TAIPEI, Taiwan (AP) – China has given broader approval to the native Sinovac coronavirus vaccine, which has extended those who can receive it to the high-risk and priority groups already admitted under an emergency declaration.
Regulators granted conditional approval on Friday for the shot of Sinovac Biotech Ltd, CoronaVac, to clear the way for general use, the National Medical Products Administration said in a statement on Saturday.
The Sinovac vaccine has already been sold to at least ten other countries and is being administered to people in at least five other countries. In China, the shot was given in an emergency last July so people like medical workers and employees of state-owned enterprises could receive it.
The conditional approval means that the vaccine can now be given to the general public, although research is still ongoing. The company will be required to submit follow-up data, as well as reports of adverse effects after the vaccine has been sold on the market.
It is the second locally manufactured vaccine to be conditionally approved. Beijing approved Sinopharm’s state information in December.
China had earlier said any COVID-19 vaccine would be free to its public, with the government approving the bill. Sinovac did not want to give the price of each dose.
Both Sinovac’s shots and Sinopharm’s shots are two – dose inactivated vaccines, depending on traditional technology that makes it easier to transport and store than Pfizer’s vaccines, which require ultra – cold storage. It can make a difference for developing countries that have fewer resources.
However, the Sinovac vaccine is also subject to intense scrutiny and criticism due to lack of transparency, mainly due to the different efficacy data in different countries around the world. Officials in Turkey, where part of the phase 3 clinical trials were presented, said the efficiency rate was 91.25%.
But in a much larger trial in Brazil, officials initially announced an efficiency 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 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 stage 3 trials will be released 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 will be useful. The flu vaccine is usually about 50% effective. Experts have also said that it is significant that those who become ill despite the vaccination are less likely to suffer severe symptoms.
Its Phase 3 clinical trials were held in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.