China has broadened approval for the domestically manufactured Sinovac coronavirus vaccine, extending its use beyond the high-risk and priority personnel groups who may already receive it based on their emergency permit.
Regulatory agencies certified the conditional approval of CoronaVac, from Sinovac Biotech Ltd., on Friday, paving the way for the administration for the entire population, the National Medical Products Administration announced in a statement Saturday.
Sinovac’s vaccine has already been sold in about 10 other countries and is used in at least five others. In China, it received an emergency permit in July, which made it possible, among other things, to immunize health workers and employees of state-owned companies.
Conditional approval means the vaccine can now be given to the general population, although studies continue. The pharmaceutical company must send the follow-up data, as well as reports of any side effects, after commercialization in the market.
This is the second domestically produced vaccine to receive conditional approval from Beijing, after that of state-owned Sinopharm in December.
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Both the Sinovac and Sinopharm vaccines are two dose vaccines containing inactivated virus, a traditional technique that facilitates transport and storage compared to others, such as the one developed by Pfizer-BioNTech, that requires deep-freezing temperatures. This could make a difference for developing countries with fewer resources.
Sinovac’s vaccine has been intensively researched and criticized for lack of transparency. The drug company announced different efficacy data in different countries. In Turkey, where some of the phase 3 clinical trials were conducted, authorities said it was 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 ingesting mild infections. 12,396 volunteers participated in the trials in Brazil and 253 infections were registered, the pharmacist said in a statement Friday.
CoronaVac Phase 3 studies are being conducted in Brazil, Chile, Indonesia and Turkey with a total of 25,000 volunteers.