Sinovac's COVID-19 Vaccine Gains China's Authorization

Beijing-based Sinovac Biotech Ltd. announced in a press statement issued on February 5, 2021, it had officially filed conditional market authorization for the CoronaVac vaccine with China’s National Medical Products Administration. Sinovac continues to actively seek regulatory approval for CoronaVac in other countries while contributing to making the COVID-19 vaccine accessible and affordable on a global basis to ensure the prevention and control of the COVID-19 pandemic.'

Additionally, the company released phase III study results. Sinovac had started its phase III trials on CoronaVac, its COVID-19 vaccine, on July 21, 2020. Trials were conducted in Brazil, Turkey, Indonesia, and Chile. There have been 25,000 participants enrolled in the trial across those four countries.

The phase III trials conducted in Brazil and Turkey evaluated the vaccine candidate's efficacy in healthcare workers who provide treatment to COVID-19 patients. Both trial studies were randomized, double-blind, and placebo-controlled. The two trials shared the same primary endpoint of an efficacy rate 14 days after the vaccination with either vaccine candidate or placebo.

As of December 16, 2020, 12,396 health workers were over 18 years old enrolled. A total of 253 positive cases were collected during the observation period. After 14 days following vaccination with 2 doses of vaccine following a 0, 14-day schedule, the efficacy rate against diseases caused by COVID-19 was 50.65% for all cases, 83.70% for cases requiring medical treatment, and 100.00% for hospitalized, severe, and fatal cases.

There are two stages of the phase III clinical trial in Turkey. Participants comprised health care workers in the first stage (K-1) and the general population in the second stage (K-2), with all participants ranging from 18 to 59. As of December 23, 2020, there were 918 participants enrolled in K-1 and 6,453 participants in K-2 for 7,371 participants.

Among them, 1,322 participants completed the two-dose vaccination and entered the 14-day observation period after receiving the second dose of the vaccination. Based on an analysis of 29 cases, the efficacy rate for COVID-19 prevention was 91.25% after 14 days following the two-dose vaccination, in adherence with the 0, 14-day schedule.