BEIJING (Reuters) – Sinovac Biotech said on Saturday that the COVID-19 vaccine for its unit had been approved for use by the general public by China’s regulator of medical products.
It is the second vaccine approved for public use in China, after one developed in December by a Beijing Institute affiliated with the China National Pharmaceutical Group (Sinopharm).
Both vaccines, as well as a third candidate from Sinopharm, have already been used in China’s vaccination program, which has administered more than 31 million doses, mainly to groups at higher risk of infection. A fourth CanSino Biologics candidate is being used among military personnel.
Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos have given emergency permission for the CoronaVac vaccine developed by Sinovac Life Sciences, Sinovac said in a news release.
The approval of the two-dose regimen by the Chinese Medical Administration for Medical Products is based on results of two months of late-stage clinical trials abroad, from which the final analysis data have not yet been obtained, Sinovac said.
The Sinovac Life Sciences unit in Beijing is expected to be able to produce more than 1 billion doses per year in the form of a large ingredient by February.
Sinovac is also expanding its ability to fill the vaccine in vials and syringes, which currently has its production capacity for vaccine. It also outsourced filling and finishing procedures to overseas partners.
China plans to deliver 10 million vaccine doses to COVAX, a global initiative supported by the World Health Organization, to which Sinovac, Sinopharm and CanSino have applied, the foreign ministry said.
A Phase I and II trial in China showed that the vaccine can safely trigger the immune response for older participants and it is also being tested in participants aged three to 17 years.
However, Sinovac warns that the data for the protection rate among people aged 60 and older is “limited”.
“When the relevant institutions … use this vaccine, the need for vaccination of this product should be evaluated taking into account the health status and exposure risk of this age group,” he said.
DIFFERENT EFFECT RATES
The Sinovac vaccine is being tested in Phase III clinical trials in countries including Brazil, Turkey and Indonesia, where divergent efficacy readings have been disclosed separately without sufficient information available to the public.
The vaccine is 50.65% effective against COVID-19 disease in the Brazil trial, which on December 16 recruited 12,396 medical workers over the age of 18 and recorded 253 cases, Sinovac said in a statement Friday.
The success rate of the Turkey trial was 91.25%, local researchers said based on a preliminary analysis of 29 cases. There was a 65.3% efficiency in the Indonesian trial.
The more widespread epidemic in Brazil and the focus on medical workers in the trial is one of the factors that, according to Sinovac, could lower the efficiency rate of the data from 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 requiring medical treatment, and 100% effective against hospitalization, serious cases and death in the same trial, Sinovac said Friday.
The protection rate was almost 70% based on observation of a smaller subgroup in the Brazil trial, in which participants received the two doses at an interval of three weeks instead of two weeks apart for most participants, Sinovac said last month .
(Reporting by Roxanne Liu and David Stanway; editing by Kim Coghill and Jason Neely)