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FDA may approve two-dose Pfizer-BioNTech vaccine on Monday

FDA May Approve Pfizer Vaccine

The Food and Drug Administration (FDA) could approve Pfizer-BioNTech's two-dose Covid-19 vaccine this Monday, which would further accelerate the timeline for licensure of the immunization.

This was reported by the New York Times, which detailed that regulators were working Friday to finalize the process. However, it said, they were still working on a substantial amount of paperwork and negotiations with the company. 

People who have been involved with planning the vaccine approval have not made a public statement. However, they cautioned the newspaper that approval could pass after Monday if some components of the review need more time.

Initially, the FDA said approval of the vaccine could have been around Labor Day, and if approval is given this Monday, it would mean an acceleration of almost two weeks.

The approval of the Pfizer-BioNTech vaccine could be an incentive for millions of people eligible for immunization and still hesitant about getting inoculated to roll up their sleeves and accept their doses.

Recent surveys suggested that many people have refused to accept the vaccine because it has not yet had full FDA approval, as it maintained an emergency use status.  

In this regard, the news comes amidst a significant increase in COVID-19 cases due to the Delta variant, in addition, there are more and more unvaccinated children over 12 years of age who have presented severe disease.

In addition, approval could result in some universities and hospitals requiring inoculation once the vaccine is fully approved. 

Recently, the Pentagon said it is considering making COVID vaccines mandatory for the nation's 1.3 million active-duty soldiers no later than the middle of next month, or sooner if FDA approval is given.

Moreover, once approval is granted, Pfizer-BioNTech will apply to the FDA for approval of a third dose as a booster injection. 

This Wednesday, the federal government announced that fully vaccinated adults should prepare to receive booster shots eight months after receiving their second doses, beginning September 20. 

Meanwhile, the drugmaker could finish submitting data showing that a third injection is safe and effective next week.

Advances in the use of the third doses have advanced rapidly, as just last week, the FDA updated its approvals of the Pfizer-BioNTech and Moderna vaccines in immunocompromised individuals, such as those who have received a transplant. The Centers for Disease Control and Prevention approved the decision.

Pfizer-BioNTech's application to the FDA for FDA approval of the vaccine is followed by Moderna's application, which could follow a few months later.

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Pamela Cruz
Pamela Cruz
Editor-in-Chief of Peninsula 360 Press. A communicologist by profession, but a journalist and writer by conviction, with more than 10 years of media experience. Specialized in medical and scientific journalism at Harvard and winner of the International Visitors Leadership Program scholarship from the U.S. government.

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