The Food and Drug Administration (FDA) could approve Pfizer-BioNTech's two-dose Covid-19 vaccine on Monday, further accelerating the immunization licensing timeline.
So reported 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 warned the newspaper that approval could happen 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 approved Monday, it would mean an acceleration of nearly two weeks.
The approval of the Pfizer-BioNTech vaccine could be an incentive for millions of people eligible for immunization and still hesitant to get inoculated to roll up their sleeves and accept their doses.
Recent surveys suggested that many people have been reluctant to accept the vaccine because it has not yet been fully approved by the FDA, as it maintained an emergency use status.
In that sense, the news would come in the midst of a significant increase in COVID-19 cases due to the Delta variant, in addition, there are more and more unvaccinated children over 12 years old, and 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 granted.
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 Sept. 20.
Meanwhile, the drugmaker could finish sending data showing that a third injection is safe and effective next week.
Advances in the use of third doses have moved quickly, as just last week, the FDA updated its approvals of the Pfizer-BioNTech and Moderna vaccines in immunocompromised people, such as those who have received a transplant. The Centers for Disease Control and Prevention approved that decision.
Pfizer-BioNTech's application to the FDA for approval of the vaccine is followed by Moderna's application, which could come a few months later.
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