The UK has become the first country in the world to approve the coronavirus vaccine developed by Oxford University and AstraZeneca as it battles a major winter surge driven by a new, highly contagious variant of the virus.
AstraZeneca said the authorisation was for a two-dose regime and that the vaccine had been approved on Wednesday for use for emergency supply.
The approval was a “triumph for British science”, Prime Minister Boris Johnson said.
“It is truly fantastic news – and a triumph for British science – that the @UniofOxford/@AstraZeneca vaccine has been approved for use,” Johnson tweeted.
Britain has ordered 100 million doses of the vaccine.
The AstraZeneca/Oxford shot, unlikely to be approved for some time by EU or US regulators, will start being administered on Monday, beginning with those most at risk from COVID-19.
“The government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s COVID-19 vaccine for use,” the health ministry said.
Britain is already rolling out the Pfizer-BioNTech vaccine.
In a change of approach, the Joint Committee on Vaccination and Immunisation (JCVI) said the priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.
Health minister Matt Hancock said the MHRA would set out more details on the dosing regimen later on Wednesday.
The regulatory endorsement is a welcome boost for AstraZeneca and the Oxford team, which have been accused of a lack of clarity about the results from late-stage trials.
“Today is an important day for millions of people in the UK who will get access to this new vaccine,” AstraZeneca Chief Executive Pascal Soriot said. “It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit”
Pooled results from those trials show it had an overall efficacy of 70.4 percent. Efficacy was 62 percent for trial participants given two full doses, but 90 percent for a smaller sub-group given a half dose followed by a full dose.
Researchers said that the finding of 90-percent efficacy for the low-dose/high-dose regime needed more investigation. AstraZeneca did not specify which dose regime had been approved.
“To get out of this debacle there is no alternative to having a significant majority of the population carrying a high level of neutralising antibodies. With today’s announcement that comes within our grasp,” said Danny Altmann, a professor of immunology at Imperial College London.
“I suspect this will speed things by several months. An immune population by the spring starts to look feasible.”
The pandemic has already killed 1.7 million people around the world, sown chaos through the global economy and upended normal life for billions since it began in Wuhan, China, a year ago.
Britain and South Africa, in particular, are grappling with new variants of the coronavirus, which governments and scientists say are more contagious. Many countries have responded by banning passenger flights and blocking trade.
AstraZeneca and other developers have said they are studying the impact of the new variant but expect that their shots will be effective against it.
“It’s a huge step forward and it could not have come at a better time because the situation in the UK has been worsening significantly in the last few days,” Al Jazeera’s Rory Challands said from London.
“For two running days, we had a record number of new infections. Over 53,000 new cases yesterday, and more than 40,000 new cases the day before. So things are getting significantly worse here.
“This injection is much easier to use, to transport and administer than the Pfizer/BioNTech which is the one that has been used until now … so it can vaccinate more people and more quickly.”