UK set to approve Pfizer-BioNTech Covid vaccine within days

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The UK is poised to become the first western country to approve a Covid-19 vaccine, with the independent regulator set to grant approval within days.

Deliveries of the vaccine developed by BioNTech and Pfizer would begin within hours of the authorisation, according to government officials. The first injections could take place from December 7.

The UK has ordered 40m doses of the two-shot product, which preliminary data found to be more than 95 per cent effective in preventing disease.

Vaccines would normally be authorised by the European Medicines Agency until the end of the Brexit transition on December 31. However the UK’s Medicines and Healthcare Products Regulatory Agency has the power to temporarily authorise products, in cases of urgent public need.

The same process could be applied to the vaccine developed by AstraZeneca and Oxford university. On Friday, the government wrote to the regulator, asking it to review the AstraZeneca-Oxford vaccine.

Russia approved a coronavirus vaccine in August, but this was not based on large-scale trial data.

Downing Street announced on Saturday that Nadhim Zahawi, a junior minister at the Department for Business, would be seconded to the Department for Health as a minister to oversee the roll out of Covid-19 vaccines.

BioNTech and Pfizer earlier this month submitted data from the large-scale phase 3 trial, which involved more than 43,000 people, to the US Food and Drug Administration.

An emergency US approval could come as soon as 8-10 December, with shipments across the country starting within 24 hours of the announcement, according to US media reports.

The companies have been providing data to the EMA at the same time, as well as to authorities in the UK, Canada, Japan and Australia. Both the EMA and MHRA are conducting rolling, or accelerated, reviews of a number of vaccine candidates.

Regulators face the difficult task of balancing a significant public health need with the imperative of projecting trust in safe and effective vaccines, which will be essential in stemming the pandemic.

US president Donald Trump pushed the FDA for speedy approvals to help him secure re-election. Regulators, however, stood their ground.

The MHRA’s chief, June Rain, said: “The safety of the public will always come first. Our job is to work to the highest standards and safety is our watchword.”

Deliveries of the Pfizer-BioNTech jab, which will become the first licensed vaccine to use mRNA technology, have to be carefully co-ordinated, as it must be stored at roughly -70C during transportation, and can only be kept in a fridge for a maximum of five days before being administered.

The British government, which was the first to secure supply of the BioNTech jab in July, has said it would roll out the vaccine using a network of GPs, NHS hospitals, and dedicated sites.

Health secretary Matt Hancock told MPs this week: “If these vaccines are approved, the NHS stands ready to roll them out as soon as safely possible.”

The Joint Committee on Vaccination and Immunisation has suggested that care home residents and staff be first in line for the shots, followed by those aged over 80 and general health workers. 

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