Preliminary data from CureVac’s first-generation mRNA candidate vaccine showed that it was only 47% effective in preventing the severity of COVID-19.
The company late Wednesday and the shot signed by the European Commission to purchase the first 225 million doses at the end of last year does not meet the pre-specified statistical success scale in the Phase 2b / 3 study. , Said.
A study of 40,000 subjects, conducted across Latin America and Europe with the help of Bayer, continued final analysis “in the coming weeks,” the company said, with initial data submitted to the European Medicines Agency.
In close agreement, the price of CureVac shares fell by more than 50% in after-hours trading following the news, falling to less than $ 46.
The data are surprising following an early study in mice that CureVac showed promising results for a beta variant of the coronavirus, also known as the B.1.351 mutation, which first appeared in South Africa in March. Came as.
The latest results included 134 cases that occurred at least 2 weeks after the second dose of the vaccine. Although 57% of cases were due to so-called substances of concern, only one was identified as the original SARS-CoV-2 virus.
According to CureVac, this study suggested efficacy in younger participants, but not in participants over the age of 60.
“We are still planning to apply for approval,” said Franz Warner Haas, CEO of CureVac. Was told New York Times.
CureVac said the vaccine suggested age- and strain-dependent efficacy, as at least 13 mutants were circulating within a subset of the study population evaluated for the initial analysis.
“We were hoping for stronger interim results, but we recognize that it is difficult to demonstrate high efficacy with this unprecedented wide range of variants. For a final analysis involving at least 80 additional cases. As it continues, overall vaccine efficacy may change, “Haas said. statement..
Cureback seemed ready to push that shot to the European market with just the nickname of the time, as the block vaccination campaign suffered many setbacks from the offerings of Johnson & Johnson and Astra Zeneca. ..
Their deployment in Europe has suffered from rare but serious delays in delivery of blood clots and safety concerns. At the end of last year, the European Commission signed a supply agreement with CureVac to start 225 million doses, offering the option of securing an additional 180 million doses. Delivery is to begin when it is deemed safe and effective.
CureVac believed that Haas would submit an mRNA vaccine to European regulators as early as last month. Was told Reuters in early May. At the time, he said the cases among the study participants were “coming quickly”, bringing the mRNA maker closer to reading. But a month later, the news service reported that the European Medicines Agency is unlikely to make a decision on CureVac shots by August.
And with the EU vaccination campaign gaining momentum with shipments from Pfizer and its German partner BioNTech, CureVac’s shots Floating As an option for low- and middle-income countries where vaccination efforts have been delayed.
Still, CureVac continues to work with GlaxoSmithKline on second-generation candidates for the second half of 2022, as the blow to the first-generation vaccine does not prevent them from working on a pandemic. Said.
A GSK spokeswoman said the mRNA backbone of the new vaccine is different from previous generations where GSK was not involved in the development.
“GSK has partnered with CureVac to develop a second-generation mRNA vaccine based on preclinical data showing that immunogenicity increases up to 10-fold faster than first-generation,” a spokeswoman said. Stated in a statement to Fierce Biotech. “This data supports our intention to develop low-dose monovalent and multivalent vaccines to tackle new COVID-19 mutants.”
https://www.fiercebiotech.com/biotech/curevac-s-first-gen-covid-19-vaccine-shows-only-47-efficacy-market-value-halved-after-hours CureVac’s 1st generation COVID-19 vaccine unmarks with 47% effectiveness as stock prices are halved in after-hours trading