FDA approves Pfizer booster for elderly, others at high risk

On Sep 23, 2021

The United States Food and Drug Administration has authorised the use of boosters of Pfizer’s COVID-19 vaccine for people aged over 65, as well as adults at high risk of severe disease and those in high-exposure jobs.

This was disclosed by the acting head of the Food and Drug Administration, Janet Woodcock, in a statement on Wednesday.

This means a significant part of the population – amounting to tens of millions of Americans – are now eligible for a third shot six months after their second.

“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 Woodcock.

The decision was expected and came after an independent expert panel convened by the regulatory agency last week voted in favor of recommending the move.

The panel, however, rejected an initial plan by the White House to fully approve Pfizer boosters to everyone aged 16 and over, in what amounted to a rare rebuke of President Joe Biden’s administration.

The group of vaccinologists, infectious disease specialists and epidemiologists concluded that the benefit-risk balance differed for younger people, especially young males who are more susceptible to myocarditis.

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Food and Drug Administration