Europe's drugs regulator will review AstraZeneca and Oxford University's COVID-19 vaccine this month under an accelerated timeline, after the British drugmaker submitted an application for conditional approval, the watchdog said on Tuesday.
The European Medicines Agency (EMA) said it would fast-track the assessment of the application and could issue an opinion on a conditional marketing authorisation by January 29th at a meeting of its human medicines committee (CHMP).
If endorsed by the EMA and formally approved by the European Commission, the AstraZeneca vaccine would become the third vaccine against the new coronavirus 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.
European Union 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.
The President of the European Commission, Ursula von der Leyen also welcomed the news on Twitter.
She said “Good news! @AstraZeneca has applied to @EMA_News to have its vaccine authorised in the EU. @EMA_News will assess the vaccine’s safety & efficacy. Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.”
Good news! @AstraZeneca has applied to @EMA_News to have its vaccine authorised in the EU. @EMA_News will assess the vaccine’s safety & efficacy.
Once the vaccine receives a positive scientific opinion, we will work full speed to authorise its use in Europe.— Ursula von der Leyen (@vonderleyen) January 12, 2021
