Policy & Regulation
Sinovac's Coronavac, SARS-CoV-2 Vaccine, Inactivated, Announces Approval for Phase I/II Clinical Trial in Adolescents and Children
24 September 2020 - - An inactivated COVID-19 vaccine candidate developed by China-based biopharmaceutical products provider Sinovac Biotech Ltd's (NASDAQ: SVA) Sinovac Life business was approved by the National Medical Products Administration for clinical trial in adolescents and children in August 10th, 2020, the company said.

This randomised, 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 said it 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.

Sinovac Biotech is a China-based biopharmaceutical company that focuses on the research, development, manufacturing and commercialization of vaccines that protect against human infectious diseases.

Sinovac's product portfolio includes vaccines against enterovirus71, hepatitis A and B, seasonal influenza, Quadrivalent Influenza vaccine, H5N1 pandemic influenza (avian flu), H1N1 influenza (swine flu), varicella vaccine and mumps.
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