CureVac Pulls CVnCov from EMA Approval Process

13.10.2021 - CureVac is withdrawing its first-generation Covid-19 vaccine candidate, CVnCoV, from the current approval process with the European Medicines Agency. In a statement, the German biotech said the EMA had made it clear that there was no chance of the shot being approved before the second quarter of 2022. By this time, it expects candidates from the second-generation vaccine program it is pursuing with UK drugmaker GlaxoSmitKline (GSK) to have progressed to late-stage clinical development.

The Tübingen-based company said also that it will terminate its advance purchase agreement with the European Commission for 405 million doses of the vaccine post-approval. It added however, that it is assessing the possibility of leveraging CVnCoV commitments for its second-generation vaccine candidates and remains in contact with the Commission.

In mid-September, the biotech canceled its contracts with Wacker Chemie and Switzerland’s Celonic Group to toll manufacture CVnCov, while leaving the deals with Rentschler Biopharma and Novartis intact. It said at the time that contracts with Germany’s Bayer and Fareva of France would not be affected by the changes.

The company’s gradual decision to withdraw its first candidate followed disappointing results from the 40,000-subject international Phase 2b/3 trial with CVnCoV, completed earlier in the summer. A subsequent assessment confirmed previous findings that the candidate was only about 48% effective in preventing a Covid-19 infection of any severity.

Despite burying its first-generation vaccine hopes, CureVac said it plans to continue exploring additional formulations with GSK after the companies saw encouraging initial data from pre-clinical animal tests. These candidates, it said, are based on new mRNA backbones and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in single injection.

CureVac said the decision to withdraw from the EMA process reflected the evolving dynamics of the pandemic response toward a greater need for differentiated vaccines. “The global fight against Covid-19 continues, and we remain committed to making a difference with a safe and efficacious vaccine. This goal has not changed, but the requirements to effectively address the virus and emerging variants have changed,” said CEO Franz-Werner Haas.

Author: Dede Williams, Freelance Journalist