(SVA) will delay the release of late-stage trial results for its new crown vaccine until January next year. The reason for the delay is that the company will reportedly integrate data from Brazil with trial results from Indonesia and Turkey.
Kexin Biologics has four overseas clinical trial sites for its New Crown vaccine, and Bloomberg quoted a person familiar with the matter as saying that the tests are relatively independent and conducted under different protocols, rather than following the uniform norms that typically govern such trials. The source asked not to be named because the data is not publicly available.
Brazil was the first country to complete a Phase III clinical trial of the CoronaVac vaccine, the effectiveness of which was scheduled to be announced this Wednesday (Dec. 23). However, Kexing Holdings requested an additional 15 days to “analyze and integrate the results of the Kexing vaccine trials conducted in Indonesia and Turkey.
The Butantan Institute, KXH’s partner in Brazil, previously said that a report on the results of the Phase III tests was expected by mid-December. Later, Joao Doria, governor of the Brazilian state of São Paulo, said in mid-December that the results of the phase III trial would be released on Dec. 23, and he also hoped that the vaccine would be available in the state of São Paulo starting Jan. 25 next year. Kexing Bio’s new crown vaccine is in phase III testing in the state.
The repeated delays in releasing the results of Phase 3 tests of China’s Kexing vaccine in Brazil have raised questions about the vaccine’s effectiveness.
However, the Wall Street Journal quoted Comas, director of the Butantan Institute, as saying, “It’s impossible to have three effectiveness results for the same vaccine.” He said the delayed release had nothing to do with the vaccine’s effectiveness.
Brazilian President Jorge Bolsonaro has been critical of China and has repeatedly expressed doubts about the Kexin vaccine, saying it is not trustworthy because of its “origin.
In a report on Friday (Dec. 25), Bloomberg mentioned that Brazilian researchers said earlier this month when they delayed releasing full information on the Kexing Biological New Crown vaccine, which was found to be more than 50 percent effective. São Paulo State health Minister Jean Gorinchteyn provided a more specific statement Thursday, saying the vaccine “did not reach 90 percent” and was not comparable to those developed by Pfizer and Moderna Inc.
Turkish researchers said Dec. 24 that the effectiveness rate of Kexin’s new crown vaccine was 91.25, and Reuters reported that the country’s researchers believe that rate could rise based on data from later trials. Turkey is the second country in the world to report trial results for the Chinese vaccine candidate.
However, Moneycontrol reported on Friday that the Turkish test results were based on only 29 cases, which is not considered enough to draw definitive conclusions about the effectiveness of the vaccine. A spokesman for Kexing Biologicals had no comment.
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