The EU says its own procedure has been more thorough
Anthony Fauci, the top US infectious diseases expert, and the EU have criticised UK regulators for the swift approval of Pfizer and BioNTech’s Covid-19 vaccine, after the authorisation was announced in London on Wednesday.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said it had conducted a thorough assessment of the vaccine before granting its emergency use.
“You know I love the Brits, they’re great, they’re good scientists, but they just took the data from the Pfizer company and instead of scrutinising it really, really carefully, they said OK, let’s approve it, that’s it, and they went with it,” Fauci said.
He said the US Food and Drug Administration was the regulatory gold standard and that the agency was assessing the vaccine data carefully, which he called appropriate.
“Because if we did anything that was cutting corners and rushing, we have enough problems with people being sceptical about taking a vaccine anyway,” Fauci said.
The scepticism comes from a significant proportion of Americans who reject medical science, as well as from those wary of the safety of vaccines developed at record speed.
“If we had jumped over the hurdle here quickly and inappropriately to gain an extra week or a week and a half, I think that the credibility of our regulatory process would have been damaged,” Fauci added.
The EU also questioned Britain’s rapid approval of the vaccine, saying its own procedure was more thorough. The European Medicines Agency (EMA) said its longer approval procedure was more appropriate as it was based on more evidence, reports said.
“We could have chosen that way too, but we consciously decided against it,” Germany’s health minister Jens Spahn said.
In response to criticism, the MHRA issued a statement saying that it had “rigorously assessed the data in the shortest time possible without compromising the thoroughness of our review”.
The regulator also said its emergency approval had allowed “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”.
Fauci is the most high-profile member of the White House coronavirus task force and has often clashed with President Donald Trump on how to protect Americans from the virus. He was due to meet members of president-elect Joe Biden’s team on Thursday.