BEIJING (Reuters) – Sinovac Biotech said on Saturday that its unit’s COVID-19 vaccine was approved for use by the general public by China’s medical device regulator.
It marks the second vaccine approved for public use in China, after one developed by a Beijing institute affiliated with the China National Pharmaceutical Group (Sinopharm) was approved in December.
Both vaccines, as well as a third Sinopharm candidate, have already been used in China’s vaccination program, which administered more than 31 million doses, mainly targeting groups at higher risk of infection. A fourth CanSino Biologics candidate is being used by the military.
Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos have granted emergency authorization for the CoronaVac vaccine developed by Sinovac Life Sciences, Sinovac said in a press release.
The approval of the two-dose regimen by the National Medical Products Administration of China is based on the results of two months of advanced clinical trials abroad, from which the final analysis data has not yet been obtained, said Sinovac.
Its Beijing-based Sinovac Life Sciences unit is expected to be able to produce more than 1 billion doses a year in bulk form by February, the agency said.
Sinovac is also expanding its capacity to package vaccines in vials and syringes, which is currently lagging behind in its vaccine manufacturing capacity. It also outsourced the filling and finishing procedures to partners abroad.
China plans to provide 10 million doses of vaccine for COVAX, a global vaccine-sharing initiative supported by the World Health Organization for which Sinovac, Sinopharm and CanSino have signed up, said the Ministry of Foreign Affairs.
A Phase I and II trial in China showed that the vaccine can safely trigger an immune response for older participants and is also being tested in participants aged three to 17.
Sinovac warned, however, that the data for the protection rate among people aged 60 and over was “limited”.
“When the competent institutions … use this vaccine, the need to inoculate this product must be evaluated taking into account the health status and the risk of exposure for this age group”, he added.
VARIOUS EFFICIENCY RATES
The Sinovac vaccine is being tested in Phase III clinical trials in countries like Brazil, Turkey and Indonesia, where readings of varying effectiveness have been released separately, with insufficient details made available to the public.
The vaccine was found to be 50.65% effective against COVID-19 in the study in Brazil, which recruited 12,396 medical workers over the age of 18 to December 16 and recorded 253 cases, Sinovac said in a statement on Friday .
The success rate for the Turkish test was 91.25%, local researchers said, based on a preliminary analysis of 29 cases. There was an efficacy rate of 65.3% in the Indonesian trial.
The most rampant epidemic in Brazil and the focus of the study on medical professionals are among the factors that Sinovac believes may have reduced the rate of effectiveness seen in the data there, a person familiar with the matter told Reuters last month.
The Brazilian trial also found that the vaccine was 83.7% effective against the disease that requires medical treatment and 100% effective against hospitalization, severe cases and death in the same trial, Sinovac said on Friday.
The protection rate was almost 70% based on the observation of a smaller subgroup in the Brazil test, in which participants received both doses at a three-week interval, rather than two weeks apart for most participants, said Sinovac last month.
(Reporting by Roxanne Liu and David Stanway; editing by Kim Coghill and Jason Neely)