The German company CureVac hopes to help meet the world’s major needs with disappointing preliminary results from clinical trials of the Covid-19 vaccine on Wednesday.
In this study of 40,000 volunteers from Latin America and Europe, the CureVacs mRNA vaccine was only 47% effective, one of the lowest ever reported by the Covid-19 vaccine manufacturer. It was presumed to be. The trial will continue while researchers monitor volunteers for new cases of Covid-19, with final analysis expected to take place in a few weeks.
In an interview, CureVac CEO Franz Warner Haas said he intended to work at full speed for the final read. We are still planning to apply for approval.
The company will initially apply to the European Medicines Agency. Last year, the European Union reached an agreement to purchase 405 million doses of vaccine if approved by the authorities.
However, an independent expert said CureVac would be difficult to recover. Natalie Dean, a biostatistician at the University of Florida, said vaccine efficacy may improve somewhat by the end of the trial. However, since most of the data is already in place, it is unlikely that the vaccine will prove to be very protective. It won’t change dramatically, she said.
It also did not signal CureVacs shots with a much lower efficacy rate than about 95% of the competing mRNA vaccines produced by Pfizer-BioNTech and Moderna.
Jacob Kierkegaard, a vaccine supply expert at the Peterson Institute for International Economics, a Washington think tank, said this was pretty devastating to them.
The news was disappointing to experts who wanted the company to be able to provide vaccines to low- and middle-income countries that didn’t have enough. CureVac had several advantages over other mRNA vaccines, including keeping it stable in the refrigerator for several months. In addition, compared to competitors, the CureVacs vaccine uses less mRNA molecules per jab, reducing costs.
The test results, released Wednesday, were based on data from 135 volunteers who became ill with Covid-19. An independent committee compared the number of sick people who received placebo with the number of people who received the vaccine. The vaccine appeared to provide some protection, but the statistical differences between the two groups were unclear, with an efficacy rate of 47%.
By comparison, annual influenza vaccination can reach 40-60 percent effectiveness. Both the World Health Organization and the Food and Drug Administration have set a 50% efficacy threshold to consider the Covid-19 vaccine for emergency use authorization. If CureVac remains at 47% in the final analysis, that criterion cannot be met.
The result surprised scientists. The vaccine is made from engineered mRNA, which is the same technique used in the Pfizer-BioNTech and Moderna vaccines. And CureVacs shots have yielded promising results in animal studies and early clinical trials.
According to Dr. Dean, this is a bit of a headache.
Dr. Haas blamed the disappointing result of the high number of viral variants in the countries where the vaccine was tested. Of the 124 cases of Covid-19 sequenced by company scientists, only one was caused by the original version of the coronavirus.
More than half of the cases were caused by mutations that were shown to be more contagious or could reduce the effectiveness of the vaccine. CureVacs volunteers were also infected with a variant that had not yet been carefully studied. Lambda, which has come to dominate Peru in recent weeks, accounted for 21 percent of the sample.
Dr. Haas said the results should serve as a wake-up call to the threats that new variants may pose to vaccine efficacy. That new Covid reality, that’s for sure, he said.
Moderna and Pfizer-BioNTech were tested last year before the variants emerged. This may partially explain their much higher efficacy rates. Still, studies have shown that actual effectiveness is only moderately reduced in the face of variants.
Many vaccination professionals have seen the potential for cureback shots in much of the unvaccinated world, but new results have clouded their outlook.
Dr. Kirkegaard predicted that CureVac would be difficult to compete with another Novavax second-wave Covid-19 vaccine. On Monday, Novavax reported that vaccines that did not need to be stored frozen reached 90% efficacy in trials in the United States and Mexico.
Dr. Kakegard finds it difficult for them to capture a truly important developing country market.
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