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UK could approve Pfizer’s COVID-19 vaccine this week

The Telegraph reported the possible timeframe on Sunday

The UK government could approve Pfizer and BioNTech’s COVID-19 vaccine candidate this week, according to a report from The Telegraph.

The report, which cited government sources, said that British medicines regulators were launching a formal review of the vaccine and added that the NHS has been told to prep itself to start delivering the vaccine by 1 December.

In a statement released today, the UK government ‘welcomed’ the Medicines and Healthcare products Regulatory Agency’s (MHRA) review of Pfizer/BioNTech’s COVID-19 vaccine BNT162b2.

“The whole country will be cheered by the news that Pfizer/BioNTech have formally reported the data from their clinical trials for their vaccine to the regulator. This is another important step on the road to recovery,” said Health Secretary Matt Hancock.

“If approval is granted, the NHS 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 added.

The UK government previously signed a deal with Pfizer/BioNTech for 40 million doses of BNT162b2, with the majority of the doses expected in the first half of 2021.

In addition, the government does not anticipate any issues to arise from the required cold supply chain needed for the safe delivery and storage of BNT162b2.

The vaccine candidate needs to be both distributed and stored at -70˚C (minus 94°F), which is well below the typical vaccine storage temperature of +2˚C to +8˚C.

Pfizer initiated a pilot delivery programme for BNT162b2 in the US last week, amid concerns over potential distribution issues relating to the vaccine.

The pilot programme is being conducted in four states in the US and will aim to improve understanding for accurate planning, deployment and administration of BNT162b2.

For inclusion in the pilot, Pfizer selected Rhode Island, Texas, New Mexico and Tennessee based on the differences in each states’ overall size, diversity of populations and immunisation infrastructures, as well as the states’ need to reach individuals in varied urban and rural settings.

The US Food and Drug Administration (FDA) is set to convene an expert panel to discuss and review the data for BNT162b2 on 10 December.

The FDA’s announcement closely followed Pfizer/BioNTech’s emergency use authorisation (EUA) submission for the COVID-19 vaccine on Friday.

Article by
Lucy Parsons

23rd November 2020

From: Regulatory



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