A late-stage trial of a COVID-19 candidate vaccine from CanSino Biologics Inc has started in Russia, registration records showed, as the Chinese pharmaceutical firm steps up testing abroad to close in on regulatory approval.
The Ad5-nCoV vaccine already has approval for use by China’s military after early and mid-stage trials, and further late-stage trials are being lined up for Mexico and Saudi Arabia.
CanSino last month said it was in talks for opportunities to launch late-stage – or Phase 3 – trials in Saudi Arabia, Russia, Brazil and Chile.
The company has won a patent approval from Beijing for the vaccine, Chinese state media reported on Sunday, citing documents from the country’s intellectual property regulator.
CanSino and compatriots including Sinovac Biotech Ltd and China National Pharmaceutical Group Co Ltd (Sinopharm) are testing candidates overseas as China becomes less conducive for Phase 3 trials due to its small number of new COVID-19 cases.
The completion of Phase 3 trials is generally required for regulatory approval to distribute a vaccine for public use.
Russia’s state register for clinical trials showed a Phase 3 study expected to recruit 625 volunteers across eight medical institutes to test the safety and effectiveness of Ad5-nCoV began on Friday.
CanSino declined to offer more details on the Russian trial when contacted by Reuters, saying the information was confidential.
Russia was the first country to grant regulatory approval for public use of a COVID-19 vaccine, after less than two months of human testing. That vaccine uses adenovirus to carry antigen from coronavirus into human cells, an approach similar to that of Ad5-nCoV.
Last month, Russian biotech group Biocad said it was discussing producing in China a potential COVID-19 vaccine being developed by Russia’s Vector state virology institute.
With 927,745 cases, Russia has the world’s fourth-highest number of infections.