UK drug regulator defends rapid pace of vaccine approval – Manila Bulletin

Britain’s drug regulator insisted on Friday that its first global approval of the Pfizer-BioNTech coronavirus vaccine met all safety standards, after officials in Europe and the United States raised questions about the speedy process.

Britain announced on Wednesday that it had given emergency approval for the vaccine’s general use and would start rolling it out next week.

“Any vaccine must undergo robust clinical trials in accordance with international standards, with oversight provided by the Medicines and Health Products Regulatory Agency,” the MHRA regulator said in a statement.

“No vaccine would be authorized to supply in the UK unless expected standards of safety, quality and efficacy are met,” said the Medicines and Healthcare Products Regulatory Agency.

Anthony Fauci, a leading American infectious disease scientist, said Thursday that the MHRA had “rushed to approve that approval” but later apologized.

“I am very confident in what the UK is doing both scientifically and from a regulatory point of view,” Fauci, who heads the US National Institute of Allergy and Infectious Diseases, told the BBC.

“Our process is one that takes longer than it takes in the UK. And that’s just the reality, “he said, adding,” I didn’t mean to hint at any oversights even though it came out that way. “

Britain plans to distribute an initial batch of 800,000 doses starting next week, giving priority to nursing homes.

MHRA CEO June Raine previously insisted that “no corners had been cut” in the Pfizer-BioNTech vaccine research.

With Britain’s transition out of the European Union, the UK regulator obtained a waiver from the EU drug agency, which has emphasized that it prefers to wait for further reviews and consultations across the bloc.

The MHRA said it was able to move quickly after launching an ongoing review of the data provided by Pfizer and BioNTech as the human trials progressed, rather than waiting for all the data to be collected at the end of the trials.

“The Covid-19 vaccines, including this one, are being developed in a coordinated manner that allows some stages of this process to happen in parallel to condense the necessary time, but it does not mean steps and the expected standards of safety, quality and effectiveness have been passed. overlooked, ”it said.

Approval is expected this month from both the US Food and Drug Administration and the European Medicines Agency.

England’s deputy chief medical officer, Jonathan Van-Tam, also responded to critics, suggesting bitter grapes by regulators that they are subject to more cumbersome procedures.

“If you are a regulator who is a little more behind, what do you say to justify your position that you are more behind? Words like the ones we may have heard, ”he told the BBC on Wednesday.

Some British ministers have drifted into anti-EU patriotism after London beat Brussels to approve the Pfizer / BioNTech coup.

But Van-Tam also highlighted the international nature of scientific collaboration.