The government has “formally” asked regulators to assess whether the coronavirus vaccine created by Oxford University and pharmaceutical giant AstraZeneca can be authorised.
The move marks a significant step towards getting the vaccine – which the UK has secured 100m doses of – rolled out, the Department of Health and Social Care said.
However, the Medicines and Healthcare products Regulatory Agency (MHRA) must first evaluate safety, quality and efficacy data for the jab, which needs to be supplied by the company.
The agency had already started a rolling review of the Oxford jab to see if it met its standards, according to the government.
But England’s deputy chief medical officer Jonathan Van-Tam has now written to the MHRA asking for a more in-depth assessment of the vaccine to see if it could be authorised for temporary supply.
Health secretary Matt Hancock called the letter an “important step towards deploying a vaccine as quickly as safely possible”.
“We are working tirelessly to be in the best possible position to deploy a vaccine as soon as one is approved by the independent regulator the MHRA,” he said.
“We have formally asked the regulator to assess the Oxford/AstraZeneca vaccine, to understand the data and determine whether it meets rigorous safety standards.”
Hancock said last week that the NHS could start vaccinating people against coronavirus in December if a vaccine was approved by regulators.
If approved, the UK is in line to receive 4m doses of the Oxford/AstraZeneca vaccine by the end of the year and 40m by the end of March.
Data published by Oxford University and AstraZeneca on Monday suggested the jab has an average efficacy rate of 70% – but that this figure rose to 90% when trial participants were accidentally given half a dose of the vaccine, followed by a full dose.
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On Thursday night, researchers announced they planned to conduct an additional global trial to assess the vaccine to validate this.
AstraZeneca CEO Pascal Soriot told Bloomberg News: “Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study.”
Soriot said he did not expect the additional trial to hold up regulatory approvals in the UK and European Union – but it is thought the concerns over the trial could hold up approval in the US.
Asked about this at a press conference on Thursday, chief medical officer for England Chris Whitty said there was always debate “about virtually everything”.
“The key thing to do is leave this in the hands of the regulator,” he added.
The Oxford vaccine is not the first vaccine the government has formally asked the MHRA to assess – it has also asked the agency to evaluate the Pfizer/Biotech jab.
According to phase III trial data, the Pfizer vaccine has an efficacy rate of 95% for people over the age of 65, who are at an elevated risk from Covid-19. The UK has procured 40m doses of this jab.