The British government said on Friday ithas asked its independent medicines regulator to assess AstraZeneca’scoronavirus vaccine as part of the formal approval process for the drug to berolled out by the end of the year, reports AFP.
More than 1.4 million people have died since the novel coronavirus emergedin China late last year, and three drug developers — PfizerBioNTech,Moderna and AstraZenecaOxford University — are currently applying forapproval for their vaccines to be used as early as December.
AstraZeneca has completed Phase III clinical trials of its vaccine, thelast stage before regulatory approval.
But under British rules, the government must also ask the independentMedicines and Healthcare products Regulatory Agency (MHRA) to green light thedrug.
“We have formally asked the regulator to assess the OxfordAstraZenecavaccine, to understand the data and determine whether it meets rigorous safety standards,” said Health Secretary Matt Hancock.
Britain has secured access to 100 million doses of the vaccine produced bythe British drug manufacturer in partnership with the University of Oxford.
The department of health has said it expects four million doses of the shotto be ready for Britain by the end of the year and 40 million by the end of March 2021.
Earlier on Thursday, AstraZeneca said further research was needed on thevaccine, but the additional testing was unlikely to affect the approval process.
The AstraZeneca vaccine has shown an average 70-percent effectiveness.
But that rate jumped to 90 percent when an initial half-dose then a full dose was given, similar to that in rival vaccines in development byPfizerBioNTech and Moderna.
US scientists have said the higher rate of effectiveness came during testsin people aged 55 and under, and was discovered by accident during theclinical trials.
“Now that we’ve found what looks like a better efficacy, we have tovalidate this, so we need to do an additional study,” AstraZeneca chiefexecutive Pascal Soriot told Bloomberg.
The UK government has already formally asked the MHRA to assess thePfizerBioNTech vaccine for its suitability.