TAIPEI, Taiwan (PA) – China has granted wider approval for the domestically manufactured Sinovac coronavirus vaccine, extending those who can receive it beyond the high-risk, priority groups already allowed following an emergency authorization.
Regulators gave conditional approval to the shooting of Sinovac Biotech Ltd, CoronaVac, on Friday, paving the way for general use, the National Administration for Medical Products announced on Saturday in a statement
The Sinovac vaccine has already been sold in at least 10 other countries and is given to people in at least five other countries. In China, the shooting received emergency approval in July last year, allowing people such as medical workers and state-owned employees 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 need to submit follow-up data as well as reports of any side effects after the vaccine is sold on the market.
It is the second locally produced vaccine to receive conditional approval. Beijing authorized the Sinopharm state vaccine in December.
China has previously said that any COVID-19 vaccine will be free to its public, with the government paying for the bill. Sinovac declined to provide a figure for the price of each dose.
Both the Sinovac vaccine and the Sinopharm vaccine are two-dose inactivated vaccines, based on traditional technology that makes it easier to transport and store than Pfizer vaccines, which require ultra-cold storage. This could make a difference for developing countries with fewer resources.
However, the Sinovac vaccine has been heavily monitored and criticized for its lack of transparency, largely due to different efficacy data from different countries around the world. Officials in Turkey, where some of the stage 3 clinical trials were conducted, said the efficacy rate was 91.25%.
But in a much larger study in Brazil, officials there initially announced an effectiveness rate of 78%, but revised it to just over 50% after including mild infections. The Brazilian segment of the trial enrolled 12,396 volunteers and registered 253 infections, the company said in a statement on Friday.
So far, the company has only released data from stage 1 and stage 2 for its vaccine.
Full clinical trial data for stage 3 trials will be published later in a peer-reviewed journal, said Pearson Liu, a company spokesman.
Global health authorities have said that any vaccine that is at least 50% effective would be useful. The flu vaccine is generally about 50% effective. Experts also said that it is significant that those who get sick despite receiving the vaccine are still less likely to suffer from severe symptoms.
Its 3 clinical stages took place in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.