Sinovac Covid-19 Vaccine Gets Emergency Use Approval in China

Sinovac Biotech has received emergency use approval for its potential Covid-19 CoronaVac vaccine as part of a program in China to vaccinate high-risk groups, according to Reuters, citing a person familiar with the matter.

The company began developing the inactivated vaccine against Covid-19 in January this year in partnership with academic research institutes in China.

In preclinical studies, CoronaVac was found to be safe and protective of rhesus macaque monkeys. The findings were published in the journal Science.

Sinovac reported positive preliminary data from phase I / II clinical trials of the candidate vaccine in June this year. Results from randomized, double-blind, placebo-controlled trials demonstrated favorable immunogenicity and safety profiles.

The investigators did not report any serious adverse events in the phase I or II trials. In the phase II trial, the vaccine activated neutralizing antibodies 14 days after vaccination with a schedule of 0.14 days.

Earlier this month, the state pharmaceutical company China National Pharmaceutical Group (Sinopharm), a subsidiary of China National Biotec Group (CNBG), also announced approval of the emergency use of one of its Covid-19 vaccine candidates.

CNBG has two candidate vaccines in phase III trials and did not specify which of its candidates was approved for emergency use.

China has been vaccinating high-risk groups with investigational Covid-19 vaccines since July. The government may expand the emergency use program to prevent possible outbreaks in the coming months.

In June, employees of state-owned companies traveling abroad received one of two vaccines being developed by CNBG, the state-run Global Times reported.

The Chinese military had also granted approval to use CanSino Biologics’ candidate vaccine.

Currently, seven candidate vaccines against Covid-19 are in the final stages of testing globally, including four from China.