CureVac Vaccine in EMA Rolling Review Process
German biotech CureVac has begun a rolling submission with the European Medicines Agency (EMA) for its mRNA-based Covid-19 vaccine candidate currently in Phase 2b/3 clinical trials with 35,000 people in Europe and Latin America.
The Tübingen-based company said the process was kicked off when it submitted the first data package consisting of pre-clinical data to the EMA and it passed the technical validation. During the review process, the agency will examine CVnCoV’s compliance with standards for efficacy, safety, and pharmaceutical quality as the basis for a conditional marketing application.
“We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is Covid-19,” said Lidia Oostvogels, vice president area head infectious diseases at CureVac. The biotech said earlier that it hopes to submit an application for marketing by mid-2021.
In recent weeks, the Curevac has announced plans to collaborate with compatriot Bayer on vaccine production and also said it would work together the UK’s GlaxoSmithKline (GSK) to develop vaccines to prevent infections with the Covid variants currently circulating worldwide.
Curevac announced earlier that, in line with its agreement to initially supply 50 million doses of potential variant vaccines to the UK, some production activity could be expected to take place in the country.
Author: Dede Williams, Freelance Journalist
