The Food and Drug Administration gave full clearance to Pfizer and BioNTech's COVID-19 vaccine on Monday, making it the first in the United States to get the full approval.
The U.S. FDA granted full authorization to Pfizer-BioNTech COVID-19 vaccine.
FDA Scientists Evaluated Data from Pfizer
In a recently published article in CNBC, according to the FDA, scientists reviewed "hundreds of thousands of pages" of vaccination data from 40,000 study participants. The vaccine was shown to be 91 percent efficient in preventing COVID, which was somewhat lower than the 95 percent effectiveness rate trial data indicated when the injection was approved late last year and before the delta version gained traction in the United States.
Acting FDA Commissioner Janet Woodcock said in a statement that Pfizer's vaccine satisfied the agency's rigorous criteria for safety, efficacy, and manufacturing quality. Meanwhile, millions of individuals have gotten COVID-19 vaccinations successfully, and they acknowledge that the FDA's approval of a vaccine may give some people more confidence to be vaccinated.
Furthermore, since the drugmakers filed their application to the FDA in early May, federal health authorities have been under increasing pressure from the scientific community and advocacy organizations to completely approve Pfizer and BioNTech's vaccine. On May 7, the firms filed a Biologics License Application to the FDA, securing complete approval for patients aged 16 and above, according to a published article in The Washington Post.
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Pfizer's COVID-19 Vaccine is Still Under EUA for Kids Under 12 Years Old
In a published article in NBC San Diego, as the firm continues to gather data, the vaccine is still approved for emergency use in children aged 12 to 15. Dr. Peter Marks, the FDA's chief vaccine regulator, said Monday that after the firm provides the data, the agency would act as "quickly" as possible to approve the injection for children under the age of 12.
Standard vaccination evaluations may take anything from a few months to a year or more to establish if they are safe and effective for widespread usage. However, due to the pandemic, which has claimed the lives of over 628,000 Americans, the FDA granted an EUA allowing the injections to be used.
Meanwhile, Dr. Marks said Because there are still studies underway, the FDA must wait for the business to submit data for those trials. They want to be certain that they get it properly. Marks also debunked myths about the injection, such as that it includes microchips and leads to infertility.
FDA's Full Approval Will Enforce Mandate of Vaccination
Within hours of the news, the Pentagon, CVS, the State University of New York system, and the New York City school system, among others, stated that they would carry out requirements that they had planned to implement but had put on hold pending the FDA's action, according to a report published in MSN News.
The Pentagon was one among the first and biggest to go forward. According to John F. Kirby, a Pentagon spokesman, Defense Secretary Lloyd J. Austin III had already obtained permission from President Biden to require vaccinations for all active-duty soldiers once the vaccine was officially authorized, and he was working quickly to put the plans into effect. 1.4 million military members will get special vaccination instructions from the secretary shortly.
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