China has given conditional approval for the general public use of a Covid-19 vaccine developed by Sinovac Biotech, making it the second home-made vaccine to get the green light for mass inoculation.
The vaccine, called CoronaVac, uses a chemically inactivated version of the virus to trigger an immune response. Sinovac received approval from China’s National Medical Products Administration on Friday, the Chinese drugmaker said in a statement on its website.
A vaccine developed by state-owned China National Pharmaceutical Group (Sinopharm) was approved in December.
The conditional approval for Sinovac’s two-shot vaccine regimen was based on two months of results of Phase III clinical trials overseas, the company said. It added that final analysis data from the trials has not been made available yet and efficacy and safety results require further confirmation.
Phase I and II trials in China for adults above 18 years old and seniors have been completed, the company said. So far, results have shown that the vaccine could safely trigger immune response from participants.
Sinovac said it has completed a second production line for the vaccine, which will double the annual production capacity to 1 billion doses.
CoronaVac was first approved for emergency use in China last June, mainly targeting high-risk groups and individuals.
Phase III trials started last July across Brazil, Turkey, Indonesia and Chile, with a total of 25,000 participants taking part.
As of December, CoronaVac was 50.65% effective against Covid-19 in the Brazil trial that had recruited 12,396 medical workers older than 18. It had also recorded 253 cases. The vaccine was found to have a 83.7% efficacy rate in cases that required medical treatment, and 100% effective against hospitalization, severe cases and death in the same trial, Sinovac said.
The efficacy rate from the trial in Turkey was 91.25%, it added, based on an interim analysis of 29 cases.
In the Indonesia trial, there was a 65.3% efficacy rate. The country’s food and drug agency has authorized the use of the vaccine for the elderly, according to Reuters. A previous rollout of Sinovac’s vaccine in the country targeted mostly medical workers and public servants.