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Criticisms of the speed with which the UK approved the first coronavirus vaccine are “wrong”, said a former regulator, 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 Healthcare Products Regulatory Agency (MHRA), was responding to comments from Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases. .
Dr. Fauci criticized regulators who acted “quickly” and “superficially”, saying that the United States had “the gold standard of a regulatory approach.” By comparison, he said: “The UK didn’t do it so carefully.”
But Professor Evans, a 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 does not necessarily know all the details of the MHRA procedures,” said Professor Evans.
“I respect him enormously … but he is not a regulator, he is a researcher … His criticism, I don’t think, has much validity.”
When asked why he thought Dr. Fauci had made his statement, Professor Evans said: “I imagine it is because there has been criticism of [American regulator] the FDA is slower than the MHRA in evaluating this particular vaccine. But that’s been the kind of complaint that’s been made for a long time, that one regulator or another hasn’t been quick enough to get things done. “
On Wednesday, the UK became the first Western country to license a coronavirus vaccine, but the pace of its regulatory approval process has drawn some criticism, with suggestions that it was speeding up rather than gaining the public’s trust.
Professor Evans said the vaccine regulatory process had been greatly accelerated in all countries by the decision to conduct ongoing reviews that looked at data from clinical trials as they were being conducted.
But even though it was still operating under EU law, he said, Brexit was still a benefit for the MHRA, because the regulator, which previously provided a substantial contribution to the European Medicines Agency, was no longer working for Europe. .
Health Secretary Matt Hancock claimed that the authorization of the vaccine had been possible “due to Brexit”, although it was actually done under EU law.
“My own theory is that because we left the EU system about 18 months ago and stopped working for Europe, we have people in the regulatory authority, who until January have some free capacity,” said Professor Evans.
“The MHRA probably won’t like to admit it, but because of this period of limbo 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 UK at the moment, they have this space. to breathe “.
However, Professor Evans cautioned that the respite would end once the transition period is over, saying that ‘once we enter 2021 there will be no capacity available so the UK may be a bit slower in the future”.
When asked if the US FDA represented the “gold standard” for regulators, as Dr. Fauci claimed, Professor Evans said the “only key difference” between it and other regulators was that it tended to request all data from trials to pharmaceutical companies so that it can be retested.
But he said, “It’s just a higher standard, if it gives you different conclusions.”
“Almost all the differences in the conclusions are related to the interpretation of the data rather than the actual numbers,” he added, although he admitted that they were.
The MHRA has also been criticized for its speed by the European Medicines Agency (EMA), which suggested that its slower approach was more likely to win the public’s trust.
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Today it emerged that the EMA and the World Health Organization (WHO) had asked the MHRA to see the data it had used to evaluate the Pfizer vaccine.
“This decision is a big decision by any of the national regulatory authorities because it will instill confidence in the system,” said Dr. Siddhartha Sankar Datta, director of the Immunization and Vaccine Preventable Diseases program at WHO Europe.
“The entire population will be receiving this vaccine, so it is extremely important that this process is robust, that this process is based on evidence and that this decision is made and shared in a transparent way.”
