Sinovac Biotech has obtained approval to commence the clinical trial of its inactivated Covid-19 vaccine against the Omicron strain of the SARS-CoV-2 virus in Hong Kong, China.
During last year, Sinovac worked to develop Covid-19 vaccines that act on the Gamma and Delta strains of the virus.
On 24 November last year, the Omicron variant was reported to World Health Organization (WHO), after which Sinovac obtained the strain in early December.
The company also carried out the development and preclinical research of the Omicron-specific vaccine, which showed to be safe and effective in animals.
In February this year, the company initiated the submission of clinical applications seeking approval to commence trial of the Omicron-specific Covid-19 vaccine in various countries and regions across the globe.
The latest development marks the first clinical approval in Hong Kong for Sinovac’s Omicron-specific vaccine.
In a press statement, Sinovac said: “Sinovac will continue its extensive cooperation with global partners to promote research on its vaccine based on the original Covid-19 strain against emerging variants, as well as clinical research on sequential immunisation of new variant strain vaccines, to evaluate their safety and effectiveness.”
In July last year, the company reported data from the Phase I/II trials of its inactivated Covid-19 vaccine, CoronaVac, which showed to elicit strong immune responses in healthy children and adolescents aged three to 17 years in China.
The safety, tolerability and immunogenicity of the vaccine was assessed in the double-blind, randomised, placebo-controlled trials enrolling 552 subjects.
The trial data also demonstrated that two intramuscular doses of the vaccine given at a gap of 28 days were found to be safe and well-tolerated in the paediatric participants.