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Pfizer-BioNtech Covid19 Vaccine Being Reviewed By UK Medical Regulator

Pfizer-BioNtech Covid19 Vaccine Being Reviewed By UK Medical Regulator
Data from Pfizer/BioNTech about its recently concluded clinical trials for its Covid-19 vaccine us being reviewed by the Medicines and Healthcare products Regulatory Agency’s (MHRA) of the United Kingdom, the government said, which will be used for determining whether the vaccine candidate is able to satisfy the "robust" standards of quality, safety, and effectiveness.   
The two companies behind the development of the vaccine, American pharmaceutical giant Pfizer and German biotech firm BioNTech, have already claimed that their vaccine is 94 per cent effective in preventing the disease among people who are over 56 years of age and have also claimed that the results of the trial have indicated that the vaccine is also equally effective in people of all ages, races and ethnicities.
“Today, we have renewed hope that we are on the brink of one of the most significant scientific discoveries of our time, as we reach the crucial last stage to finding a Covid-19 vaccine,” said UK Business Secretary Alok Sharma.
“While this news is a cause for celebration, we must make sure that this vaccine, like all new medicines, meets standards of quality, safety, and effectiveness. I urge the public to be patient while we wait for regulators to do a thorough assessment. Finding a vaccine is not going to end the pandemic overnight, but we are hopeful of being one step closer to defeating this terrible virus,” the minister of Indian-origin said.
By the end of 2021, it is expected that a total of 40 million vaccine doses wil be available in the UK which will be enough to vaccinate about one third of the total population of the country and the government expects to receive the majority of the doses in the first half of next year.
“This is another important step on the road to recovery. We must now allow the MHRA’s renowned teams of scientists and clinicians to make an independent assessment of whether it meets their robust standards of quality, safety, and effectiveness,” said UK Health Secretary Matt Hancock.
“If approval is granted, the NHS [National Health Service] will be ready to deliver. The NHS has vast experience in delivering widespread vaccination programmes and an enormous amount of work has taken place to ensure we have the logistical expertise, transport and workforce to roll out a vaccine according to clinical priority, at the speed at which it can be manufactured,” he said.
Meeting of the strict standards of quality, safety, and effectiveness and the assurance that the vaccines can be consistently manufactured will be the two major considerations that will be evaluated while authorising a Covid-19 vaccine for supply by the UK’s independent regulator, the UK government has reiterated.
The NHS is preparing to keep itself ready to be able to distribute and administer the vaccine as soon as the first vaccine is approved and delivered to the UK even though the final deployment plans will depend on decisions by regulators.

Christopher J. Mitchell

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