Regulatory approval could come as soon as 29 January
The European Medicines Agency has received an application for evaluation of the Covid-19 vaccine developed by the company AstraZeneca and the University of Oxford, which is expected to lead to the EU approving its third vaccine against the disease.
The regulator said its assessment would “proceed under an accelerated timeline”, with a decision possible when its scientific committee for human medicines meets on 29 January.
“Such a short timeframe for evaluation is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the EMA said on 12 January, adding that it would approve the vaccine only if data on its safety and efficacy is “sufficiently robust”.
The EMA has approved two Covid-19 vaccines so far: first the one developed by the companies Pfizer and BioNTech and then one developed by the company Moderna. The EU’s go-ahead for both lagged behind that of the United States, leading to some criticism of its pace.
The EMA requested additional information from AstraZeneca after its vaccine had already been approved in the UK. European Commission president Ursula Von der Leyen said the Commission would work at “full speed” to authorise AstraZeneca’s vaccine as soon as it passes regulatory approval.