International community raises questions over speed of UK vaccine approval

Dr Anthony Fauci claimed American regulators “would do a more thorough job” of assessing the vaccine developed by Pfizer/BioNTech
International community raises questions over speed of UK vaccine approval

Vial of the Pfizer/BioNTech vaccine (BioNTech SE 2020/PA)

The international community has raised eyebrows over how quickly the UK approved a Covid-19 vaccine, with America’s top infectious disease expert questioning the level of scrutiny.

Dr Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, claimed American regulators “would do a more thorough job” of assessing the vaccine developed by Pfizer/BioNTech.

The World Health Organisation (WHO) offered a toned down response to the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision, simply stating the approval had been “acknowledged”.

The comments came as the coronavirus death toll in the UK passed the 60,000 mark, jumping to 60,113 on Thursday.

(PA Graphics)

Dr Fauci told CBS News that Britain “kind of ran around the corner of the marathon and joined it in the last mile”.

He added: “They really rushed through that approval.”

Dr Fauci said: “The FDA, the United States of America Food and Drug Administration, is the gold standard of regulation.

“They are doing it in a careful way, appropriately.”

He warned that the speed at which the UK has approved the Pfizer vaccine could undermine confidence in the jab, telling Sky News: “When we did a survey here in the US, there was a considerable degree of scepticism and reluctance to get vaccinated and we were concerned that if we did anything that looked like it was cutting corners that would feed into the scepticism.”

In response to the comments, the MHRA said in a statement: “We have rigorously assessed the data in the shortest time possible, without compromising the thoroughness of our review.

“Covid-19 vaccines, including this one, are being developed in a co-ordinated in a way that allows some stages of this process to happen in parallel to condense the time needed, but it does not mean steps and the expected standards of safety, quality and effectiveness have been bypassed.”

It added that a rolling review of the vaccine data started at the beginning of October, and since then the data, and had made good progress on the review before the last submission of data was received.

“Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency.

“No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met,” the statement concluded.

Dr Siddhartha Sankar Datta, WHO regional adviser for vaccine-preventable diseases and immunisation in Europe, said: “The national regulatory authority of a country will review the different elements of a system before they make the vaccine licensed for use – (based on) the safety, efficacy and quality of the vaccine.

“That is what the UK’s national regulatory authority has done yesterday with their evaluation. We have learned about it and we acknowledge it.”

And the European regulator has criticised the approval of the vaccine using emergency powers, insisting that its own, slower approach is more appropriate.

Despite this criticism, a British Cabinet minister declared the UK is getting a coronavirus vaccine first because it is a “much better country” than France, Belgium and the US.

The UK's Education Secretary Gavin Williamson praised the work done by the medical regulator to approve the Pfizer/BioNTech vaccine for use.

The first doses of the vaccine are now believed to have arrived in the UK.

The UK has ordered 40 million doses of the Pfizer jab, enough to vaccinate 20 million people, with 800,000 doses expected to arrive by next week.

Issues surrounding storage temperature and how many times it can be transported have prompted the Prime Minister to warn of “immense logistical challenges” in the Pfizer rollout, with experts saying that people in care homes might face a delay in receiving immunisation from the disease.

However, the Scottish Government has said care homes in the country will get the jab from December 14, raising questions for care home residents in other parts of the UK.

(PA Graphics)

The Medicines and Healthcare products Regulatory Agency (MHRA) said on Wednesday that batches could be made smaller – the same day the chief executive of NHS England Sir Simon Stevens told a Downing Street press conference that approval was needed for the vaccine to be safely divided.

A document outlining conditions of authorisation said “further packing down” of batches to aid deployment could occur at 2C to 8C within two hours of leaving cold storage.

Scotland’s Health Secretary Jeane Freeman said talks over lunchtime on Thursday had confirmed that the vaccine could be transported in an unfrozen state for up to 12 hours and could also be broken down into smaller packs in “certain conditions”.

NHS England would not commit to a date to roll out the vaccine in English care homes.

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