Sinovac Biotech has received emergency use approval for its potential Covid-19 vaccine CoronaVac under a programme in China to vaccinate high-risk groups, according to Reuters citing a person familiar with the matter.
The company started developing the inactivated vaccine against Covid-19 in January this year in alliance with academic research institutes in China.
In preclinical studies, CoronaVac was found to be safe and provided protection to rhesus macaques monkeys. Findings were published in Science journal.
Sinovac reported positive preliminary data from the Phase I/II clinical trials of the vaccine candidate in June this year. Results from the randomised, double-blind and placebo-controlled trials demonstrated favourable immunogenicity and safety profiles.
Investigators did not report any severe adverse event in Phase I or Phase II trials. In the Phase II trial, the vaccine triggered neutralising antibodies 14 days following the vaccination with a 0,14 day schedule.
Earlier this month, state-owned pharmaceutical company China National Pharmaceutical Group (Sinopharm) subsidiary China National Biotec Group (CNBG) also announced emergency use approval of one of its Covid-19 vaccine candidates.
CNBG has two vaccine candidates in Phase III trials and did not specify which of its candidates secured the emergency use approval.
China has been vaccinating high-risk groups with investigational Covid-19 vaccines since July. The government may expand the emergency use programme to potentially prevent possible outbreaks in the coming months.
In June, employees at state firms travelling internationally were given one of the two vaccines being developed by CNBG, reported state media Global Times.
China’s military had also granted approval to use CanSino Biologics’ vaccine candidate.
Currently, seven vaccine candidates against Covid-19 are in final trial stages globally, including four from China.