FDA panel debates authorisation of Pfizer/BioNTech vaccine

FDA panel debates authorisation of Pfizer/BioNTech vaccine


The US took a step closer towards a decision on the Pfizer/BioNTech Covid-19 vaccine on Thursday, as a committee of experts began deliberations about whether it would recommend that the jab receive emergency authorisation.

After an all-day meeting of scientists on the Vaccines and Related Biological Products Advisory Committee, the panel will take a vote on a single question: whether or not the benefits of the Pfizer/BioNTech vaccine outweigh its risks for use in individuals 16 years of age and older. 

It will also discuss whether there are any gaps in the evidence that Pfizer/BioNTech has provided and if and when the placebo group in the trial should be vaccinated.

Ahead of the meeting, Stephen Hahn, the head of the US Food and Drug Administration, which will take the final decision over whether to release the vaccine for public use, promised to make a decision soon after the committee’s recommendation.

Dr Hahn said in a statement: “In this time of great urgency, FDA staff feel the responsibility to move as quickly as possible through the review process.

“However, they know that they must carry out their mandate to protect the public health and to ensure that any authorised vaccine meets our rigorous standards for safety and effectiveness that the American people have come to expect.”

Separately, he told NBC News: “Our initial assessment is that this is a vaccine that does meet our criteria . . . But we do want to hear from the vaccine advisory committee.”

The vaccine has so far been authorised in the UK, Canada, Bahrain and Saudi Arabia.

The FDA said earlier this week that trial data backed up Pfizer’s assertion that its vaccine had an efficacy rate of 95 per cent on average, and began working about 10 days after the first of two doses had been administered.

Based on that information, the UK last week became the first country to give the go-ahead for inoculations to start. Margaret Keenan, 90, and William Shakespeare, 81, became the first people to receive the injections outside of the trial process.

At the same time, the New England Journal of Medicine published the results of Pfizer/BioNTech’s phase 3 trial data, the first time it has been printed in a peer-reviewed journal.

It confirmed that the vaccine had a similar efficacy rate across all groups of age, race, ethnicity, weight and underlying chronic conditions. The authors concluded that the safety profile — studied for an average of two months after vaccination — was similar to other viral vaccines.

The paper said there was one case of severe Covid-19 in the vaccination group, compared with nine in the placebo group. The committee is likely to want to discuss why that one participant became seriously ill, as well as a couple of cases of allergic reactions seen in the UK this week.

In a separate editorial in the same journal, Eric Rubin, an immunologist at Harvard University and a member of the FDA advisory committee, called the results a “triumph”.

He wrote: “Most vaccines have taken decades to develop, but this one is likely to move from conception to large-scale implementation within a year.”

The meeting comes as the pandemic’s toll on the US continues to worsen, with infections and hospitalisations hovering at record highs. On Wednesday, the country recorded more than 3,000 coronavirus deaths for the first time ever.



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