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COVID-19: UK approves Pfizer/BioNTech vaccine, orders for 40m doses

...Vaccination begins next week with 800,000 doses


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THE United Kingdom becomes the first country in the world to administer the COVID-19 vaccine on its population, as it granted temporary authorization for emergency use of Pfizer/BioNTech’s vaccine (BNT162b2), Wednesday.

Comprising England, Scotland, Wales and Northern Ireland, the UK currently has 1.64 million confirmed cases of the virus and 59,051 deaths.

The UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) approved the use of the vaccine and consequently made an order for delivery of 40 million doses between this December and 2021.

Vaccination kicks off next week, the Department said at a media briefing.

UK’s approval of the Pfizer/BioNTech vaccine makes the product to beat other vaccine candidates, worldwide.

Nigeria’s Dr. Onyema Ogbuagu’s effort to the development of the vaccine was greatly commended by the US last week.

The elderly in care homes, front line health workers and vulnerable people will be prioritized in the first set of vaccination, kicking off next week.

40 million vaccines will be administered to 20 million people in the UK, as each person is expected to be given two doses.

UK Health Secretary, Matt Hancock told the BBC that an initial 800,000 doses would be available in the UK next week, and would deployed at the speed that it’s manufactured by Pfizer at its facilities in Belgium.

With the vaccine, “help is on the way” for lives and economy to have a fresh start, Hancock stated.

“It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again,” Prime Minister, Boris Johnson said in response to the breakthrough, in a tweet.

In a joint press statement, US pharma giant, Pfizer and its German firm partner, BioNTech said they “are ready to deliver first doses to the UK immediately.”

The statement said “first authorization for a COVID-19 vaccine represents a scientific achievement to help combat this devastating pandemic.

“This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals.”

Wednesday’s authorization in the U.K. marked a historic moment in the fight against COVID-19, noted the statement.

Chairman and Chief Executive Officer, Pfizer, Albert Bourla, was quoted as applauding the MHRA for its ability to conduct a careful assessment and take timely action to help protect the people of the U.K.

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” he added.

Similarly, CEO and co-founder of BioNTech., Ugur Sahin, said in the statement that “the Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19.

He expressed hope that the roll-out of the vaccination programme in the U.K. would reduce the number of people in the high-risk population being hospitalized.

He said the aim of the firms producing the vaccine was to bring a safe and effective vaccine upon approval to the people who need it.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program,” he added.

The MHRA’s data from phase 3 of clinical study of the vaccine have shown efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective).

Pfizer and BioNTech said efficacy of the product was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%.

“In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2,” the firms said.

Pfizer said it had a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need.

“Pfizer and BioNTech are confident in their ability to safely and effectively deliver the vaccine to the people in the U.K. Based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization).”

In a statement, the Department of Health said “the government has today accepted the recommendation from the Independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use. This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

“The Joint Committee on Vaccinations and Immunisations (JCVI) will shortly publish its final advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

“The vaccine will be made available across the UK from next week. The NHS has decades of experience in delivering large-scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination.”

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