Singapore’s Health Sciences Authority starts review of Sinovac COVID-19 vaccine
Sinovac Biotech said on Saturday that the COVID-19 vaccine in its division has been approved for use by the general public by the Chinese medical product regulatory authority..
This is the second vaccine approved for public use in China after a vaccine developed by the Beijing Institute, part of the state-owned China National Pharmaceutical Group (Sinopharm), was approved in December..
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 targeting groups at higher risk of infection. The fourth candidate from CanSino Biologics is used among the PRC military personnel.
Indonesia, Turkey, Brazil, Chile, Colombia, Uruguay and Laos have issued an emergency authorization for the CoronaVac vaccine developed by Sinovac Life Sciences, Sinovac said.
According to the biopharmaceutical company, the approval of the two-dose regimen by the National Medicines Administration of the People’s Republic of China is based on the results of two months of clinical trials in advanced stages of trials abroad, for which final analysis data has not yet been obtained..
Its Beijing-based Sinovac Life Sciences division is expected to be able to produce over 1 billion doses per year in bulk ingredients by February..
Sinovac is also expanding its capacity to fill vaccine vials and syringes, which currently lags behind its production capacity. The company also transferred some production processes to its foreign partners..
China plans to provide 10 million doses of COVAX vaccine to a World Health Organization (WHO) -backed global vaccine exchange initiative that Sinovac, Sinopharm and CanSino have applied to join, the Ministry of Foreign Affairs said..
Phase I and II trials in China have shown the vaccine can safely induce an immune response in older participants, and it is also being tested in participants aged 3-17.
However, Sinovac warned that data on the degree of protection among people aged 60 and older «limited».
Sinovac vaccine is being tested in phase III clinical trials in foreign countries, including Brazil, Turkey and Indonesia, where various efficacy values have been published separately, without sufficient information being released..
The vaccine was found to be 50.65% effective against COVID-19 in a study in Brazil, which as of December 16, involved 12,396 healthcare workers over 18 and reported 253 cases, the company said in a statement..
According to local researchers, based on a preliminary analysis of 29 cases, the trial success rate in Turkey was 91.25%. In a study in Indonesia, the efficiency was 65.3%.
A person familiar with the matter told Reuters last month that Brazil’s more serious epidemic and the focus on research by healthcare professionals are some of the factors Sinovac believes may have reduced the level of effectiveness seen in the data..
A trial in Brazil also found the vaccine to be 83.7% effective against a medical condition requiring medical treatment and 100% effective against hospitalizations, severe cases and death in the same trial, the company said..
The protection rate was nearly 70% based on observation of a small subgroup in a study in Brazil in which participants received two doses at three week intervals rather than two weeks apart for most participants, Sinovac Biotech said last month..