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Regulator defends speed of UK vaccine approval as first batch arrives

Regulator defends speed of UK vaccine approval as first batch arrives

The UK approved a Covid-19 vaccine without compromising safety, the medicines regulator said after America’s top infectious disease expert questioned the level of scrutiny. Dr Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, warned the speed at which the UK approved the Pfizer/BioNTech vaccine could undermine confidence in the jab.

 

Dr Fauci told CBS American regulators would do a “more thorough job”, although he later backed away from the comments, saying he was not implying sloppiness on the part of British authorities, in whom he had “great faith”.

However with the first doses of the vaccine now believed to have arrived in the UK, there was still confusion over who would receive it first, with Scotland planning to deliver the jabs into care homes from December 14, but NHS England not committing to a date.

The comments came as the coronavirus death toll in the UK passed the 60,000 mark, jumping to 60,113 after a further 414 fatalities were announced on Thursday.

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.

The Medicines and Healthcare products Regulatory Agency (MHRA) said: “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 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 a rolling review of the vaccine data started at the beginning of October, and the agency said it 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 Times reported MHRA head June Raine will conduct a round of interviews with regional radio stations in an attempt to convince people concerned about the vaccine, believing people are more likely to trust what they hear on local radio.

Dr Fauci told CBS News that Britain “kind of ran around the corner of the marathon and joined it in the last mile” adding: “They really rushed through that approval.”

“The FDA, the United States of America Food and Drug Administration, is the gold standard of regulation,” he said.

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

He warned the speed of the approval could damage confidence, 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.”

But in a later interview with BBC News, Dr Fauci said he did not mean to “imply any sloppiness”, adding: “I do have great faith in both the scientific community and the regulatory community at the UK.”

The World Health Organisation (WHO) offered a toned down response to the MHRA decision, simply stating the approval had been “acknowledged”.

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.”

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

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

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

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

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

In related news:

– Travel between Wales and some other parts of the UK will be allowed from 6pm on Friday, including to and from Tier 1 and 2 areas of England and Level 1 and 2 areas of Scotland.

– But the Welsh Government says travel is prohibited between Wales and Tier 3 areas of England, Level 3 or 4 areas of Scotland, and the whole of Northern Ireland, which is currently under lockdown.

– The proportion of close contacts reached by England’s Test and Trace system has jumped after contact tracers stopped trying to reach all under-18s individually – but more than a quarter are still being missed despite the change.

– Facebook has vowed to start removing false claims about new coronavirus vaccines, including misinformation that vaccines contain microchips.

Content provided by Radio NewsHub. Originally published on 2020-12-04 09:09:00.

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