Faster and simpler approval of COVID-19 vaccines

The EPP Group wants the European Parliament to approve a new procedure for vaccines against Coronavirus mutations. "With different mutated variants of the Coronavirus virus emerging, it is essential that we get this right. We can make the process clearer and simpler both for vaccine developers and the European Medicines Agency (EMA), and we can do so safely", said Roberta Metsola, the EPP Group MEP responsible for the topic, ahead of the adoption of the new procedure in the European Parliament today.

"The virus mutations are of great concern to us. We see a new mutation in India emerging. Vaccines work very reliably against the British variant B117, but with the Brazilian and South African virus variants, the effect of some vaccines is already limited and we have to expect that further mutations will emerge and that the vaccinations will then no longer provide for sufficient protection. This is why we must think ahead", said Peter Liese MEP, the EPP Group’s Spokesman for Health.

"One of the main elements of the new procedure will make it possible for the EMA to provide the market authorisation of the adapted vaccine earlier in the process, based on an initial dataset, and completed post-approval", explained Metsola, emphasising that it is crucial that the whole process remains safe. "We must under no circumstances compromise our existing high public safety standards. Our citizens must maintain confidence in vaccines", she stressed.

Liese explained that the blueprint for the new rules are the authorisations for annual flu vaccines, which also need to be regularly adapted. "We are not reinventing the wheel. Similar rules have already been successfully applied for many years and it is only right that we also apply them to the vaccines against Coronavirus", he concluded.