COVID: US FDA authorises Pfizer booster shots for elderly, at-risk Americans

The United States Food and Drug Administration (FDA) has approved booster shots of the Pfizer COVID-19 vaccine for the elderly and high-risk adult in America. According to ANI, the highly-anticipated decision came after ascertaining the benefit-risk balance in a meeting involving the regulatory agency and an independent panel to vote on the decision. The announcement regarding the approval was made on Wednesday, 22 September through a press release by the US administration.

"The emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (will be allowed) for use of a single booster dose, to be administered at least six months after completion of the primary series," the release mentioned. The primary series includes all individuals 65 years of age and older; individuals 18 through 64 years of age at high risk of severe COVID-19; and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe cases. The authorisation announcement indicated that a major part of the US population will now be eligible for third shots.

“Today’s action demonstrates that science and the currently available data continue to guide the FDA’s decision-making for COVID-19 vaccines during this pandemic," said Dr. Janet Woodcock, Acting Commissioner of the FDA. She also added that the decision was taken "after considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts." The FDA also amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow booster doses for health care workers, teachers, and daycare staff, grocery workers and for those residing in homeless shelters or prisons, among others, the statement added.

About 22 million Americans will be eligible for the Pfizer-BioNTech COVID booster jab, according to a bulletin released by the Center for Disease Control and Prevention (CDC). More than half of them are above 65 years of age. However, those administered with Moderna and Johnson & Johnson doses will have to wait since the FDA is yet to release a decision on the booster shots.

Meanwhile, the implementation of Pfizer's COVID booster plan now awaits a nod from the CDC. The regulatory board is currently in the middle of a two-day meeting on the issue, ANI reported. Although, Pfizer-BioNTech can still offer vaccinations since they met the FDA criterion.

(With inputs from ANI)

(Image: AP)