The UK has become the first country to approve a Covid-19 vaccine following large-scale clinical trials and is set to make the shot from BioNTech and Pfizer available from “next week”.
Germany’s BioNTech and US pharma giant Pfizer said doses of the vaccine would be delivered to the UK in the coming days after the UK’s Medicines and Healthcare products Regulatory Agency announced the approval on Wednesday morning.
The vaccine is 95 per cent 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 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.”
Matt Hancock, health secretary, told the BBC: “I’m confident now, with the news today, that from spring — from Easter onwards — things are going to be better. We’re going to have a summer next year that everybody can enjoy.”
The inoculation, which uses novel mRNA technology, is still under review by US and EU regulators. A decision from 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 have approved Covid-19 vaccines for early or limited use but both countries authorised the shots without waiting for the results of phase-3 trials, provoking 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 30m doses in July. It has since signed a deal for a further 10m doses. Roughly 10 per cent of the UK’s total order is expected to be delivered before the end of the year.
“We believe that the rollout of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised,” said Ugur Sahin, co-founder and chief executive of BioNTech.
Much of the UK’s supply will be produced at Pfizer’s facilities in Puurs, Belgium. There will also be some production at BioNTech’s sites in Germany.
Under provisional plans released by the UK government last month, the vaccine — which requires two shots, roughly a month apart — will first be made available to care home residents and staff, before being administered to those aged over 80 and to frontline health workers.
The UK is due to leave the EU’s 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 longstanding regulatory provision that allows it to diverge from the EMA in the case of urgent public need.
The MHRA is also examining data on vaccines developed by the US biotech Moderna and the partnership between Oxford university and AstraZeneca. In total, the British government has secured 357m doses of seven separate vaccines.