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FDA’s approval of Pfizer/BioNTech’s COVID-19 vaccine “is a milestone” says acting FDA commissioner Janet Woodcock

After more than a billion doses have been given worldwide, Comirnaty is now officially approved for people aged 16 and over in the US

The FDA has officially approved the first vaccine for the prevention of COVID-19 disease in individuals 16 years and over: Pfizer/BioNTech’s Comirnaty, after 1.2 billion doses have been delivered to more than 120 countries worldwide.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said acting FDA commissioner Janet Woodcock. “As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product.”

With many of those who are vaccine hesitant citing the lack of official FDA approval as a key reason for not accepting the vaccine, Woodcock was keen to reassure people. “While millions of people have already safely received COVID-19 vaccines, we recognise that, for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” she said.

Comirnaty was first approved by the FDA under an emergency use authorisation on 20 December 2020 for those 16 years and over, which was expanded on 10 May 2021 to cover 12-15 year-olds. The EUA remains in force for 12-15 year-olds.

In its announcement, the FDA also addressed several of the other concerns expressed by those who are vaccine hesitant, including worries around the use of messenger RNA. “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material,” stressed the FDA.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.

“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the US,” said Marks.

Albert Bourla, chairman and chief executive of Pfizer, said: “Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed… I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity.”

As announced last week, Pfizer and BioNTech plan to seek a licence for a third, booster shot of Comirnaty in those 16 years and over via a supplemental biologics licence application (BLA). The companies also plan to submit a supplemental BLA to support full use of COMIRNATY for 12-15 year-olds once they have the required six-month data.

Article by
Hugh Gosling

24th August 2021

From: Regulatory, Healthcare



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