Brussels, Feb. 12, 2021 – The European Medicines Agency (EMA) has started a rapid review process for the COVID-19 vaccine made by German manufacturer CureVac, paving the way for potential market clearance.
The Amsterdam-based EU regulator is looking at preliminary laboratory results and early clinical trials, it said in a statement on Friday.
A rolling review allows companies to submit trial results as they become available and is quicker than a standard review process, according to EMA.
With the data provided, EMA’s scientists were to assess the safety of the shot as well as its ability to provoke an immune response to the novel coronavirus.
As soon as enough evidence is available, CureVac can apply for conditional market authorisation.
If granted, the drug can be rolled out on the EU market.
Three vaccines made by Pfizer-BioNTech, Moderna and AstraZeneca have so far been approved by EMA and the European Commission, which gives the final green light for the bloc.
Two others from Johnson & Johnson and Novavax are under review.
The European Union has a contract for up to 405 million doses of CureVac’s shot. (dpa/NAN)