June 16 (Reuters) – German biotechnology CureVac NV (5CV.DE) said on Wednesday that its COVID-19 vaccine was only 47% effective in a late-stage trial, missing the main goal of the study and questioning its potential delivery. of hundreds of millions of doses to the European Union.
The disappointing effectiveness of the shot known as CVnCoV emerged from a preliminary analysis based on 1
Efforts for CureVac and potential buyers of its vaccine in Europe had increased after age limits were imposed on the use of Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L) vaccines due to a link to extremely rare but potentially fatal coagulation disorders. Read more
CureVac’s shot was also expected to help in low-income and middle-income countries that have lagged far behind richer nations in the global immunization drive.
As CureVac’s only major supply agreement, the European Union secured up to 405 million doses of the vaccine in November, of which 180 million are optional. This was followed by a memorandum of understanding with a further 20 million doses with Germany. Read more
CureVac’s US traded shares fell 50.6% to $ 46.81 in trading after opening hours after the release of the data.
The company said at least 13 virus variants accounted for infections among the study population.
Out of the reported COVID-19 cases in the trial, 124 were sequenced to identify the variant that caused the infection, it said. One case was due to the original version of the SARS-CoV-2 coronavirus that originated in the Chinese city of Wuhan in late 2019, while 57% of cases were caused by more highly transmissible so-called variants of concern.
The company added that preliminary results suggest that the vaccine is effective in younger participants, but that it has not been shown to be effective in people over 60, the age group most exposed to severe COVID-19.
“While hoping for a stronger temporary outcome, we recognize that it is challenging to demonstrate high efficacy in this unprecedented wide variety of variants. As we move towards the final analysis with at least 80 additional cases, overall vaccine efficacy may change. “said CEO Franz-Werner Haas.
Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security, said the variants did not fully explain the effect number and he will still see data specifically on CureVac’s ability to stop serious illness, hospitalization and death.
“If it can do that, even with an efficacy of 47% in symptomatic disease, it is still a very valuable thing. That is all we have ever wanted vaccines to do,” he said.
Dr. Peter Hotez, a virologist and dean of the National School of Tropical Medicine at Baylor College of Medicine, said it was not clear if the problem was variant-specific or the vaccine’s inability to create high levels of neutralizing antibodies.
Since its inception in 2000, Tuebingen-based CureVac has focused on so-called messenger RNA (mRNA) technology, which is also behind the success of BioNTech (22UAy.DE) and partner Pfizer (PFE.N) as well as Moderna (MRNA) .O), whose vaccines have been shown to be more than 90% effective in preventing disease.
Prior to the advent of the highly effective vaccines, the US Food and Drug Administration had targeted at least 50% efficacy, which CureVac did not sign in the interim analysis. The World Health Organization had said they were looking for at least 70% efficiency.
While experiments with BioNTech / Pfizer and Moderna vaccines were carried out in the late phase, when the original version of the virus was dominant, real-world data have so far indicated only weaker protection against the new variants.
CureVac, supported by investors Dietmar Hopp, Gates Foundation and GlaxoSmithKline (GSK.L) as well as the German government, aimed to produce up to 300 million doses of the vaccine in 2021 and up to 1 billion doses in 2022.
Production partners include Celonic Group in Switzerland, Novartis (NOVN.S), Bayer (BAYGn.DE), Fareva, Wacker (WCHG.DE) and Rentschler Biopharma SE.
GSK has agreed to collaborate with CureVac on production as well as on the development of next-generation vaccines. A company spokesman said early preclinical data indicated a 10-fold increase in immunogenicity compared to the first. Read more
“We aim for the availability of another generation of COVID-19 vaccine as early as the second half of 2022, subject to regulatory approvals,” he said.
Reporting by Ludwig Burger Editing by Chris Reese
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