TAIPEI, Taiwan (AP) – China has given broader approval for the domestic vaccine against the coronavirus Sinovac, expanding those who can receive it beyond the high-risk and priority groups already allowed under an emergency authorization.
Regulators gave conditional approval for the injection of Sinovac Biotech Ltd, CoronaVac, on Friday, paving the way for general use, the National Medical Products Administration announced in a statement on Saturday.
The Sinovac vaccine has already been sold to at least 10 other countries and is being administered to people in at least five other countries. In China, the shot received emergency approval last July, allowing people like doctors and employees of state-owned companies to receive it.
Conditional approval means that the vaccine can now be given to the general public, although research is still ongoing. The company will be asked to provide follow-up data, as well as reports of any adverse effects after the vaccine is sold on the market.
It is the second locally produced vaccine to receive conditional approval. Beijing authorized Sinopharm’s state vaccine in December.
China previously said that any COVID-19 vaccine will be free to its public, with the government paying the bill. Sinovac refused to provide a value for the price of each dose.
Both the injection of Sinovac and Sinopharm are inactivated two-dose vaccines, relying on traditional technology that makes it easier to transport and store than Pfizer vaccines, which require ultracold storage. This can make a difference for developing countries that have less resources.
The Sinovac vaccine, however, has also been subject to intense scrutiny and criticism for lack of transparency, largely due to the different efficacy data in different countries around the world. Authorities in Turkey, where part of the stage 3 clinical trials were conducted, said the effectiveness rate was 91.25%.
But in a much larger study in Brazil, local authorities initially announced a 78% effectiveness rate, but revised that to just over 50% after including mild infections. The Brazil segment of the trial involved 12,396 volunteers and registered 253 infections, the company said in a statement on Friday.
So far, the company has released only stage 1 and 2 data for its vaccine.
Complete clinical trial data for stage 3 will be released later in a peer-reviewed journal, said Pearson Liu, a spokesman for the company.
Global health officials said any vaccine at least 50% effective would be useful. The flu vaccine is usually about 50% effective. Experts also said that it is significant that those who fall ill despite receiving the vaccine are less likely to experience severe symptoms.
Its stage 3 clinical trials was conducted in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.