Fauci Apologizes For UK Vaccine Comments
“I have a great deal of confidence in what the UK does both scientifically and from a regulator standpoint,” Dr Fauci told the BBC on Thursday.
“Our process is one that takes more time than it takes in the UK. And that’s just the reality,” he said. “I did not mean to imply any sloppiness even though it came out that way.”
The UK’s medicines regulator, the MHRA, claimed it had ‘rigorously assessed the data in the short time possible, without compromising the thoroughness of the review’, as well as reviewing preliminary data on the vaccine trials dating back to June. The MHRA also said that they had been conducting a ‘rolling review’ since October which has helped speed up the process.
“Our Covid vaccines were being developed in a coordinated way that allows some stages to this process to happen in parallel to condense the time needed, but this does not mean that the expected standards of safety, quality and effectiveness have been bypassed,” the regulator said.
“Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency,” it said.
“No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met,” the MHRA added.
Dr Fauci last week told Fox News that he did not believe that the UK had reviewed the vaccine ‘as carefully’ as US health regulators, although he was quick to highlight that it would not be long before America was in a position to approve a vaccine themselves. “We’ll be there. We’ll be there very soon,” he was keen to add.
Later in the week, Fauci said to CBS News that the UK had ‘rushed’ the approval, but after his comments attracted a lot of media attention on both sides of the Atlantic he was quick to walk back the comments, saying he had intended ‘no judgement on the way the UK did it.’
The UK’s first consignment of their Pfizer/BioNTech vaccine order (40 million doses) has now arrived in the country and rolling out will begin next week. The doses were initially transported to a central hub at an undisclosed location and the process of transporting the vaccines, which have to be kept at temperatures of -94F, is currently underway in order to ensure hospital vaccination centres are prepared to start administering their first doses on Tuesday.
Professor Jonathan Van-Tam, the UK’s deputy chief medical officer, said that the first wave of vaccinations could prevent up to 99% of Covid-19 hospital admissions and deaths.
Fauci has declared the US vaccine approval process, slower than the UK’s, the world’s ‘gold standard’. An independent expert on the use and effects of drugs in populations, Professor Stephen Evans of the London School of Hygiene and Tropical Medicine, said that the processes used by the FDA and MHRA to authorize new drugs were ‘basically very similar.’
“The only major difference is that the FDA may reproduce all the tables submitted by a company by re-analysing the data,” he said.
“It is very clear that the UK assessment of this has followed all the usual processes, but has been working incredibly long hours and seven days a week both with MHRA staff and with their academic advisors for quite a long time on initial and interim data before the final data were submitted.”
“America’s Food and Drug Administration does have a different approach to other regulators around the world – it often asks vaccine makers for their raw data, which it then spends time re-analyzing,” BBC health expert Naomi Grimley said.
“The UK’s medicines regulator in London, on the other hand, relies more heavily on the companies’ own reports as does the European Medicines Agency, based in Amsterdam.
“Politics may also explain why the FDA hasn’t yet given the green light. Back in October, President Trump pressured health officials to approve the first vaccine candidates before election day on 3 November but they pushed back, fearing it might become a political football,” she continued.
“The FDA said it wanted to see two months’ extra safety data from the final phase vaccine trials before pharmaceutical companies could apply for emergency approval. That has inevitably left some arguing the US has got bogged down in a much more detailed review than might have been necessary.
“The head of the European Medicines Agency also appeared to raise eyebrows yesterday at the truncated timetable in London,” Grimley continued.
“But officials in the UK believe the US and EU are likely to approve the vaccine soon.”
Harrison Discombe is a Contributing Editor at The National Digest based in the United Kingdom. You can reach him at inquiries@thenationaldigest.com.
