In a 2b/3 clinical trial, CureVac said its COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria.
The interim results also suggest efficacy in younger participants but did not allow the company to conclude on efficacy in people 60 years old or older.
CureVac, based in TÜBINGEN, Germany, which also has operations in Boston, said the study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.
In total, 134 Covid-19 cases were assessed in the interim analysis. Out of these cases, 124 were sequenced to identify the variant causing the infection. The outcome confirms that only one single case was attributable to the original SARS-CoV-2 virus. More than half of the cases (57%) were caused by variants of concern. Most of the remaining cases were caused by other less characterized variants such as Lambda or C.37, first identified in Peru (21%) and B.1.621, first identified in Colombia (7%).
The HERALD study, conducted by Curevac in conjunction with Bayer, enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The second interim analysis included 134 cases, occurring at least two weeks after administration of the second dose. To identify strains causing COVID-19 infections within the trial, sequencing of virus variants has so far been performed on 474 COVID-19 cases, of which 124 fulfilled adjudication criteria and were included in the present efficacy analysis.
