COVID-19 vaccine doses now destined for the U.K. market are being produced at this factory in Puurs, Belgium.
kenzo tribouillard/Agence France-Presse/Getty Images
The reason the U.K. was the first Western country to approve the Pfizer–BioNTech vaccine is that it is a “much better country” than the United States, a leading government minister has claimed.
“I just reckon we’ve got the very best people in this country, and we’ve obviously got the best medical regulator, much better than the French have, much better than the Belgians have, much better than the Americans have,” Gavin Williamson, education secretary in the Boris Johnson cabinet (and a former defense secretary), said in an interview on LBC Radio. “That doesn’t surprise me at all because we’re a much better country than every single one of them.”
The controversial comments are likely to inflame international relations.
The European Medicines Agency, or EMA, the regulator charged with approving vaccines for the European Union, said its procedures were based on more evidence and required more checks than the emergency procedure chosen by the U.K.
But U.K. health secretary Matt Hancock said the EMA, which had been forced to relocate from London to Amsterdam last year, had lost staff and suffered budget constraints, causing it to have “major difficulties” coping with the pandemic.
Hancock also credited Brexit, the U.K.’s separation from the European Union, for the country’s speed in authorizing the vaccine, telling Times Radio: “Because of Brexit we’ve been able to make a decision to do this based on the U.K. regulator … and not go at the pace of the Europeans, who are moving a little bit more slowly.
“We do all the same safety checks and the same processes, but we’ve been able to speed up how they’re done because of Brexit.”
Another senior politician, Jacob Rees-Mogg, said on Twitter: “We could only approve this vaccine so quickly because we have left the EU.”
However, when he was asked, Prime Minister Boris Johnson would only say: “These are global efforts [in which] you’ve got scientists around the world coming together to make this possible.”
On Thursday, Dr. Anthony Fauci, the top infectious-diseases expert in the U.S., said in a television interview that it wasn’t a race. He faulted the U.K. for not having been as careful as the U.S.
Read: Dr. Fauci slams U.K. for rushing Pfizer coronavirus vaccine approval
“The U.K. has decided to do it a little bit differently, they’ve gone over it very quickly,” he said on a Sky News broadcast. “And I can say — and this is not a criticism, but they’ve done it in a way that is much less deep than has been done, and is being done by the FDA [Food and Drug Administration] in the United States. The FDA in the United States, I think, everyone realizes globally is the gold standard of regulatory function.”
Former medical regulator Stephen Evans of the London School of Hygiene and Tropical Medicine told the Times that Dr. Fauci was not a regulatory expert and suggested he made his initial comments “because there’s been criticism of the FDA being slower than the MHRA [the U.K.’s Medicines and Healthcare products Regulatory Agency].”
On social media, some accused Fauci of sour grapes, while pointing out that the virus is “totally out of control” in the U.S.
Fauci later took to the BBC to apologize for a “misunderstanding,” saying he did not mean to imply the U.K. regulator had been sloppy, and he qualified his comments:
On Wednesday, Dr. June Raine, chief executive of MHRA, insisted no corners had been cut.
“The public can be absolutely confident that every rigorous check has been done to reach the judgment that we reached, that the benefits far outweigh any risk, but the safety of the vaccine has been scrutinized independently by our Commission on Human Medicines, and no stone has been left unturned,” she said at a press conference.
“This vaccine has only been approved because those strict tests have been done and complied with, and everyone can be absolutely confident that no corners whatsoever have been cut,” she added.
Read: Who will be given priority for the Pfizer-BioNTech COVID-19 vaccine?
Up until the end of the year, the EMA still has the power to authorize drugs in the U.K., with the U.K. formally severing ties with the EU on Dec. 31, but the U.K. government and MHRA exercised their right to override it, citing an emergency situation.
When the EMA was based in the U.K., it worked closely with the MHRA, delegating to the British agency much of the work of authorizing Europe’s medicines.
Read: Here’s the time line for vaccine approval around the world, as U.K. authorizes COVID-19 shot
One of the reasons given for the MHRA’s capacity to act so fast in authorizing the vaccine from U.S. drug manufacturer Pfizer PFE, +0.62% and German partner BioNTech BNTX, +1.11% 22UA, -2.91% is that it has an experienced team of 1,200 scientists routinely scrutinizing the safety of these types of vaccines.
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