The World Health Organization (WHO) said on Tuesday that it has approved a Covid-19 vaccine made by China’s Sinovac Biotech for emergency use, making it the second Chinese-produced shot to get the UN health agency’s endorsement.
The WHO’s approval gives countries, funders, procuring agencies and communities the assurance that it meets international standards for safety, efficacy and manufacturing, a statement from the WHO said.
It is the second Chinese vaccine to be approved by the WHO after it gave the green light to Sinopharm’s Covid-19 vaccine for emergency use, approving the vaccine to be rolled out globally, in early May.
The WHO’s emergency-use listing (EUL) is a prerequisite for the global Covax vaccine supply and international procurement. It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines.
“On the basis of available evidence, the WHO recommends the vaccine for use in adults 18 years and older, in a two-dose schedule with a spacing of two to four weeks,” the WHO statement said.
Vaccine efficacy results showed that the jab prevented symptomatic disease in 51% of those vaccinated and prevented severe Covid-19 and hospitalisation in 100% of the studied population.
Few older adults, over 60 years of age, were enrolled in clinical trials, so efficacy could not be estimated in this age-group.
The WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity information suggests that the vaccine is likely to have a protective effect in older persons.
“The decision further demonstrated that China not only has the willingness and the means to help in the global anti-pandemic fight, but the capability to do so,” Feng Duojia, president of the China Vaccine Industry Association, told Global Times on Tuesday.
The EUL procedure assesses the suitability of novel health products during public health emergencies. The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality.
Over 661.4 million doses of Covid-19 vaccines had been administered across China as of Monday, the national health commission said Tuesday.