TAIPEI, Taiwan (AP) – China has given broader approval for the domestically made Sinovac coronavirus vaccine, extending those who can get it beyond the high-risk and priority groups already allowed under an emergency cleanup.
Regulators gave conditional approval for Sinovac Biotech Ltd’s shot, CoronaVac, on Friday, paving the way for widespread use, the National Medical Products Administration announced in a statement Saturday.
The Sinovac vaccine has already been sold to at least 10 other countries and is being given to people in at least five other countries. In China, the shot was issued an emergency permit last July, allowing people such as medical personnel and employees of state-owned companies to receive it.
With conditional approval, the vaccine can now be given to the general public, although research is still ongoing. The company will have to provide follow-up data as well as reports of any side effects after the vaccine is marketed.
It is the second locally made vaccine to be conditionally approved. Beijing approved the state-owned Sinopharm vaccine in December.
China has previously said that any COVID-19 vaccine will be free to the public, with the government paying the bill. Sinovac declined to rate the price of each dose.
Both Sinovac and Sinopharm Injection are two-dose inactivated vaccines based on traditional technology that makes it easier to transport and store than Pfizer’s vaccines, which require ultra-cold storage. That can make a difference for developing countries with fewer resources.
However, Sinovac’s vaccine has also been subject to intense scrutiny and criticism for its lack of transparency, largely due to the differing efficacy data in different countries around the world. Officials in Turkey, where some of the phase 3 clinical trials took place, said the efficacy was 91.25%.
But in a much larger trial in Brazil, officials there initially announced an efficacy rate of 78%, but revised that to just over 50% after recording mild infections. The Brazilian portion of the trial enrolled 12,396 volunteers and recorded 253 infections, the company said in a statement Friday.
So far, the company has only released Phase 1 and Phase 2 data for its vaccine.
Full clinical trial data for the Phase 3 studies will be released later in a peer-reviewed journal, said Pearson Liu, a company spokesperson.
Global health authorities have said that any vaccine that is at least 50% effective would be helpful. The flu vaccine is generally about 50% effective. Experts have also said it makes sense that those who get sick despite taking the vaccine are still less likely to have severe symptoms.
The phase 3 clinical trials were conducted in Brazil, Chile, Indonesia and Turkey with a total of 25,000 volunteers.