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CanSino Planning Ex-China 40,000-Patient Phase III Trial of COVID-19 Vaccine
CanSino Biologics (HK: 6185) of Tianjin is negotiating to start Phase III trials of its COVID-19 vaccine in Russia, Brazil, Chile and/or Saudi Arabia. The trial will enroll up to 40,000 volunteers, according to Dongxu Qiu, PhD, executive director and co-founder of the company at a weekend conference in Suzhou. Dr. Qiu also said the company's vaccine produced "much higher" efficacy in its 508-person China Phase II trial than in the Phase I test, though he didn't provide specific data.
In March, CanSino's COVID-19 candidate, Ad5-nCov, was the first China vaccine to begin clinical trials. Its adenovirus-based viral vector mechanism was developed in partnership with China's Academy of Military Medicine. The two entities built the COVID-19 vaccine on their adenovirus-based Ebola developed for the 2014-16 outbreak.
China approved the use of the CanSino's vaccine for military personnel before any Phase III testing has begun.
So far, two China-developed COVID-19 vaccines, one from Sinovac Biotech and the other from a Sinopharm subsidiary, have been approved to start Phase III testing.
In May, CanSino published positive results from the China Phase I trial of its COVID-19 vaccine in the British journal, The Lancet. In the study, the vaccine was immunogenic at 28 days post-vaccination with only mild or moderate side effects.
Dr. Qiu also said that CanSino is building a manufacturing facility, which will give the company capacity to produce 100-200 million doses of the vaccine per year. The facility is expected to be ready by early next year.
See our other articles on CanSino.