How did the UK become the first to approve the Pfizer-BioNTech vaccine and are there dangers authorizing it so quickly?



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The UK government’s Department of Health and Welfare Executive Agency validated the Pfizer-BioNTech two-dose vaccine ahead of the US and Europe.

AP

The UK Medicines and Health Products Regulatory Agency became the first regulator in the Western world to approve the COVID-19 vaccine developed by US pharmaceutical manufacturer Pfizer PFE,
+ 2.87%
and its German partner BioNTech BNTX,
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The speed with which the government’s Department of Health and Welfare executive agency validated the two-dose vaccine ahead of the US and Europe raised doubts as to how it moved so fast and whether all safety have been followed.

Dr June Raine, director of supervision and risk management at the MHRA, said in a press conference on Wednesday: “A really important point is the thorough, scientifically rigorous and methodologically sound work the agency has done.

“The way we work in continuous review ensures that our teams of doctors and scientists work in parallel to complete all work according to strict guidelines on safety, efficacy and quality.

“This vaccine was only approved because those stringent tests were performed and met, and everyone can be absolutely certain that no corner whatsoever has been cut.”

A key reason the UK was able to approve the vaccine so quickly is that previously the authorization of new drugs was overseen by the European Medicines Agency, which was based in London until March 2019. closely with the MHRA, also based in the UK, which has been delegated much of the work to authorize European medicines.

The MHRA was able to act swiftly in approving the Pfizer-BioNTech vaccine because it has an experienced team of 1,200 scientists with the best expertise examining the safety of these types of vaccines.

Although technically the EMA still has the power to authorize medicines in the UK until the end of the year, when the UK formally breaks ties with the European Union, the UK government and the MHRA can ignore it in situations. of emergency.

Raine said: “The public can be absolutely confident that every rigorous scrutiny has been done to arrive at the judgment we have reached, that the benefits far outweigh any risk, but the safety of the vaccine has been independently reviewed by our Commission. on medicines for humans, and no stone was left intact.

“I would simply like to conclude by reiterating that this vaccine manufactured and developed by Pfizer BioNTech meets rigorous high standards of safety, efficacy and quality. Public safety has always been at the forefront of our minds, safety is our watchword and will continue to be forever “.

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