China’s Sinovac Biotech Ltd launched a late-stage human trial on Tuesday that will involve as many as 1,620 patients in Indonesia for a COVID-19 vaccine candidate that it is developing with Indonesian state-owned peer Bio Farma.Separately, Sinovac released details on Monday from a mid-stage, or Phase 2, study in which it said the vaccine candidate appeared to be safe and induced detectable antibody-based immune responses in subjects.The candidate, known as CoronaVac, is among a few potential vaccines that have entered late-stage trials for a large-scale study to gather proof of efficacy for regulatory approval.
CoronaVac is already undergoing a late-stage trial in Brazil and Sinovac expects to also test it in Bangladesh.Sinovac’s Indonesia trial comes as Southeast Asia’s most populous country grapples with spiking infection numbers, with over 127,000 cases recorded as of Tuesday. The trial has so far recruited 1,215 people and will last six months.
Testing of CanSino’s COVID-19 Candidate Vaccine Begins in Russia
Russia’s Petrovax has started a late-stage trial of a COVID-19 candidate vaccine from CanSino Biologics Inc in the country, records show, as the Chinese drug 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.This is the first trial of a potential vaccine developed by a foreign company to take place in Russia, while the country prepares to start mass production of its domestic shot developed by Moscow’s Gamaleya Institute.