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The British government said on Friday that it asked its independent drug regulator to evaluate AstraZeneca’s coronavirus vaccine as part of the formal approval process for the drug to be launched before the end of the year.
More than 1.4 million people have died since the novel coronavirus emerged in China late last year, and three drug developers, Pfizer / BioNTech, Moderna and AstraZeneca / Oxford University, are currently applying for approval for their vaccines are used from December.
AstraZeneca has completed phase III clinical trials of its vaccine, the last stage before regulatory approval.
But under British rules, the government must also ask the Medicines and Healthcare Products Regulatory Agency (MHRA) to give the drug the green light.
“We have formally asked the regulator to evaluate the Oxford / AstraZeneca vaccine, understand the data and determine if it meets rigorous safety standards,” said Health Secretary Matt Hancock.
Britain has secured access to 100 million doses of the vaccine produced by the British drug manufacturer in partnership with the University of Oxford.
The health department has said it expects four million doses of the injection to be ready for Britain by the end of the year and 40 million by the end of March 2021.
Earlier Thursday, AstraZeneca said more research is needed on the vaccine, but that further testing is unlikely to affect the approval process.
The AstraZeneca vaccine has shown an average effectiveness of 70 percent.
But that rate jumped to 90 percent when an initial half dose and then a full dose were administered, similar to rival vaccines in development by Pfizer / BioNTech and Moderna.
American scientists have said that the highest rate of effectiveness occurred during testing in people 55 and younger, and was discovered by accident during clinical trials.
“Now that we’ve found what looks like better efficacy, we have to validate this, so we need to do an additional study,” AstraZeneca CEO Pascal Soriot told Bloomberg.
The UK government has already formally asked the MHRA to assess the suitability of the Pfizer / BioNTech vaccine.
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