SINOVAC Approved to Initiate Clinical Trial for Its Omicron Containing COVID-19 Vaccine in Chile

Sinovac Biotech Ltd. (“SINOVAC” or the “Company”) (NASDAQ:SVA), a leading provider of biopharmaceutical products in China, announced that the Chilean Public Health Institute (Instituto de Salud Pública, ISP) approved a phase II clinical trial for its inactivated Omicron strain COVID-19 vaccine and trivalent COVID-19 vaccine (ancestral, Delta and Omicron variants) on August 31st. The clinical trial will evaluate the immunogenicity and safety of one booster dose of the two candidate vaccines in adults who had received two booster doses of CoronaVac®, mRNA, or adenovirus vector COVID-19 vaccine. This study is the world's first study researching multivalent inactivated COVID-19 vaccine.

In this phase II randomized, double-blind, multicenter clinical trial, 826 fully vaccinated adults will be recruited. Participants belonging to the heterologous scheme are individuals who had received two CoronaVac® doses, and two boosters of mRNA-based or viral vector-based vaccines, while participants of the homologous scheme had received four doses of CoronaVac®. Individuals from the heterologous scheme will randomly receive a booster dose with the Omicron, Trivalent, or CoronaVac® vaccines, while individuals from the homogeneous group will randomly receive a booster dose of the Omicron or the trivalent vaccines.

Mr. Weidong Yin, the Chairman, President, and CEO of SINOVAC said, “SINOVAC has made great progress collaborating with global partners in the development and manufacturing of the COVID-19 vaccine. We are proud of the fact that CoronaVac® can protect individuals as young as 6 months of age and this clinical approval will allow even better vaccine protection.”