CanSinoBIO's vaccine Photo: VCG
CanSino's recombinant novel coronavirus vaccine has been approved for emergency use by the Hungarian National Institute of Pharmacy and Nutrition (OGYEI), based on the interim results of the Phase III clinical trial, according to an official document CanSinoBIO sent to the Global Times on Monday.
The vaccine, named Ad5-nCoV, is effective with a single dose, which already gained approval for emergency use in Mexico and Pakistan in February. It is the first time that CanSino's vaccine has been approved for emergency use in a European country.
Reports said that the company will apply for emergency use of Ad5-nCoV in Chile in April, and an application for vaccine registration has also been submitted in Russia.
The number of doses to be provided to Hungary by CanSinoBIO and when they will be sent has not yet been revealed.
CanSinoBIO and the Mexican Ministry of Health signed a pre-purchase framework agreement to supply 35 million doses of COVID-19 vaccines to Mexico from the end of 2020 to 2021. So far, 5 million doses of COVID-19 vaccine stock have arrived in the country.
The interim results of the Phase III clinical trial of the vaccine shows that its efficacy against symptomatic COVID-19 cases is 65.28 percent 28 days after vaccination, and 68.83 percent after 14 days of vaccination.
For severe cases, the vaccine reported 90.98 percent and 95.47 percent efficacy respectively after 28 days and 14 days of single dose vaccination.
Designed for people aged above 18, the vaccine is also effective for the elderly. Interim results of the Phase III clinical trials carried out in Pakistan, Mexico, Russia, Chile and Argentina returned no serious adverse reactions, the company said. Incidence of adverse reactions in the elderly population is lower.
The vaccine is jointly developed by CanSino and a team led by military infectious disease expert Chen Wei from the Institute of Biotechnology under the Academy of Military Medical Sciences.
China's drug regulators also gave conditional approval for the mass use of the vaccine on February 25.
Global Times