German vaccine developer, CureVac N.V. (NASDAQ: CVAC), may not be as fortunate as its domestic peer BioNTech SE (NASDAQ: BNTX), which along with its U.S. partner Pfizer, Inc. (NYSE: PFE), has found resounding success with its vaccine program.
What Happened: Results of the second interim analysis of CureVac’s international Phase 2b/3 study of its first-generation vaccine candidate showed vaccine efficacy of 47% against COVID-19 disease of any severity, the German company said in a statement.
The company also said the trial did not meet prespecified statistical success criteria.
CureVac clarified that initial analysis suggested age and strain-dependent efficacy. In addition, the Data Safety Monitoring Board confirmed a favorable safety profile for the vaccine candidate, codenamed CVnCoV, it added.
Out of the 134 COVID-19 cases assessed from a total study population of 40,000, only one case was attributable to the original strain of the SARS-CoV-2 virus, and more than half of the cases were caused by variants of concern. In contrast, the remaining cases were caused by less characterized variants.
The company said it had shared the data with the European Medicines Agency.
Why It’s Important: CureVac’s vaccine program disappointment comes at a time when a handful of vaccines are already in the market through the emergency authorization route.
The FDA has recently revised vaccine review guidelines, deciding not to entertain EUA applications. Instead, the agency is now contemplating review only through the full approval process route, necessitating more detailed data.
Incidentally, CureVac has a collaboration with Tesla, Inc. (NASDAQ: TSLA) for vaccine printers. In early April, Elon Musk tweeted suggesting CureVac is “a few months away from regulatory approval,” but deleted it soon after.
What’s Next: CureVac said it would continue with the final analysis of data from the study. Then, the totality of the data will be assessed for the most appropriate regulatory pathway.
“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, CEO of CureVac.
CureVac is also developing a second-generation COVID-19 vaccine candidate in partnership with GlaxoSmithKline plc (NYSE: GSK). These, according to the company, are based on mRNA technology and include potential variants in multivalent vaccine formats as well as combination vaccines for potential protection against multiple infectious diseases in one vaccine.
CureVac is backed by The Bill & Melinda Gates Foundation.
Price Action: CureVac shares, which debuted on the Nasdaq in Aug. 2020, have lost 38.30% to trade at $58.53 in the premarket session on the last check Thursday.
See more from Benzinga
© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.