The UK’s medicines regulator has defended itself against criticism from America’s top infectious disease expert, saying it has “rigorously assessed the data” for the Pfizer/BioNtech Covid-19 vaccine.
The Medicines and Healthcare products Regulatory Agency (MHRA) commented after Dr Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, warned the speed at which the UK approved the Pfizer/BioNTech vaccine could undermine confidence in the jab.
Dr Fauci told CBS American regulators would do a “more thorough job” – although he later backed away from the comments, saying he was not implying sloppiness on the part of British authorities, in whom he had “great faith”.
The MHRA said it had carefully assessed all the data on the vaccine and no “standards of safety, quality and effectiveness have been bypassed”.
The development of the @Pfizer/@BioNTech_Group #COVID19 vaccine involved overlapping clinical trials to save time.
Listen to Dr June Raine, CEO of @MHRAgovuk, describe this process ⬇️
Read more:
▶️ https://t.co/8y4rXsVdPs— Department of Health and Social Care (@DHSCgovuk) December 3, 2020
The UK has ordered 40 million doses of the Pfizer jab, enough to vaccinate 20 million people. The first doses arrived on Thursday, with rollout in the UK starting on Tuesday.
Defending itself after Dr Fauci’s comments, the MHRA insisted it had “rigorously assessed the data” relating to the vaccine “in the shortest time possible, without compromising the thoroughness of our review”.
It added: “Covid-19 vaccines, including this one, are being developed in a co-ordinated way that allows 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.”
It added a rolling review of the vaccine data started at the beginning of October, and the agency said it had made good progress on the review before the last submission of data was received.
“Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines and Healthcare products Regulatory Agency.
“No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.”
