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German biotechnology CureVac NV announced on Wednesday that its COVID-19 vaccine was only 47% effective in an advanced stage trial., which does not meet the main objective of the study and calls into question the supply of hundreds of millions of doses to the European Union.
The disappointing effectiveness of the injection known as CVnCoV emerges from an interim analysis based on 134 cases of COVID-19 in the study with some 40,000 volunteers in Europe and Latin America.
The World Health Organization has said that it is worth using vaccines that are more than 50% effective., although many of those already approved have a much higher rate.
External experts have found the data disappointing so far, but cautioned against direct comparison with other outlets already licensed to use it.
As the sole major purchaser of CureVac, the European Union obtained 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 Germany for an additional 20 million doses.
U.S.-traded CureVac shares fell 50.6% to $ 46.81 after the release.
CureVac said the study was hampered by the wide range of variants – at least 13 – found among the COVID-19 cases examined in the trial and that the end results may still change.
Of the COVID-19 cases reported in the test, 124 were sequenced to identify the variant causing the infection.
One case was attributable to the original version of the SARS-CoV-2 coronavirus that emerged in the Chinese city of Wuhan in late 2019., while 57% of cases were caused by highly transmissible variants, called interest.
The company added that interim results suggest the vaccine is effective in younger participants, but not in those over 60., the age group most at risk for severe COVID-19.
“While we would expect a more solid intermediate result, we recognize that it is difficult to demonstrate high efficacy in this unprecedented wide variety of variants. As we move towards the final analysis, with a minimum of 80 additional cases, the overall efficacy of the vaccine may change, ”said CEO Franz-Werner Haas.
The company said it sent the data to European Medicines Agency, which conducts an ongoing vaccine review.
“The study continues until the final analysis and the completeness of the data are evaluated to determine the most appropriate regulatory pathway,” CureVac said.
The stakes for CureVac and potential buyers of its vaccine in Europe have increased after age limits were imposed on the use of the Johnson & Johnson and AstraZeneca vaccines., due to an association with extremely rare but potentially fatal bleeding disorders.
The injection of CureVac was also expected to play an important role in low- and middle-income countries, which fell far behind in the global immunization campaign.
Deborah Fuller, professor of microbiology and vaccine specialist at Washington University School of Medicine, said CureVac treated “A quite different environment” from some of its rivals who had tried their vaccines while the original variant was still dominant.
CureVac testing has been done in 10 different countries, he noted, “The more countries you test, the more variants you will need to test.
Another problem could be the mRNA technology used in the injection of CureVac, which is slightly different from that used in the BioNTech-Pfizer and Moderna vaccines.said Mark Slifka, professor of microbiology and immunology at Oregon Health and Science University.
CureVac uses unmodified mRNA, which can trigger a different immune response in the body that affects efficiency, he said.
“It could be the variants, it could be the mRNA type, or it could be a combination of all of the above,” Slifka said.
Haas, the CEO, said the large number of variants CureVac found in their trial, with only one case of COVID-19 attributable to the original variant, “highlights the importance of developing next-generation vaccines as new viral variants continue to emerge”.
(With information from AP and Reuters)
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