The EMA's human medicines committee (CHMP) met today to consider Pfizer/BioNTech's application for conditional marketing authorisation (CMA), issuing a positive opinion this afternoon.
The European Commission will now fast-track its decision to authorize the vaccine in the EU: a process expected to happen 'imminently' (writing on Twitter, European Commission president Ursula von der Leyen predicts a decision by this evening).
This decision will be immediately applicable to all 27 Member States. The EU has already announced that vaccination will start on Sunday (December 27).
Ugur Sahin, M.D. CEO and co-founder of Germany's BioNTec - which paired up with US giant Pfizer to develop the vaccine - said: “Today is a particularly personal and emotional day for us at BioNTech. Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic.
"We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light.”
CHMP: 'Critical need' for vaccine offering high level of protection
The vaccine - called Comirnaty - has been recommended for authorization for people aged 16+. In its recommendation for authorization, the CHMP noted the large scale Phase 3 studies (around 44,000 people) for the vaccine which showed efficacy of 95%.
"Comirnaty offers a high level of protection against COVID-19 which is a critical need in the current pandemic," it says. "The Agency therefore decided that Comirnaty's benefits are greater than its risks and that it can be recommended for authorization in the EU."
A conditional marketing authorization will mean that Pfizer and BioNTech will need to continue to provide evidence about the vaccine which will be reviewed as and when it is provided. This will include information on how long protection lasts; how well the vaccine prevents against severe COVID-19; how well it protects immunocompromized people, children and pregnant women; and whether it prevents asymptomatic cases.
EU authorities will also co-ordinate independent studies on the vaccine's long-term safety and benefit in the general population.
On Friday the vaccine was also authorized by Switzerland's SwissMedic: adding to global regulatory authorizations in more than 15 countries which include the US, UK and Canada.
Meanwhile, the EMA has brought forward the CHMP meeting to assess Moderna's vaccine candidate to January 6: a week earlier than the previously scheduled date of January 12.