On Thursday 2 December, the European Medicines Agency (EMA) announced that it had begun a rolling review of French pharmaceutical company Valneva’s vaccine candidate, VLA2001.
This is an inactivated vaccine and therefore contains a “killed” form of SARS-CoV-2 and two adjuvants that enhance the immune response to the vaccine.
“When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it. If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend against it”, the EMA says. This technology is used for flu and polio vaccines, among others.
The launch of the VLA2001 evaluation at European level was expected: Valneva had already mentioned this in early November, after signing a contract with the European Commission to supply 60 million doses of VLA2001 to the EU (see EUROPE 12830/26).
In the meantime, Valneva has submitted laboratory studies to the EMA suggesting that its vaccine does trigger the production of antibodies targeting SARS-CoV-2.
“The rolling review will continue until enough evidence is available for a formal marketing authorisation application”, says the EMA.
As a result, the Agency is now conducting a rolling review of four candidate vaccines and is considering an application for a fifth vaccine, which may be completed shortly (see EUROPE 12834/20).
More details: https://bit.ly/3G6Wnkq (Original version in French by Agathe Cherki)