The UK has become the first country to approve a Covid-19 vaccine after large-scale clinical trials and will make the shot from BioNTech and Pfizer available for the first round of inoculations next week.
Germany’s BioNTech and US pharmaceutical company 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 BioNTech/Pfizer shot 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.
“This is unquestionably good news, but it is not the end of the story,” Boris Johnson, UK prime minister, told members of parliament. He has said the shot will be made available across the country from “next week”, but cautioned that vaccinations would take time.
Simon Stevens, chief executive of NHS England, said the “bulk” of vaccinations for at-risk individuals would take place between January and April next year.
The approved vaccine, 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.
The MHRA approved the BioNTech/Pfizer shot following “an extremely thorough and scientifically rigorous review of all the evidence”, said June Raine, the agency’s chief executive. “The public can be absolutely confident that the standards we have worked to are equivalent to those around the world.”
Members of the UK government celebrated the announcement as a national victory. “In years to come, we will remember this moment as the day the UK led humanity’s charge against this disease,” Alok Sharma, business secretary, tweeted.
But some European officials criticised the “national” language. “Why is it so difficult to recognise this important step forward as a great international effort and success,” said Andreas Michaelis, Germany’s ambassador to the UK, in response to Mr Sharma.
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. About 800,000 doses should be available in the UK next week, with 10 per cent of the total order 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.
Under provisional plans released by the UK government last month, the vaccine — which requires two shots, at least 21 days apart — will first be made available to care-home residents and staff, people aged over 80 and to frontline health workers.
Fifty hospitals will initially offer the vaccine to NHS staff from next week, before distribution is expanded to 1,000 doctors’ surgeries across the country, the government said on Wednesday. Delivery in care homes may have to be added later, possibly with other vaccines once they are approved by the MHRA, it said.
Distribution of the BioNTech/Pfizer vaccine would be “logistically complicated”, cautioned Sir Simon at NHS England, as it has to be transported at -70C.
Wei Shen Lim, chair of the UK’s Joint Committee on Vaccination and Immunisation, said that after the highest priority groups are vaccinated, the first phase would be extended to younger age brackets eventually including all those over 50, and those aged between 16 and 64 with underlying health conditions. “We hope 90-99 per cent of people at risk of dying from Covid-19 will be included or covered.”
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 regulatory provision that also exists under EU law and allows member states to diverge from the EMA in the case of urgent public need.
“We’ve been able to authorise supply of this vaccine under provisions under European law which exist until January 1,” said Dr Raine of the MHRA.
Jacob Rees-Mogg, leader of the House of Commons, sought to link the rapid approval to Brexit. “We could only approve this vaccine so quickly because we have left the EU,” he said.
The MHRA is also examining data on vaccines developed by the US biotech Moderna and the partnership between the University of Oxford and AstraZeneca. In total, the British government has secured 357m doses of seven separate vaccines.
But Jonathan Van-Tam, the UK’s deputy chief medical officer, warned that a vaccine would not rid the world of Covid-19 entirely. “I don’t think we’re going to eradicate coronavirus forever, it’s going to be with humankind forever,” he said.
