The European Medicines Agency (EMA) can provide “conditional marketing approval (…) as early as the second half of December, if all goes smoothly,” the EC president said.
The US pharmaceutical giant Pfizer and the German company BioNTech have jointly developed a vaccine that has been successful in clinical trials and have submitted the relevant data to the EMA.
US biotechnology company Moderna has said its experimental vaccine is 95% effective.
The Amsterdam-based EMA will have to examine the test results before recommending EU approval, but von der Leiena was cautiously optimistic.
The EU has signed agreements to reserve hundreds of millions of doses of the vaccines with its vaccine developers, BioNTech, Purevac, AstraZeneca and Sanofi, should these vaccines go on the market.
“And we are continuing negotiations with Moderna and participating in negotiations with Novavax,” said von der Leiena, adding that the leaders of all 27 EU member states have expressed support for the EU’s vaccine purchasing program.
She stressed that in the case of US companies, EMA maintains daily contacts with the US Food and Drug Administration (FDA).