COVID-19: Fauci ‘got it wrong’ about UK regulator’s criticism of vaccine approval | Scientific and technical news

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Criticisms of how quickly the UK approved the first coronavirus vaccine are ‘wrong’, a former regulator said, adding that approval was faster in the UK because Brexit gave the regulator a brief moment of “reserve capacity”.

Professor Stephen Evans, who worked on vaccines for the previous incarnation of the Medicines and Health Products Regulatory Agency (MHRA), responded to comments from Dr Anthony Fauci, director of the U.S. National Institute of Allergy and infectious diseases.

Dr Fauci criticized regulators for acting “quickly” and “superficially”, saying the United States had “the gold standard of a regulatory approach”. By comparison, he said: “The UK has not done it so carefully”.

But Professor Evans, who is professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine and an expert in clinical trials, told Sky News that Dr Fauci was “wrong”.

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“I suspect that Dr Fauci may not necessarily know all the details of MHRA procedures,” Professor Evans said.

“I respect him enormously… but he’s not a regulator, he’s a researcher… His criticism, I don’t think, has a lot of validity. ”

When asked why he thought Dr Fauci made his statement, Professor Evans replied: “I imagine it’s because there have been criticisms. [American regulator] the FDA being slower than the MHRA in evaluating this particular vaccine. But this is the kind of complaint that has been made for a long time that one regulator or another was not quick enough to get it right. ”

The UK on Wednesday became the first Western country to allow a coronavirus vaccine, but the pace of its regulatory approval process drew some criticism, with suggestions that it was accelerating public confidence.

Prof Evans said the vaccine regulatory process has been sped up significantly in all countries by the decision to conduct ongoing reviews that examine data from clinical trials while they are being conducted.

But even though it still operated under EU law, he said, Brexit was still an advantage for the MHRA, as the regulator, which previously provided a substantial contribution to the European Medicines Agency, no longer worked for Europe.

Health Secretary Matt Hancock said authorization of the vaccine had been possible “due to Brexit”, although in fact it was done under EU law.

“My own theory is that because we got out of the EU system about 18 months ago and stopped working for Europe, we have people within the regulatory authority who until ‘in January, have reserve capacity,’ said Professor Evans.

“The MHRA probably won’t like to admit it, but because of this unclear period where they don’t have to do all the work for the European agency, and they don’t have to do the work for the Kingdom. -United for the moment. , they have this space to breathe. ”

However, Professor Evans warned that the respite would end once the transition period is over, saying that “once we are in 2021 there will be no reserve capacity, so the Kingdom may -Uni be a little slower. In the future “.

Asked whether the US FDA represents the ‘gold standard’ for regulators, as Dr Fauci claimed, Professor Evans said the ‘only key difference’ between it and other regulators was that ‘she tended to ask the companies for all test data to reanalyze it.

But he said, “It’s only a higher standard, if that gives you different conclusions. ”

“Almost all the differences in the conclusions are about the interpretation of the data rather than the actual numbers,” he added, while admitting that was the case.

The MHRA has also been criticized for its speed by the European Medicines Agency (EMA), which has suggested that its slower approach is more likely to gain public trust.

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It emerged today that the EMA and the World Health Organization (WHO) had asked the MHRA to see the data it used to evaluate the Pfizer vaccine.

“This decision is an important decision on the part of one of the national regulatory authorities, as it will instill confidence in the system,” said Dr Siddhartha Sankar Datta, program manager for vaccine and vaccine preventable diseases at WHO Europe.

“Everyone will receive this vaccine, so it is extremely important that this process is robust, that this process is evidence-based and that this decision is made and shared in a transparent way. ”

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