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COVID-19 Pfizer/BioNTech booster approved by FDA and CDC

The plan to offer Americans a third, booster shot of the Pfizer/BioNTech COVID-19 vaccine has finally been waved through by the FDA and CDC


After months of controversy, the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have given a green light to the COVID-19 booster programme in the US.

The FDA’s decision to extend the emergency use authorisation (EUA) for Pfizer’s Comirnaty vaccine comes just days after it convened a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC).

At the meeting, the programme was approved for high-risk groups but a call to offer booster shots to all Americans were firmly rejected by 16 of the 18 experts.

The FDA has defined the scope of the booster programme, limited its approval to people 65 and older, adults 18 and over who are at high risk of severe COVID-19 and adults over 18 who are at “frequent institutional or occupational exposure to SARS-CoV-2”.

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” said acting FDA commissioner, Janet Woodcock.

The booster shot must be given at least six months after “completion of the primary series”, stipulated the FDA. Comirnaty was fully approved a month ago for all adults 16 years and older.

Given the controversial nature of the issue, the FDA has gone to great lengths to give the process as much transparency as possible, including opening the meeting of the VRBPAC to the public and inviting expert groups to participate, including the Israeli Ministry of Health, the University of Bristol in the UK and the CDC.

However, the controversy around the booster programme may not be over after CDC head, Rochelle Walensky, overruled her advisory panel to back the programme.

Earlier this week, an advisory panel to the agency failed to recommend the booster for people in high-risk jobs, such as teachers, and those in risky living conditions, although it did recommend boosters for older people and those with underlying medical conditions.

“In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good,” said Walensky. “I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19. This aligns with the FDA’s booster authorisation and makes these groups eligible for a booster shot.”

Article by
Hugh Gosling

24th September 2021

From: Regulatory



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