Shares of clinical-stage biopharmaceutical company,
CureVac N.V. ( CVAC Quick Quote CVAC - Free Report) , are down in premarket trading following the announcement of results from the final analysis of the HERALD study on its first-generation COVID-19 vaccine candidate, CVnCoV.
The phase IIb/III study enrolled approximately 40,000 participants in ten countries in Latin America and Europe. Statistical success criteria for the final analysis were met on the basis of 228 cases, occurring at least two weeks after the administration of the second dose. These included 68 additional adjudicated cases compared to the pre-defined 160 cases, as per trial protocol.
The sequencing of virus variants was performed on 588 COVID-19 cases to identify virus strains within the trial. Among these, 204 fulfilled adjudication criteria and were included in the efficacy analysis.
In the study, 15 COVID-19 variant strains were present for efficacy analysis and the original strain was almost completely absent.
CVnCoV demonstrated an overall vaccine efficacy of only 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms.
The vaccine generated significant protection among participants in the age group of 18 to 60, with an efficacy of 53% against disease of any severity and across all 15 identified strains. Data showed that protection against moderate to severe disease was calculated to be 77%. CVnCoV provided 100% protection against hospitalization or death in the same age group.
The study will continue to complete follow-up analyses for trial participants.
Last month, shares of the company plummeted after the results of the second interim analysis of the HERALD study showed that the candidate did not meet the prespecified statistical success criteria.
The study is being conducted by CureVac in conjunction with
Bayer ( BAYRY Quick Quote BAYRY - Free Report) .
CureVac’s stock has lost 9.4% in the year so far against the
industry’s growth of 1.5%. Image Source: Zacks Investment Research
We note that the company began the development of mRNA-based COVID-19 vaccine candidates in January 2020. CVnCoV is an optimized, non-chemically modified mRNA, encoding the prefusion stabilized full-length spike protein of the SARS-CoV-2 virus.
In December 2020, CureVac initiated the HERALD study with a 12µg dose of CVnCoV. In February 2021, it initiated a rolling submission with the European Medicines Agency (EMA) for the candidate.
Last month, CureVac along with partner
GlaxoSmithKline ( GSK Quick Quote GSK - Free Report) announced the first preclinical data in a rat model, which showed that its second-generation COVID-19 vaccine candidate, CV2CoV, induces high levels of antigen production as well as strong and dose-dependent immune responses in vaccinated animals. The vaccine is expected to progress into clinical testing in the third quarter of 2021.
There is a significant need for different vaccines across the globe to respond effectively to the emerging variants of COVID-19, which are creating havoc across the world. Currently, players like
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech and Moderna are leading the vaccine race with their approved vaccines, which are showing efficacy against emerging variants of concern too.
CureVac currently carries a Zacks Rank #4 (Sell).
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