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UK drug regulators defend the fast pace of vaccine approval

London: UK drug regulators claim Friday that the world’s first approval of the Pfizer-BioNTech coronavirus vaccine meets all safety standards after European and US officials ask questions about the rapid process. did.
The UK announced on Wednesday that it would give urgent approval for the general use of the vaccine and begin rolling out next week.
“Every vaccine must undergo strong clinical trials in line with international standards under the supervision of the Medicines and Healthcare Products Regulatory Agency,” the MHRA regulator said in a statement.
“Unless the expected standards of safety, quality and efficacy are met, the UK will not be allowed to supply vaccines,” said the Medicines and Healthcare Products Regulatory Agency.
Anthony Fauci, a leading US infectious disease scientist, said Thursday that the MHRA “rushed through its approval” but later apologized.
“We are very confident that the UK is doing it both scientifically and from a regulatory perspective,” Forch, who heads the National Institute of Allergy and Infectious Diseases, told the BBC.
“Our process is a process that takes longer than the UK, and that’s the reality,” he added, “even if it came out that way, I didn’t mean to be sloppy.” It was.
The UK will prioritize care homes and will distribute 800,000 initial batches starting next week.
June Raine, CEO of MHRA, previously claimed that “the corners were not cut” during the Pfizer-BioNTech vaccine review.
As the UK moved out of the European Union, UK regulators were exempt from EU pharmaceutical institutions. This emphasizes the preference to wait for further reviews and consultations across the block.
After launching a rolling review of the data provided by Pfizer and BioNTech, MHRA said it was able to move quickly as human trials progressed, rather than waiting for all data to be collected at the end of the trial. Said.
“Covid-19 vaccines, including this, have been developed in a coordinated manner that allows several steps in this process to be performed in parallel to reduce the time required, but with safety, quality, and efficacy. It does not mean a sexual procedure and expected criteria. It was bypassed. ”
This month, approval is expected by both the US Food and Drug Administration and the European Medicines Agency.
Britain’s Deputy Chief Medical Officer Jonathan Vantam has also counterattacked critics, suggesting that there are sour grapes on the side of regulators who are bound by more cumbersome procedures.
“If you’re a little late regulator, what do you say to justify your position that you’re even more late? Probably the kind of words we’ve heard,” he said. I told the BBC on Wednesday.
After London defeated Brussels to approve the Pfizer / BioNTech jab, some British ministers wandered into anti-EU Jingoism.
However, Vantam also emphasized the international nature of scientific cooperation.

UK drug regulators defend the fast pace of vaccine approval

Source link UK drug regulators defend the fast pace of vaccine approval

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