Home LIFESTYLE Corona Virus The UK Drug Regulator defends the quick rate of approval of vaccines

The UK Drug Regulator defends the quick rate of approval of vaccines

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The UK Drug Regulator defends the quick rate of approval of vaccines
The UK Drug Regulator defends the quick rate of approval of vaccines

On Friday, the UK Medicines Regulator insisted its world-first approval of the Pfizer-BioNTech coronavirus vaccine met all safety requirements after officials raised questions about the rapid process in Europe and the United States.

On Wednesday, Britain announced it had issued emergency approval for the general use of the vaccine and would start rolling it out next week.

The MHRA regulator said in a statement, “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 approved for delivery in the United Kingdom unless the expected protection, quality, and efficacy requirements were met, “No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met,”

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On Thursday, leading US infectious disease scientist Anthony Fauci said that the MHRA had “rushed through that approval” but apologised later.

Fauci, who heads the US National Institute of Allergy and Infectious Diseases, told the BBC, “I have a great deal of confidence in what the UK does both scientifically and from a regulator standpoint,”

“Our process is one that takes more time than it takes in the UK. And that’s just the reality,” he said, adding: “I did not mean to imply any sloppiness even though it came out that way.”

Beginning next week, Britain aims to deliver an initial batch of 800,000 doses, giving priority to care homes.

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In vetting the Pfizer-BioNTech vaccine, MHRA Chief Executive June Raine previously insisted that no corners had been cut”.

With Britain leaving the European Union, the UK regulator has obtained an exception from the EU Medicines Agency, which has emphasised that it wants to wait for further bloc-wide analysis and consultation.

After launching a rolling analysis of data generated by Pfizer and BioNTech as human trials progressed, the MHRA said it was able to move rapidly instead of waiting for all the data to be collected at the end of the trials.

COVID-19 vaccines, including this one, are being developed in a coordinated way that allows some stages of this process to take place in parallel to condense the time necessary, but it does not imply that measures have been taken and the expected protection, quality, and efficacy standards have been circumvented, “COVID-19 vaccines, including this one, are being developed in a coordinated 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,”

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

Jonathan Van-Tam, England’s deputy chief medical officer, has also hit critics back, signalling sour grapes on the part of regulators bound by more cumbersome procedures.