Chinese biopharmaceutical firm Sinovac Biotech has partnered with Brazil-based Instituto Butantan to advance its Covid-19 vaccine candidate, CoronaVac, into Phase III clinical trials.
CoronaVac is an inactivated vaccine candidate, which demonstrated promising safety profile and offered protection to rhesus macaques monkeys in a preclinical study published in Science journal.
China’s National Medical Products Administration (NMPA) granted approval for Sinovac to perform Phase I/II clinical trials in the country. These trials are designed to assess the vaccine candidate’s safety, tolerance, dosage and immunisation schedule.
Meanwhile, the company is building a commercial vaccine manufacturing plant in China with an aim to produce up to 100 million doses of CoronaVac each year.
Under the latest clinical development collaboration agreement, Instituto Butantan agreed to sponsor Phase III trials of the Covid-19 vaccine candidate in Brazil.
The partners may enter additional agreements in the future for technology licensing, market authorisation and commercialisation of CoronaVac. Instituto Butantan expects the deals to ensure Brazilian population’s access to this vaccine.
Instituto Butantan clinical research medical director Dr Ricardo Palacios said: “Sinovac’s CoronaVac is based on a well-known, reliable technology suited to being incorporated into existing public health immunisation programmes in Brazil.
“Current epidemiology in Brazil and the experience of Butantan in clinical development will complement Sinovac’s efforts allowing accelerated progress toward development of a safe and effective immunisation against Covid-19.”
Brazilian officials noted that the clinical studies will commence next month and involve 9,000 volunteers. At a press conference, Sao Paulo governor Joao Doria said that Instituto Butantan signed a technology transfer agreement with Sinovac.
If the studies are successful, the vaccine is expected to be distributed by June next year.
Last week, Sao Paulo State University said that a Covid-19 vaccine being developed by the University of Oxford will be evaluated in 2,000 Brazilian volunteers beginning in the mid of this month.