European regulator begins examination of German CureVac vaccine



An employee works in the packaging area of ​​the GlaxoSmithKline (GSK) pharmaceutical factory in the town of Wavre (Belgium), where the CureVac vaccine is manufactured, on February 8, 2021


© Kenzo Tribouillard
An employee works in the packaging area of ​​the GlaxoSmithKline (GSK) pharmaceutical factory in the town of Wavre (Belgium), where the CureVac vaccine is manufactured, on February 8, 2021

The European Medicines Agency (EMA) announced on Friday the start of a “continuous review” of the German vaccine CureVac against covid-19, the first step towards a formal application for marketing authorization in the European Union (EU).

This decision “is based on preliminary results from laboratory studies (non-clinical data) and early clinical trials in adults,” the Amsterdam-based agency said in a statement.

“The review will continue until there is sufficient evidence for an official application for marketing authorization,” added the European regulator, which will evaluate data from other clinical trials “as soon as they are available.”

The EMA faces increased pressure to authorize new vaccines as soon as possible, at a time when all 27 Member States are struggling with delivery delays and supply difficulties for the first three vaccines authorized in the European Union.

Developed by the German biotech company of the same name, the CureVac vaccine, which pharmaceutical giant Bayer has committed to producing, is currently in phase 3 clinical trials.

Peter Kremsner, a professor at the Tübingen Institute of Tropical Medicine, who oversees the ongoing clinical study, estimated on German television on Friday that “the authorization (from the EMA) could come in April if all goes well.”

For its part, the agency stressed that it “cannot predict a general timetable”, although the evaluation of a possible application is facilitated by the “continuous review” process.

This procedure enables the EMA to analyze vaccine safety and efficacy data as it appears, even before the manufacturer submits a formal application for authorization.

Its aim is to speed up the evaluation of a marketing authorization application once it is made.

Two other vaccines are currently under “continuous review”: those developed by the US companies Johnson & Johnson and Novavax.

To date, the EMA has authorized the conditional marketing in the EU of three vaccines: Pfizer / BioNTech, Moderna and AstraZeneca / Oxford.

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