In this May 28, 2021 file photo, a healthcare worker prepares a dose of the Sinovac COVID-19 vaccine during a vaccination session for medical staff who work at private clinics in Caracas, Venezuela. (MATIAS DELACROIX/AP)
GENEVA – The World Health Organization (WHO) said on Tuesday it has approved a COVID-19 vaccine made by drugmaker Sinovac Biotech for emergency use listing, paving the way for a second Chinese shot to be used in poor countries.
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A WHO emergency listing is a signal to national regulators on a product's safety and efficacy. It will also allow the shot to be included in COVAX, the global program to provide vaccines mainly for poor countries, which faces major supply problems due to an Indian export suspension.
The independent panel of experts said in a statement it recommended Sinovac's vaccine for adults over 18, with a second dose 2-4 weeks later. There was no upper age limit as data suggested it is likely to have a protective effect in older people
The independent panel of experts said in a statement it recommended Sinovac's vaccine for adults over 18, with a second dose 2-4 weeks later. There was no upper age limit as data suggested it is likely to have a protective effect in older people.
The WHO's technical advisory group, which began meeting on May 5, took the decision after reviewing the latest clinical data on the Sinovac vaccine's safety and efficacy as well as the company's manufacturing practices.
Branded CoronaVac in some regions, it is the second Chinese developed vaccine to win such WHO listing to combat COVID-19, after the May 7 approval of a shot developed by state-backed Sinopharm.
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A third Chinese vaccine, produced by CanSino Biologics, has submitted clinical trial data, but no WHO review has been scheduled.
Sinovac said that it had supplied more than 600 million doses of its vaccine at home and abroad as of end-May and over 430 million doses have been administered.
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51 percent of those vaccinated and prevented severe COVID-19 and hospitalization in 100 percent of the studied population, the WHO said.
The WHO's separate Strategic Advisory Group of Experts (SAGE) had said previously in a review document that vaccine efficacy in multi-country Phase III clinical trials ranged from 51 percent to 84 percent.