Covid-19: EU regulator gives conditional approval to Pfizer/BioNTech vaccine

A dose of the Pfizer/BioNtech Covid-19 vaccine

The European Medicines Agency (EMA) has granted “a conditional marketing authorisation” for the Pfizer/BioNTech vaccine.

An expert committee has recommended conditional approval for the vaccine to be used across the European Union, the agency said.

The move comes weeks after the shot was first granted permission under emergency provisions in Britain and the United States.

The decision comes after a closed-door discussion during which EMA scientists responsible for assessing the vaccine presented their analysis to other experts and scrutinised data from companies.

The approval needs to be rubber-stamped by the European Commission and the pharmaceutical companies will need to submit follow-up data on their vaccine for the next year.

Authorities in Germany and several other European countries have said they hope to begin vaccinating people on December 27.

The EMA said in a statement that the human medicines committee (CHMP) "has completed its rigorous evaluation" of the vaccine, "concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation".

Emer Cooke, Executive Director of EMA said that the "positive" news was an important step in the fight against the virus. 

We have achieved this milestone thanks to the dedication of scientists, doctors, developers and trial volunteers as well as many experts from all EU Member States.

“Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards. 

"However, our work does not stop here. We will continue to collect and analyse data on the safety and effectiveness of this vaccine to protect people taking the vaccine in the EU.”

Conditional marketing authorisation

The EMA said that conditional marketing authorisation is "a formal authorisation of the vaccine, covering all batches produced for the EU and providing a robust assessment to underpin vaccination campaigns".

It is one of EU’s regulatory mechanisms "for facilitating early access to medicines that fulfil an unmet medical need", such as the Covid-19 pandemic.

A statement revealed that because it has only been granted conditional marketing authorisation, Pfizer/BioNTech "will continue to provide results from the main trial, which is ongoing for two years. 

"This trial and additional studies will provide information on how long protection lasts, how well the vaccine prevents severe Covid-19, how well it protects immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.