China has granted wider approval to the country-made Sinovac coronavirus vaccine, expanding its use beyond the risk and priority personnel groups it could already receive on the basis of its emergency authorization.
Regulators certified conditional approval of CoronaVac, from Sinovac Biotech Ltd, on Friday, paving the way for its administration to the entire population, the National Administration of Medical Products announced in a statement on Saturday.
The Sinovac vaccine has already been sold in about 10 more countries and is being used in at least five. In China, it received emergency approval in July, which allowed health workers and state-signed employees to be immunized, among others.
Conditional approval assumes that the vaccine can now be administered to the general population, although studies continue. The pharmaceutical company must submit the follow-up data, as well as reports of any secondary effects, after it has been marketed.
This is the second nationally manufactured vaccine to receive conditional approval from Beijing after the Sinopharm State signature in December.
You may be interested in:
Both Sinovac and Sinopharm are two-dose vaccines that contain the inactive virus, a traditional technique that facilitates transport and storage compared to others such as that developed by Pfizer-BioNTech, which requires deep-freezing temperatures. This could make a difference for developing countries with fewer resources.
Sinovac’s vaccine has been heavily scrutinized and criticized for lack of transparency. The pharmaceutical company announced different efficacy data in different countries. In Turkey, where part of the phase 3 clinical trials were conducted, authorities said it had an effectiveness of 91.25%.
But in a much larger study in Brazil, local officials initially announced an effectiveness of 78%, but later revised it downwards to just over 50% after including infections. mild. The trials in Brazil involved 12,396 volunteers and 253 infections were recorded, the pharmaceutical company said in a statement on Friday.
CoronaVac phase 3 trials are being conducted in Brazil, Chile, Indonesia and Turkey, with a total of 25,000 volunteers.