The European Medicines Agency (EMA) announced on Friday that it would begin a “continuous review” of the German CureVac vaccine against Covid-19, the first step towards a formal marketing authorization request in the European Union.
The decision “is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults,” the Amsterdam-based agency said in a statement.
Pressure to authorize new vaccines
“The continuous review will continue until sufficient evidence is available for an official application for marketing authorization,” added the European regulator, adding that it will assess data from other clinical trials ” as soon as they are available ”.
The EMA faces increased pressure to clear new anti-Covid vaccines as quickly as possible, as the 27 member states grapple with delivery delays and supply difficulties for the first three vaccines authorized in the ‘European Union.
Bayer commits to producing CureVac
Developed by the German biotech company of the same name, the CureVac messenger RNA vaccine, which pharmacy giant Bayer has committed to producing, is currently in phase 3 clinical trials.
Peter Kremsner, professor at the Institute of Tropical Medicine in Tübingen, who is overseeing the ongoing clinical study, told German television on Friday that “the authorization (from the EMA) could come in April if all goes good “. The agency for its part underlined “not being able to predict a general timetable”, although the evaluation of a possible request is facilitated by the process of “continuous examination”.
This procedure allows the EMA to examine the safety and efficacy data of vaccines as they become available, even before a formal request for authorization is submitted by the manufacturer. Its purpose is to speed up the assessment of a marketing authorization application once it has been formulated.
“Continuous review” for two other vaccines
Two other vaccines are currently the subject of a “continuous review”, namely that developed by the American company Johnson & Johnson and that of the American group Novavax.
The EMA has so far given the green light for conditional marketing in the EU for three vaccines: those from Pfizer / BioNTech, Moderna and AstraZeneca / Oxford.