China has given wider approval to the domestically manufactured Sinovac coronavirus vaccine, extending its use beyond the risk to priority groups of staff who may already receive it on the basis of the emergency authorization.
Regulators certified the conditional approval of CoronaVac, from Sinovac Biotech Ltd., on Friday, paving the way for its administration to the entire population, the National Administration for Medical Products announced on Saturday.
The Sinovac vaccine has already been sold in 10 other countries and is used in at least five other countries. In China, it received emergency approval in July, making it possible to immunize health care workers and state-owned employees, among others.
Conditional approval means that the vaccine can now be given to the general population, although studies continue. The pharmaceutical company must submit the follow-up data, as well as the reports of any side effects, after marketing.
This is the second domestically manufactured vaccine to receive conditional approval from Beijing after Sinopharm State in December.
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Both Sinovac and Sinopharm vaccines are two-dose vaccines that contain inactivated virus, a traditional technique that facilitates transport and storage compared to others such as that developed by Pfizer-BioNTech, which requires freezing temperatures. This could make a difference for developing countries with fewer resources.
The Sinovac vaccine has been heavily controlled and criticized for its lack of transparency. The drug manufacturer has announced different efficacy data in different countries. In Turkey, where part of the Phase 3 clinical trials were conducted, authorities said they are 91.25% effective.
But in a much larger study in Brazil, local officials initially announced an effectiveness of 78%, but later revised it to just over 50% after including mild infections. In the studies in Brazil, 12,396 volunteers participated and 253 infections were registered, the pharmacist explained in a statement on Friday.
Phase 3 CoronaVac tests are being conducted in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.