Update on CureVac COVID-19 Vaccine Phase 2b/3 Trial

CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity.

CureVac, a clinical-stage biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), has recently provided an update on the HERALD study for its first-generation COVID-19 vaccine candidate, CVnCoV.

The company presented the data to the European Medicines Agency (EMA).

The study, a phase 2b/3 trial, included 40,000 participants from 10 countries in Europe and Latin America and was conducted in partnership with the multinational pharmaceutical and life sciences company Bayer.

At the interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity. The therapy did not meet prespecified statistical success criteria.

An analysis suggested that the efficacy was due to age and the level of strains of the disease that are currently in circulation.

In total, there were 134 cases of COVID-19 in the interim analysis that occurred at least two weeks after administration of the second dose, and 124 of these were sequenced to identify the variant causing the infection.

Out of those 124 cases, only 1 of them was attributable to the original SARS-CoV-2 virus.

The company has stated that it is committed to the development of vaccines for COVID-19, and is continuing a partnership with GlaxoSmithKline to develop second-generation COVID-19 vaccine candidates.

“While we were hoping for a stronger interim outcome, we recognize that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging. As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change,” Franz-Werner Haas, chief executive officer of CureVac said. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.”