The UK drugs watchdog on Wednesday approved the coronavirus vaccine made by Oxford university and AstraZeneca, boosting hopes that millions more Britons can be inoculated against the disease in the coming months as a new viral variant of Covid-19 takes hold.
AstraZeneca said the UK Medicines and Healthcare products Regulatory Agency had given the jab an emergency authorisation, making it the first country to approve the vaccine.
This will allow it to be rushed to patients, offering renewed optimism of taming the pandemic as the number of patients with Covid-19 in English hospitals reached an all-time high.
The UK approval attracted worldwide attention since ease of storage and at-cost pricing during the pandemic have made the Oxford/AstraZeneca vaccine an attractive option far beyond Britain. AstraZeneca has pledged to sell the vaccine at cost to developing nations in perpetuity, a condition insisted upon by Oxford university. Supply deals indicate a single dose will be priced at about $3 to $4.
The vaccine is also expected to get nods from US and EU regulators. They have respectively placed orders for 300m and 400m doses.
$3-$4
The expected price of a single Oxford/AstraZeneca vaccine dose, which the group has pledged to sell at cost
However, the European Medicines Agency will not assess the vaccine until at least next month, as it has not yet received an application from the drugmaker.
US regulators are waiting for a late-stage trial to end before assessing the vaccine.
Health secretary Matt Hancock said the vaccine roll out would begin in the UK on January 4, with preparations made for its delivery in the coming days.
“We’ve got enough of this vaccine on order to vaccinate the whole population,” he told the BBC, adding the 100m doses the UK has purchased would cover the entire adult population. “By the spring, enough people will be protected to allow us to exit the pandemic,” he said.
AstraZeneca said it was confident the vaccine would work against the new variant of Covid-19.
The vaccine’s approval is expected to boost significantly the UK’s mass vaccination programme. It is easier to store than the BioNTech/Pfizer vaccine, which has been at the centre of the campaign but must be kept at minus 70C, which UK officials say makes it difficult for some care homes and GP practices to administer.
The Oxford/AstraZeneca vaccine can be kept at between 2C and 8C — the temperature of a conventional fridge — making it easier to distribute.
The vaccine’s dosage will also speed up the programme. The MHRA has approved a dosing regimen of two doses at an interval of between four and 12 weeks that in trials proved successful in preventing severe disease.
This will allow far more Britons to be vaccinated quickly, with the long period between jabs allowing manufacturers to replenish supplies between doses.
June Raine, chief executive of MHRA, said the approval had involved “a thoroughly robust process on safety, on quality and on effectiveness”.
“The public . . . can be absolutely confident that the scientific rigour of our assessment has been as we would normally do it according to guidelines and standards,” she told a Downing Street press conference.
The developers said the vaccine had demonstrated efficacy of about 70 per cent, and there was hope that figure might rise to 80 per cent as more data was gathered.
AstraZeneca made clear that supplies of its vaccine would not be available for private purchase. The company said that all its agreements were made with governments and non-governmental organisations and supplies would be going directly to them.
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