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Pfizer-BioNTech COVID-19 vaccine gets EUA approval from the UK

Pfizer-BioNTech COVID-19 vaccine gets EUA approval from the UK

by expresspharma

December 3, 2020

The UK became the first western country to approve a COVID-19 vaccine, jumping ahead of the US and Europe after its regulator cleared a shot developed by Pfizer for emergency use in record time. The vaccine will be rolled out from early next week

“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,” the government said.

Britain touted the approval as a global win and a ray of good hope amid the gloom as big powers race to approve an array of vaccines and inoculate their citizens.

China has already given emergency approval for three experimental vaccines and has inoculated around one million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.

Pfizer and its German partner BioNTech have said their vaccine is 95 per cent effective in preventing illness.

The US drugmaker said Britain’s emergency use authorisation marks a historic moment in the fight against COVID-19.

Britain’s medicines regulator approved the vaccine in record time. Its US counterpart is set to meet on December 10 to discuss whether to recommend emergency use authorisation of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by December 29.

Britain’s vaccine committee will decide which priority groups will get the jab first: care home residents, health and care staff, the elderly and people who are clinically extremely vulnerable will be first in line.

Matt Hancock, British Health Secretary said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70oC, the sort of temperature typical of an Antarctic winter.

Pfizer has said it can be stored for up to five days at standard refrigerator temperatures, or for up to 15 days in a thermal shipping box.

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine – enough for just under a third of the population as two shots of the jab are needed per person to gain immunity.

Other frontrunners in the vaccine race include US biotech firm Moderna, which has said its shot is 94 per cent successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70 per cent effective in pivotal trials and could be up to 90 per cent effective.

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