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NIAID chief back-pedals on criticism of UK's Pfizer vaccine approval process

Anthony Fauci apologised for previous comments in BBC interview

The director of the US National Institute of Allergy and Infectious Diseases (NIAID) Dr Anthony Fauci (pictured above) has apologised after previously commenting that the UK’s approval process for Pfizer/BioNTech’s COVID-19 vaccine was “rushed”.

The UK became the first country in the world to approve Pfizer/BioNTech’s COVID-19 vaccine BNT162b2 earlier this week, with its Medicines and Healthcare Products Regulatory agency (MHRA) granting the vaccine an emergency use authorisation on Wednesday.

In an interview with CBS News yesterday, Dr Fauci expressed criticism over the rapid speed at which the vaccine was approved in the UK.

"They kind of ran around the corner of the marathon and joined it in the last mile," Dr Fauci told CBS News. "They really rushed through that approval,” he added.

In response to questions over the US Food and Drug Administration’s (FDA) handling of the regulatory process for the vaccine, Dr Fauci added that "they're doing it in a very careful way, appropriately”.

"Because if we did anything that was cutting corners and rushing –  we have enough problems with people being skeptical about taking a vaccine anyway –  if we had jumped over the hurdle here quickly and inappropriately to gain an extra week or a week and a half I think that the credibility of our regulatory process would have been damaged," he added.

Dr Fauci was not alone in his criticism of the UK’s approval process – the European Medicines Agency (EMA) told Reuters that its longer approval process was ‘more appropriate’, as it is based on more evidence and also requires more checks compared to the UK’s decision-making process.

Following his earlier comments, Dr Fauci told the BBC in a live interview last night that he has “a great deal of confidence in what the UK does both scientifically and from a regulator standpoint”.

"Our process is one that takes more time than it takes in the UK. And that's just the reality. I did not mean to imply any sloppiness even though it came out that way,” he added.

The FDA announced in November that it had scheduled a meeting on 10 December to discuss the emergency use authorisation request for Pfizer/BioNTech’s vaccine candidate.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is set to meet and discuss the vaccine, as well as make recommendations to the FDA regarding the possible authorisation of the vaccine.

According to Axios, FDA commissioner Stephen Hahn was called to the White House to discuss the agency’s timings for reviewing the vaccine, following its approval in the UK.

"We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It's our job to get this right and make the correct decision regarding vaccine safety and efficacy,” Hahn told Axios.

Article by
Lucy Parsons

4th December 2020

From: Regulatory

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