February 21, 2021: To date, findings from Phase 3 studies involving the Sinovac Biotech COVID-19 vaccine candidate, CoronaVac, have not yet been published in the peer-reviewed scientific literature.
February 8, 2021: Sinovac Biotech, a China-based biopharmaceutical company focused on vaccine development, announced that its COVID-19 vaccine candidate, CoronaVac, has been granted a conditional marketing authorization from the China National Medical Products Administration. The vaccine is authorized for use in individuals aged 18 and above. The announcement made by the Company stated that authorization was based on findings from two months of follow-up data from Phase 3 studies. However, the announcement did not contain data concerning vaccine safety and efficacy.
February 5, 2021: Sinovac Biotech, a China-based biopharmaceutical company focused on vaccine development, announced findings from Phase 3 studies evaluating its COVID-19 vaccine candidate, CoronaVac. A total of 25,000 people recruited in Brazil, Turkey, Indonesia, and Chile have participated in these trials. (See Table 1 Under Phase 3 Studies for more detailed information about the design of these studies). Only data from Brazil and Turkey were included in the press release. The Company reported that in the trials conducted in Brazil and Turkey, the CononaVac vaccine was 50.65% effective in preventing all cases of COVID-19, 83.70% effective in preventing cases that required medical care, and 100% effective in preventing hospitalization and death. These estimates were based on people who had received two vaccine doses approximately 14 days apart. Although the announcement indicates that 253 cases of COVID-19 were observed, the efficacy analyses only included cases that occurred at least 14 days after participants received their second dose. And, at the time of the analysis, many study participants had not yet received their second dose. Therefore, it is not possible to determine how many study participants or cases were included in the efficacy analysis. We look forward to reviewing more detailed study findings.