The European Commission is introducing a new measure that will speed up the authorisation of COVID-19 vaccines that have been adapted to protect against variants of the virus.
As part of the European bio-defence preparedness plan against COVID-19 variants, the new measure makes provisions in the relevant EU legislation to allow companies to focus on gathering the necessary evidence in time and to enable the authorisation of adapted vaccines with a smaller set of additional data submitted to the European Medicines Agency.
Adaptations to vaccines
Building on the approach for adaptations of flu vaccines, the changes to the Variation Regulation specify which provisions apply to adaptations of the active substance of authorised COVID-19 vaccines, and will ensure the streamlined handling of any variation to an authorised vaccine and extend the coverage of the new provisions to all coronaviruses.
The European Commission’s HERA Incubator is also working with researchers, biotech companies, manufacturers, and public authorities in the EU and globally to detect new variants, provide incentives to develop new and adapted vaccines, speed up the approval process for these vaccines, and ensure scaling up of manufacturing capacities.
Commissioner for Health and Food Safety, Stella Kyriakides said: “We need to be prepared to adapt vaccines as quickly as possible to respond to new and potentially vaccine-resistant variants. Today we propose fast and flexible solutions to fast-track approvals, without compromising on safety and efficacy. With the HERA Incubator, our goal is to anticipate and be one step ahead.”
President of the European Commission, Ursula von der Leyen, said: “The HERA Incubator is to strengthen and accelerate the EU response to variants. We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus.”
The measure will now go to the European Parliament and Council for scrutiny before entering into force.