FRANKFURT – Germany’s CureVac said yesterday it is no longer seeking European regulatory approval for its coronavirus vaccine, and will focus instead on a more promising second-generation jab.
The decision comes after final trial results in July confirmed that CureVac’s first vaccine had an efficacy rate of just 48%, well below that of faster rivals Pfizer-BioNTech and Moderna, whose vaccines are based on the same mRNA technology.
CureVac blamed the disappointing outcome on the many coronavirus strains circulating by then and on the varying immune responses across age groups.
It nevertheless submitted the data to the European Medicines Agency (EMA) to seek authorisation for the jab.
That approval request has now been withdrawn, CureVac said.
The biotech firm said EMA had indicated any green light would only come “in the second quarter of 2022”, by which time CureVac’s second-generation vaccine will have progressed to late-stage clinical trials.
EMA confirmed in a statement that it had ended its review of CureVac’s vaccine.
“Although EMA was speeding up its review of the data, some questions about the vaccine’s quality, impacting the benefit-risk balance of the vaccine, and the fact that results of the main study showed only a modest vaccine efficacy in adults still remained to be satisfactorily addressed,” the Amsterdam-based agency said.
CureVac chief executive Franz-Werner Haas said “the global fight against the pandemic continues”.
“But the requirements to effectively address the virus and emerging variants have changed.”
He said the company would use what it learned from the first vaccine candidate and “focus our resources on advanced second-generation vaccines”.
The second-generation jab is being developed with pharma giant GSK, which said the new vaccine has shown “strong improvement” compared with CureVac’s first effort.
“We welcome CureVac’s focus on the promising second-generation mRNA vaccine technology,” said Rino Rappuoli, GSK’s chief of vaccines research and development.
CureVac had secured a contract from the European Union for 405 million doses should its first-generation jab receive regulatory approval.
This advance purchase agreement “will cease”, CureVac said, but it remains in talks with the European Commission about the second-generation jabs.
Tuebingen-based CureVac was founded 20 years ago by mRNA pioneer Ingmar Hoerr.
The German government last year took a 23% stake in CureVac for €300 million (RM1.5 billion). – AFP, October 13, 2021
