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The UK has become the first country to approve a Covid-19 vaccine following large-scale clinical trials and is set for the BioNTech and Pfizer injection to be available from ‘next week’.
Germany’s BioNTech and US pharmaceutical giant Pfizer said doses of the vaccine would be shipped to the UK in the coming days after the UK Medicines and Healthcare Products Regulatory Agency announced approval on Wednesday morning.
The vaccine is 95 percent effective in preventing the disease, according to data released last month from the companies’ Phase 3 trial, which involved more than 43,000 people.
A UK government spokesperson said: “The vaccine will be available throughout the UK from next week. The NHS has decades of experience in implementing large-scale vaccination programs and will begin to put into action its extensive preparations to provide care and support to all those eligible for vaccination. “
Health Secretary Matt Hancock told the BBC: “Now I am sure, with today’s news, that starting in the spring, starting with Easter, things are going to get better. We’re going to have a summer next year that everyone can enjoy. ”
The inoculation, which uses a new mRNA technology, is still under review by US and EU regulators. A decision by the US Food and Drug Administration is expected in mid-December, but the Amsterdam-based European Medicines Agency has said it is unlikely to approve the jab until the end of the month.
China and Russia approved Covid-19 vaccines for early or limited use, but both countries authorized the injections without waiting for the results of the phase 3 trials, prompting criticism from some experts who cautioned that the rushed process was risky.
Britain was the first country to reach an agreement with BioNTech / Pfizer for the supply of vaccines, ordering 30 million doses in July. Since then he has signed an agreement for 10 million more doses. Approximately 10 per cent of the total UK order is expected to be delivered before the end of the year.
“We believe that the implementation of the vaccination program in the UK will reduce the number of people in the high-risk population who will be hospitalized,” said Ugur Sahin, BioNTech co-founder and CEO.
Much of the UK supply will be produced at Pfizer’s facilities in Puurs, Belgium. There will also be some production at the BioNTech sites in Germany.
Under interim plans released by the UK government last month, the vaccine, which requires two injections, roughly a month apart, will first be made available to nursing home residents and staff, before being administered to those over 80 years of age and front-line health workers.
The UK must leave the EU regulatory framework when the Brexit transition period ends on December 31. It was able to approve the vaccine earlier than the rest of Europe by using a long-standing regulatory provision that allows it to diverge from the EMA in the case of urgent public need.
The MHRA is also examining vaccine data developed by Biotech Moderna in the USA and the partnership between the University of Oxford and AstraZeneca. In all, the British government has obtained 357 million doses of seven different vaccines.