Britain on Wednesday became the first country in the world to approve a 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.
Boris Johnson’s government, which has already ordered 100 million doses of the vaccine, has jumped ahead of other Western countries with its vaccination program.
It was the first to approve a shot developed by Pfizer of the United States and Germany’s BioNTech, with the result that hundreds of thousands of people were vaccinated in Britain before European Union countries and the United States even began administering it this month.
The AstraZeneca/Oxford shot, unlikely to be approved for some time by EU or U.S. regulators, will start being administered on Monday, beginning with those most at risk from COVID-19.
While the approval by the UK Medicines and Healthcare products Regulatory Agency (MHRA) is a vindication for a shot seen as essential for mass immunisations in the developing world as well as in Britain, it does not eliminate questions about trial data that make it unlikely to be approved so rapidly in the European Union or the United States.
Uncertainty has swirled over the most effective dosing pattern for the AstraZeneca/Oxford vaccine since it released data last month showing a 90% success rate for a half-dose followed by a full dose, but only 62% – still usually more than enough for regulators – for two full doses.
The MHRA said that the results for the half-dose regimen had not been borne out by analysis. Instead, it approved the regimen of two full doses.
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An official involved in the MHRA decision, said that the vaccine’s effectiveness had risen when the doses were given three months apart.
“Effectiveness was high, up to 80%, when there was a three- month interval between first and second doses, which is the reason for our recommendation,” Munir Pirmohamed, Chair of the Commission on Human medicines expert Working Group on COVID-19 vaccines, told reporters.
Hancock said hundreds of thousands of doses would be available to administer next week in Britain.
“The NHS (National Health Service) will be able to deliver these shots into people’s arms at the speed at which it can be manufactured,” Health Secretary Matt Hancock told Sky News.
“I am also now, with this approval this morning, highly confident that we can get enough vulnerable people vaccinated by the spring that we can now see our route out of this pandemic.”
Crucially for countries with relatively basic health infrastructure, the AstraZeneca/Oxford vaccine can be stored and transported under normal refrigeration, rather than supercooled to -70 degrees Celsius (-94 Fahrenheit).
The vaccine is one of two candidates currently undergoing a rolling review by Health Canada, along with one developed by Johnson & Johnson. The agency has not said when approval might come for the AstraZeneca shot.
India is keen to start administering the new shot next month; Serum Institute of India (SII), the world’s biggest producer of vaccines, has already made about 50 million doses. Chile is also interested.
(Reporting by Alistair Smout and Paul Sandle in London, additional reporting by Pushkala Aripaka in Bengaluru, Kate Kelland in London, John Miller in Zurich, Emilio Parodi in Milan; editing by Guy Faulconbridge and Kevin Liffey)
–With files from Global News and the Associated Press
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