TAIPEI, Taiwan (AP) – China has given wider approval for Sinovac’s nationally manufactured coronavirus vaccine, expanding those who can receive it beyond high-risk, priority groups that are already licensed under an authorization emergency.
Regulators on Friday approved the firing of Sinovac Biotech Ltd, CoronaVac, which paves the way for general use, the National Medical Products Administration announced on Saturday
The Sinovac vaccine has already been sold in at least ten more countries and is given to people in at least five countries. In China, the shooting received emergency approval last July, allowing people such as medical workers and employees of state-owned enterprises to receive it.
Conditional approval means that the vaccine can now be administered to the general public, although the investigation is still ongoing. The company will need to submit follow-up data and reports of adverse effects after selling the vaccine to the market.
It is the second locally manufactured vaccine to which conditional approval is obtained. Beijing authorized the state-owned Sinopharm vaccine in December.
China has previously said that any COVID-19 vaccine will be free to its public, with the government facing the bill. Sinovac refused to give a figure for the price of each dose.
Both Sinovac and Sinopharm vaccines are two-dose inactivated vaccines, which rely on traditional technology that facilitates transport and storage than Pfizer vaccines, which require ultra-cold storage. This could make a difference for developing countries with fewer resources.
However, the Sinovac vaccine has also been the subject of intense scrutiny and criticism for lack of transparency, largely due to different efficacy data from different countries around the world. Officials in Turkey, where part of the stage 3 clinical trials were conducted, said the efficacy rate was 91.25%.
But in a much larger trial in Brazil, officials initially announced an effectiveness rate of 78%, but revised it to 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 published data from phase 1 and 2 of its vaccine.
Full data from the clinical trials of the Phase 3 trials will be published later in a peer-reviewed journal, said Pearson Liu, a company spokesman.
World health authorities have said any vaccine that is at least 50% effective would be helpful. The flu vaccine is usually about 50% effective. Experts have also said that it is significant that people who get sick despite taking the vaccine are less likely to suffer from severe symptoms.
Its Phase 3 clinical trials were conducted in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.