Germany's CureVac Withdraws COVID-19 Vaccine From EMA Approval Process

Germany's CureVac Withdraws COVID-19 Vaccine From EMA Approval Process

German biotech company CureVac announced on Tuesday its decision to withdraw its mRNA COVID-19 vaccine candidate from the European Medicines Agency's rolling review in favor of concentrating its efforts on developing second-generation mRNA vaccines

BERLIN (UrduPoint News / Sputnik - 12th October, 2021) German biotech company CureVac announced on Tuesday its decision to withdraw its mRNA COVID-19 vaccine candidate from the European Medicines Agency's rolling review in favor of concentrating its efforts on developing second-generation mRNA vaccines.

While there was initially much hope for the German firm's vaccine, the preliminary data of its late-stage clinical trials showed it was only 47% effective. The final data from the trials raised its effectiveness to 48%.

"CureVac N.V. ... today announced the strategic decision to focus its COVID-19 vaccine development towards the development of second-generation mRNA vaccine candidates in collaboration with GSK (GlaxoSmithKline) and to withdraw its first-generation COVID-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency (EMA)," CureVac said in a statement.

The EU drug regulator, for its part, confirmed the end of the approval process.

"The withdrawal means that EMA is no longer reviewing data on the vaccine and will not conclude this review. The company retains the right to request another rolling review or submit a marketing authorisation application in the future," the EMA said in a statement.

The EMA has so far authorized the vaccines by Pfizer, Moderna, AstraZeneca and Johnson & Johnson for use in the European Union.

Four vaccines are undergoing rolling review at the EMA at the moment: the United States' NVX-CoV2373 from NovaVax, China's CoronaVac from Sinovac, Russia's Sputnik V from the Gamaleya Institute, and France's Vidprevtyn from Sanofi Pasteur.