Alok Sharma defends ‘absolutely meticulous’ UK approval process for Covid vaccine

Alok Sharma has defended the “absolutely meticulous” process undertaken by the UK’s independent medicines to provide the green light to a coronavirus vaccine ahead of any other western country.

Mr Sharma said he was “confident” all 800,000 doses of an initial batch would be in the UK by the start of next week.

Insisting the public should “feel confident” about the vaccine, the cabinet minister said the Medicines and Healthcare products Regulatory Agency (MHRA) was regarded as the “gold standard of regulators around the world by scientists”.

“If it wasn’t [safe] it wouldn’t have been approved and wouldn’t have got clearance from the MHRA,” the business minister told BBC Breakfast.

The remarks from Mr Sharma came after the most senior infectious disease expert in the United States suggested Britain’s regulator had not been careful in scrutinising vaccine trial data and rushed through approval.

Dr Anthony Fauci, the director of the National Institute for Allergy and Infectious Diseases had suggested America’s own regulator was conducting a more rigorous review of the jab, claiming the UK “kind of ran around the corner of the marathon and joined in the last mile”.

However, he later apologised for the “misunderstanding” adding he had “great faith” in the MHRA that approved the Pfizer/BioNTech jab on Wednesday in a landmark moment in the fight against Covid-19.

Dr Fauci told the BBC he did “not mean to imply any sloppiness, even though it came out that way”, saying: “I have a great deal of confidence in what the UK does both scientifically and from a regulatory standpoint.”

Asked about his remarks, a spokesperson for the prime minister told reporters at a No 10 briefing on Friday: “You will have seen that he has now withdrawn those comments and apologised.”

“I would just point to the fact the MHRA is a world leader in its field and has followed rigorous international standards in terms of its assessment of the vaccine to ensure it meets the standards of safety and effectiveness and quality. The CEO of the MHRA has been quite clear that no corners have been cut at all.”

The MHRA was also forced to defend its review, insisting it had “rigorously assessed the data” relating to the vaccine “in the shortest time possible, without compromising the thoroughness of our review”.

In a statement, the regulatory body said it started reviewing data in October, adding: “Covid-19 vaccines, including this one, are being developed in a coordinated 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.”

“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 Department of Health and Social Care said the MHRA was a “world leader” in its field and “followed rigorous international standards in its assessment of the Pfizer/BioNTech vaccine to make sure it meets strict standards of safety, effectiveness and quality”.

It is expected that the US Food and Drug Administration (FDA) will meet with representatives from Pfizer and Moderna, who have also developed a vaccine for the virus, on 10 December to discuss the companies’ emergency approval applications.

The European Medicines Agency (EMA) is also considering approval of the jabs for member states and is expected to decide by 29 December whether to give the green light to the first Covid-19 vaccine.

Reiterating comments made by the health secretary, Matt Hancock, Mr Sharma said that the “bulk” of vaccine rollout among priority groups listed by the Joint Community on Vaccination and Immunisation (JCVI) would take place in 2021.

Jabs have already started arriving in Britain from the manufacturing facility in Belgium and the minister insisted an initial 800,000 doses would arrive by next week to kick-off the mammoth task of vaccinating priority groups.

Ministers are also hoping a second vaccine developed by the University of Oxford and AstraZeneca will be approved by the regulator. The government has ordered 100 million doses of the jab, which would considerably boost supplies in the new year.

“We will expect more (Pfizer vaccine) by the end of the year but what we have always said is that the bulk of the vaccination programme will take place next year,” Mr Sharma told BBC Radio 4’s Today programme.

He added: “We've, of course, got the Pfizer/BioNTech vaccine that we’re talking about for deployment right now but AstraZeneca is also being reviewed by the MHRA.

“We'll see what they pronounce and then, of course, we’ve got 100 million of those on order, and a lot of that is being manufactured – and the fill and finish – in the UK.”