BEIJING (Reuters) – China’s Sinovac Biotech expects to begin analysing final-stage human trial data on its coronavirus vaccine candidate this year to decide whether it is effective enough to seek regulatory approval before trial completion, its chairman said on Thursday.
The plan puts the Chinese vaccine developer broadly on par with some of its Western rivals who are racing to evaluate efficacy of their vaccines just a few months into Phase 3 clinical trials.
U.S. drug maker Pfizer should know in October if its experimental vaccine works, while Moderna said interim analysis of its vaccine trial data is projected to occur in November.
Sinovac can start assessing CoronaVac’s ability to protect people as soon as researchers observe at least 61 trial subjects get sick from the disease, chairman and CEO Yin Weidong told a news conference.
Yin said the company hoped to supply its experimental coronavirus vaccine to more South American countries by outsourcing some manufacturing procedures to a partner in Brazil.
Global vaccine makers, such as Sinovac and AstraZeneca, have partnered with Brazil to conduct late-stage trials of their vaccine candidates in South America’s largest nation, battling with the third-highest tally of infections worldwide.
Sinovac plans to provide semi-finished products to its partner Instituto Butantan, which will perform filling and packaging and supply finished items to other South American countries.
China included Sinovac’s CoronaVac in its emergency use programme launched in July, but late-stage trials overseas have not been completed, arousing safety concerns among experts.
Brazil’s state of São Paulo is also likely to start to immunise its population with Sinovac’s vaccine in mid-December, pending regulatory approval, its governor has said.
Yin said the company was willing to collaborate and share data with other countries on vaccine emergency use if they need such programmes, and is in talks with Chile, among other nations, on conducting Phase 3 clinical studies.
“Different countries have their own options on emergency use authorisation,” said Yin, adding that he did not know if they would follow China.
Another vaccine candidate developed by a subsidiary of state-backed China National Pharmaceutical Group (Sinopharm), secured emergency use approval last week in the United Arab Emirates, where it is still being tested.
(Interactive graphic tracking global spread of coronavirus: https://graphics.reuters.com/world-coronavirus-tracker-and-maps)
(Reporting by Thomas Peter and Roxanne Liu in Beijing; Editing by Clarence Fernandez, Miyoung Kim and Nick Macfie)