better understand public concerns regarding receiving a COVID-19 vaccine, KFF conducted open-ended interviews with a nationally representative sample of adults as vaccine distribution began in the United States in 2021.
In a six-month follow-up, we contacted these individuals to find out whether they chose to receive the COVID-19 vaccine, the reasons for their choice, and their feelings regarding their decision.
Dr. Vivek Murthy said Friday that the vaccine has already been administered to millions around the world, with the approval setting an incentive for some to get vaccinated. A vast majority of the US population — 48.3% of people — are fully immunized against Covid-19, according to the US Centers for Disease Control and Prevention.
In a Washington Post presentation, he mentioned that FDA approval may make a difference for some people, but he thinks they have a lot of experience, a lot of knowledge, that tells them, again, the benefits of this vaccine far exceed any possible risks.
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