(Sharecast News) – The EU’s drugs regulator said it would review a conditional approval application for AstraZeneca and Oxford University’s Covid-19 vaccine this month under an accelerated timeline.
The European Medicines Agency (EMA) on Tuesday said it would fast-track an assessment and could issue an opinion on a conditional marketing authorisation by January 29 at a meeting of its human medicines committee (CHMP).
“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 in a statement.
If endorsed by the EMA and formally approved by the European Commission, the vaccine would become the third against the new virus available on the continent after Pfizer’s and Moderna’s.
The EMA also said that during its rolling review of the vaccine, it had assessed data from ongoing trials in Brazil, Britain and South Africa. It is also studying additional information provided by AstraZeneca at the CHMP’s request.
EU conditional marketing authorisation allows a treatment to be sold for a year in the 27-nation bloc before all necessary data on its efficacy and side-effects are available.
AstraZeneca’s vaccine has been approved in countries including Argentina, Britain, El Salvador and India. Brazil is expected to decide on approval this week.
“If EMA concludes that the benefits of the vaccine outweigh its risks in protecting against Covid-19, it will recommend granting a conditional marketing authorisation. The European Commission will then fast-track its decision-making process with a view to granting a conditional marketing authorisation valid in all EU and EEA Member States within days,” the agency said.
