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Disappointing results from CureVac’s COVID-19 vaccine as phase 2/3 study shows only 47% efficacy

Vaccine candidate failed to meet prespecified measure of statistical success in clinical trial

CureVac’s first-generation mRNA vaccine candidate CVnCoV is 47% effective at preventing COVID-19 of any severity, according to preliminary data from a phase 2/3 study evaluating the jab.

The German biopharma company revealed the lower vaccine efficacy in an interim analysis of data from the pivotal HERALD study in approximately 40,000 participants – although the jab did not meet the prespecified statistical success criteria, the study will continue to final analysis.

The results included 134 COVID-19 cases occurring at least two weeks after administration of the second dose. CureVac sequenced 124 of these cases to identify the variant causing the infection, finding that only one case was caused by the original SARS-CoV-2 virus strain.

The sequencing analysis found that 57% of the cases were caused by variants of concern (VoC), with the remaining cases caused by other ‘less characterised variants’.

The newest results also suggest vaccine efficacy in younger participants, although this did not extend to those aged 60 years and older.

“While we were hoping for a stronger interim outcome, we recognise that demonstrating high efficacy in this unprecedented broad diversity of variants is challenging,” said Franz-Werner Haas, chief executive officer of CureVac.

“As we are continuing toward the final analysis with a minimum of 80 additional cases, the overall vaccine efficacy may change. In addition, the variant-rich environment underlines the importance of developing next-generation vaccines as new virus variants continue to emerge,” he added.

CureVac has shared the initial results with the European Medicines Agency (EMA) and will analyse the final data for the most appropriate regulatory pathway.

In November 2020, the European Commission (EC) secured 405 million doses of CureVac’s COVID-19 vaccine candidate. The deal includes access to an initial 225 million doses of CureVac's vaccine, with the EC eligible to purchase a further 180 million.

Beyond CVnCoV, CureVac has partnered with GlaxoSmithKline (GSK) to develop the next generation of mRNA-based COVID-19 vaccines.

The deal will focus on developing a novel mRNA-based COVID-19 vaccine candidate, by using multivalent and monovalent approaches.

The next-generation vaccine will aim to offer broader protection against newly emerging variants, which have been reported to have the potential to reduce the efficacy of first-generation mRNA jabs.

Article by
Lucy Parsons

17th June 2021

From: Research



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