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BEIJING: Sinovac Biotech said on Saturday (February 6) that its unit’s COVID-19 vaccine has been formally approved for use by the general public by China’s medical products regulator.
It is the second green-lit COVID-19 vaccine for public use in China, after a vaccine developed by a Beijing institute affiliated with the state-owned China National Pharmaceutical Group (Sinopharm) was approved in December.
READ: China’s Sinopharm COVID-19 Vaccine is Safe for Children and Teens: State Media
Both vaccines have already been used in China’s vaccination program primarily targeting key groups that are considered to be at increased risk of exposure to the virus.
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.
READ: Indonesia Approves China’s Sinovac Vaccine As COVID-19 Infections Rise
The approval of the two-dose regimen by the China National Medical Products Administration is based on the results of two months of overseas late-stage clinical trials, for which the final analysis data has not yet been obtained, Sinovac said. .
Sinovac Life Sciences is expected to be able to produce more than 1 billion doses per year in bulk ingredient form by February, it said in a statement.
It is expanding its capacity to fill vaccines into vials and syringes, which currently lags behind its vaccine manufacturing capacity.
VARIED EFFICIENCY RATES
Sinovac’s vaccine is being tested in phase III clinical trials in countries such as Brazil, Turkey, and Indonesia, where mixed efficacy readings have been published separately.
The vaccine was found to be 50.65 percent effective against the COVID-19 disease in the Brazil trial that recruited 12,396 healthcare workers over the age of 18 as of Dec. 16 and recorded 253 cases, Sinovac said in a statement Friday.
READ: China Sinopharm Vaccine Has 79% Protection Rate Against COVID-19
The trial’s success rate in Turkey was 91.25 percent, local researchers said, based on a preliminary analysis of 29 cases. There was a 65.3% efficacy rate in the Indonesian trial.
Brazil’s rampant epidemic and the trial’s focus on medical workers are factors that Sinovac believes may have lowered the efficacy rate 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 percent effective against disease requiring medical treatment and 100 percent effective against hospitalization, severe cases and death in the same trial, Sinovac said Friday.
The protection rate was nearly 70 percent as observed by a smaller subgroup in the Brazil trial, in which participants received the two doses three weeks apart instead of two weeks for most patients. participants, Sinovac said last month.
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