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CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.
CureVac announced results on June 17, 2021 of its second interim analysis of its Phase IIB/III study for its first-generation COVID-19 vaccine candidate, CVnCoV. The vaccine candidate demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria, reported the company, which pointed to the context of at least 13 variants of the virus in the study population subset that was assessed. The company communicated available data to the European Medicines Agency (EMA), and the Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. CureVac noted that at the conclusion of the study, all the data will be assessed to determine the most appropriate regulatory pathway.
In the HERALD study, which CureVac conducted with Bayer, approximately 40,000 participants in 10 countries in Latin America and Europe were enrolled. The second interim analysis included 134 cases, occurring at least two weeks after administration of the second dose. These cases were due to a range of variants, with only one case due to the original SARS-CoV-2 virus. Interim results suggest efficacy in younger participants.
“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,” said Dr. Franz-Werner Haas, Chief Executive Officer of CureVac, in the press release. “In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge.”
CureVac said it remains committed to COVID-19 vaccine development and pointed to partnership with GlaxoSmithKline to develop second-generation COVID-19 vaccine candidates based on new mRNA backbones. The newer candidates will include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in one vaccine. CureVac and GSK expect to enter clinical testing in the third quarter of 2021 with a second-generation vaccine candidate, with the goal of introducing the vaccine in 2022, subject to regulatory approval.