The British government has formally asked the UK’s independent medicines regulator to assess the suitability of Oxford/AstraZeneca’s COVID-19 vaccine for temporary supply, a statement said Friday.
The request is considered the first step toward getting the vaccine approved for deployment, “should it meet the regulator’s requirements,” read the statement from the Department of Health and Social Care.
“The UK will be the first country to sign an agreement with Oxford University/AstraZeneca to receive 100 million doses of the vaccine, which officials have announced provides 90% protection against COVID-19 when one and a half dose is applied,” Matt Hancock, UK health secretary, 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,” he added.
The Medicines and Healthcare products Regulatory Agency (MHRA) has been asked to “assess the vaccine for authorization under Regulation 174 of the Human Medicines Regulations, which enables the temporary supply of medicines to be authorized in response to a public health need.”
The MHRA has already started a rolling review to determine whether the Oxford/AstraZeneca vaccine meets its strict standards of safety, efficacy, and quality, according to the statement.
“Until the end of December, and as part of the [Brexit] transition period, vaccines must be authorized via the European Medicines Agency and that authorization will automatically be valid in the UK,” said the statement.
“However, if a suitable COVID-19 vaccine candidate, with strong supporting evidence of safety, quality and effectiveness from clinical trials becomes available before the end of the transition period, EU legislation which we have implemented – Regulation 174 – allows the MHRA to temporarily authorize the supply of a medicine or vaccine, based on public health need,” it added.
The move comes as England is preparing to end a four-week national lockdown and transit into a three-tier system, which will keep most of the population under strict measures.
With over 57,000 fatalities, the UK has the highest coronavirus death toll in Europe, according to official data.