Benzinga | Sep 23, 2020 08:36AM EDT

Sinovac Announces NMPA Approval Of Clinical Trial For Coronavac SARS-CoV-2 Vaccine In Adolescents and Children

Sinovac Biotech Ltd. (NASDAQ:SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced today that the inactivated COVID-19 vaccine candidate developed by Sinovac Life Sciences (Sinovac LS), or "CoronaVac", was approved by the National Medical Products Administration (NMPA) for clinical trial in adolescents and children in August 10th, 2020.

This randomized, double-blinded, and placebo-controlled phase I/II clinical trial among adolescents and children between the ages of 3-17 years old was approved by the Ethics Committee of the Hebei Provincial CDC on September 11, 2020, with the trial expected to commence soon. In this clinical trial, low dosage (300SU/dose) and medium dosage (600SU/dose) with two-dose immunization scheduled at 28-day intervals will be adapted. Sinovac has accelerated its vaccine development against the rapid spread of the coronavirus, so as to maximize the safety and health of citizens in China and other select countries around the world.

In recent months, the Company's Phase I/II clinical trials of CoronaVac in adults (18 to 59 years old) and elderly volunteers (60 years old and above) were conducted in Jiangsu and Hebei Provinces on April 16th and May 22nd, respectively. The vaccine candidate appeared to be well tolerated for different dosage and no serious vaccine-related adverse events were reported. Both seroconversion rates in adults and elderly volunteers were above 90%, indicating favorable safety and immunogenicity of CoronaVac.