Friday, 12 August 2022

CanSinoBIO's single-dose COVID-19 vaccine gets approval in Chile

09 April 2021 | News

Marks vaccine's first approval in South America, following Mexico, Pakistan, China and Hungary

Photo Credit: Freepik

Photo Credit: Freepik

China based CanSino Biologics Inc. has announced that the Instituto de Salud Pública de Chile ("ISP") granted emergency use authorization for its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convidecia™).

This marks the first approval of Convidecia™ in South America and the first single-dose COVID-19 vaccine approved for emergency use in Chile.

On February 25, 2021, Convidecia™ was granted conditional marketing authorization by the National Medical Products Administration of China ("NMPA"), the first of its kind authorized in China. Globally, Convidecia™ received authorization for emergency use by the Hungarian National Institute of Pharmacy and Nutrition (OGYÉI) in March 2021, and by the Federal Commission for Protection against Sanitary Risks of Mexico and the Drug Regulatory Authority of Pakistan for adults aged 18 and above in February 2021.

In addition, on March 22, 2021, the NMPA granted approval of CanSinoBIO's clinical trial application for an inhaled version of COVID-19 vaccine, marking an important step forward in the Company's global fight against the COVID-19 pandemic as the virus continues to evolve.

The interim analysis data of phase III clinical trial of Convidecia™ shows that Convidecia™ has overall efficacy of 65.28% at preventing all symptomatic COVID-19 disease 28 days after single-dose vaccination, and 68.83% at preventing all symptomatic COVID-19 disease 14 days after single-dose vaccination. Convidecia™ has an efficacy of 90.07% at preventing severe disease 28 days after single-dose vaccination, and 95.47% at preventing severe disease 14 days after single-dose vaccination.

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