Shares of Germany-based biopharmaceutical company,
CureVac N.V. ( CVAC Quick Quote CVAC - Free Report) , plunged 45.7% in the after-market trading hours after it announced disappointing data on its first-generation COVID-19 vaccine candidate, CVnCoV.
Results of the second interim analysis of its international phase IIb/III study in approximately 40,000 subjects (the HERALD study) showed that the candidate did not meet the prespecified statistical success criteria.
In this interim analysis, 134 COVID-19 cases were assessed. Out of these, 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. CVnCoV demonstrated an interim vaccine efficacy of only 47% against the COVID-19 disease of any severity.
The Data Safety Monitoring Board (DSMB) confirmed a favorable safety profile for CVnCoV. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.
The HERALD study enrolled approximately 40,000 participants in ten countries in Latin America and Europe. The study is being conducted by CureVac in conjunction with
Bayer ( BAYRY Quick Quote BAYRY - Free Report) . The second interim analysis included 134 cases, occurring at least two weeks after administration of the second dose.
The dismal results dampened hopes of a possible approval of the vaccine in the near term.
CureVac’s stock has gained 16.9% in the year so far against the
industry’s decline of 0.7%. 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 CVnCoV.
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.
There is a significant need for different vaccines across the globe to respond effectively to the emerging variants of COVID-19. Currently, players like
Pfizer ( PFE Quick Quote PFE - Free Report) / BioNTech and Moderna are leading the vaccine race with their approved vaccines.
CureVac currently carries a Zacks Rank #3 (Hold). You can see
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