A volunteer receives a dose of CureVac or placebo during the clinical trial last March in Brussels.YVES HERMAN / Reuters
What was to be the fifth coronavirus vaccine approved in the European Union has given bad news on Wednesday night. The German biotech CureVac has reported that the effectiveness of its vaccine only reached 47% in preventing disease in any degree of severity in a preliminary analysis of phase 3 of the clinical trial. The pharmaceutical company had higher expectations: "The statistical criteria for success have not been met," the company said in a press release sent at 10:45 p.m. on Wednesday.
The CureVac immunization uses the same technology as BioNTech-Pfizer and Moderna, messenger RNA, but does not need to be stored at such cold temperatures.
Its approval was scheduled for late May or early June, but the company announced a few days ago that it would submit efficacy data to the European Medicines Agency (EMA) at the end of June.
The announcement that the efficiency does not reach 50% has caused the fall in the value of its shares on the stock market.
Both the World Health Organization (WHO) and the US drug agency, the FDA, consider that the minimum efficacy to authorize a vaccine against the coronavirus is 50%.
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The company analyzed 134 cases of covid among the 40,000 participants in the clinical study and sequenced 124 of them. More than half were caused by viral variants of the
worrisome
calls
. Only one of the cases analyzed corresponded to the original strain of SARS-CoV-2, the company explains. 21% of the positives corresponded to the lambda variant (C.37), identified for the first time in Peru and still little studied. In the coming days, another 80 more cases will be analyzed, so the percentage of 47% could vary, the company emphasizes.
CureVac has reported that preliminary analyzes suggest that efficacy is dependent on age and variants.
"The results suggest efficacy in younger participants, but have not allowed any conclusions to be drawn about the age group over 60," he notes.
“While we expected a more robust intermediate result, we recognize that demonstrating high efficacy across this unprecedented wide diversity of variants is challenging.
As we move towards the final analysis with a minimum of 80 additional cases, the overall efficacy of the vaccine may change, ”explained Franz-Werner Haas, CEO of CureVac, according to the press release.
"Additionally, the variant-rich environment underscores the importance of developing next-generation vaccines as new variants of the virus continue to emerge," he added.
CureVac has an agreement signed with the European Union to deliver at least 405 million doses (180 million are optional), of which around 10% would correspond to Spain. The clinical study of the vaccine, carried out in cooperation with Bayer, has had some 40,000 participants in ten Latin American and European countries, Spain among them. The United States tried to buy the biotech company last year but the German government reacted by acquiring 23% of the shares for 300 million euros to keep it a German company.
