CureVac’s COVID-19 mRNA vaccine shows 47% efficacy and is disappointing with preliminary results-Health News, Firstpost

German company CureVac released disappointing preliminary results from its clinical trials on Wednesday. COVID-19 (New Coronavirus Infection) Vaccines, dimming, hope it will help meet the great needs of the world.

In this study of 40,000 volunteers in Latin America and Europe, CureVac’s mRNA vaccine was estimated to be only 47% effective, one of the lowest ever reported. It was. COVID-19 (New Coronavirus Infection) Vaccine maker.The study continues while researchers monitor new cases of volunteers COVID-19 (New Coronavirus Infection) , The final analysis is scheduled for 2-3 weeks.

“We will do our best for the final read,” CureVac CEO Franz Warner Haas said in an interview. “We are still planning to submit 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 had a low efficacy rate, well below about 95% of the competing mRNA vaccines produced by Pfizer-BioNTech and Moderna, so it did not signal the adoption of CureVac shots.

“This is pretty devastating to them,” said Jacob Kierkegaard, a vaccine supply expert at the Peterson Institute for International Economics, a Washington think tank.

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, CureVac vaccines use less mRNA molecules per jab, reducing costs.

The test results released Wednesday were based on data from 135 sick volunteers. COVID-19 (New Coronavirus Infection) .. 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 percent effectiveness threshold to consider. COVID-19 (New Coronavirus Infection) Vaccine for emergency permit. 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 CureVac shots have yielded promising results in animal studies and early clinical trials.

“This is a bit of a headache,” Dean said.

Haas blamed the disappointing result of the high number of viral variants in the countries where the vaccine was tested. Of 124 COVID-19 (New Coronavirus Infection) Cases where company scientists sequenced genes, only one of the original version 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. CureVac volunteers were also infected with a variant that had not yet been carefully studied. Lambda, which has come to dominate Peru in the last few weeks, accounted for 21 percent of the sample.

Haas said the results should serve as a wake-up call to the threats that new variants may pose to vaccine efficacy. CureVac is not only looking for new RNA molecules that work for many variants at once, but also combining RNA molecules tailored to different variants in a single dose.

“It’s the reality of the new COVID, it’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. For example, in a study in Qatar, Pfizer-BioNTech was 87% to 89.5% effective against the first identified Alpha variant in the UK and 72.1% to 75% against Beta first discovered in South Africa. There was a% effect.

Haas also said that preliminary findings show that older people appear to have less protection from vaccines than younger volunteers. “Older people are not benefiting,” he said. However, it is not clear from the final results of the study whether CureVac can be confident about the differences between the two groups.

Prashant Yadav, a healthcare supply chain expert at the Center for Global Development in Washington, said the disappointing results disagree with the assumption that all mRNA vaccines are similar.

“There has been this question mark since the research on mRNA vaccines began,” he said. According to Yadav, the CureVac design may be due not only to the mutants, but also to their ineffectiveness.

Many vaccination experts have seen the possibility of cureback shots in much of the unvaccinated world, but new results cloud their outlook.

Kirkegaard predicted that it would be a challenge for CureVac to compete with another second wave. COVID-19 (New Coronavirus Infection) Vaccine made by Novavax. 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.

“I think it will be difficult for them to get a really important market in developing countries,” Kakegard said.

Carl Zimmer c.2021 The New York Times Company