Dr Anthony Fauci, the top US infectious disease expert, on December 3 said the UK was not as rigorous as the US health authorities in its COVID-19 vaccine approval process.
The UK on December 2 became the first country in the world to approve the Pfizer/BioNTech vaccine for the coronavirus. “The UK did not do it as carefully,” he told Fox News. “If you go quickly and you do it superficially, people are not going to want to get vaccinated.” “We really scrutinise the data very carefully to guarantee to the American public that this is a safe and efficacious vaccine,” he said.
“We have the gold standard of a regulatory approach with the US Food and Drug Administration (FDA). The UK did not do it as carefully and they got a couple of days ahead,” the 79-year-old expert said.
The Pfizer/BioNTech is the fastest ever vaccine to go from concept to reality, taking only 10 months to follow the same developmental steps of vaccine production, that normally span a decade. The UK has defended its approval process, and said the injection is safe and effective.
Dr June Raine, the head of the UK medicines regulator, on Wednesday said that “no corners had been cut” in screening the vaccine. The Medicines and Healthcare Products Regulatory Agency (MHRA) reviewed preliminary data on the vaccine trials dating back to June. “No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met,” the regulator said.
However Dr Fauci soon walked back the comments and said there was “no judgement on the way the UK did it”. “I have a great deal of confidence in what the UK does both scientifically and from a regulator standpoint.”
Dr Fauci had described the US Food and Drug Administration’s approval process, slower than the UK, as the “gold standard”. He clarified, saying the US does “things a little differently” than the UK.
“That’s all,” he said. “Not better, not worse, just differently.”