The World Health Organisation has granted emergency approval for a new coronavirus vaccine to be distributed among developing countries.
The two-shot jab, made by drug maker Sinovac Biotech “meets international standards for safety, efficacy and manufacturing”, the WHO said in a statement on Wednesday morning (Australian time).
Director-General Tedros Adhanom Ghebreyesus said Sinovac was suitable for low-income countries because it could be easily stored.
The doses need only a standard refrigerator, unlike vaccines from Moderna and Pfizer, which must be stored at very low temperatures.
Sinovac is the second Chinese shot to receive emergency validation from the WHO.
A WHO emergency listing is a signal to countries’ regulators on a product’s safety and efficacy.
The status will also allow the shot to be included in COVAX, the global program to provide vaccines mainly for poor countries. It has faced major supply problems due to an Indian export suspension.
“It’s now crucial to get these lifesaving tools to the people that need them quickly,” Dr Tedros said.
Sinovac said that it had supplied more than 600 million doses of its vaccine at home and abroad as of end-May and more than 430 million doses have been administered.
Vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51 per cent of those vaccinated and prevented severe COVID-19 and hospitalisation in 100 per cent of the studied population, the WHO said.
The WHO’s separate Strategic Advisory Group of Experts had said previously in a review document that vaccine efficacy in multicountry phase three clinical trials ranged from 51 per cent to 84 per cent.
The independent panel of experts said in a statement it recommended Sinovac’s vaccine for adults over 18, with a second dose two-four weeks later.
There was no upper age limit as data suggested it is likely to have a protective effect in older people.
Indonesia’s health ministry said on May 12 that its study of 120,000 healthcare workers who had received the vaccine found it was 94 per cent effective at preventing symptomatic disease.
In a preliminary evaluation, the SAGE panel found the shot was efficacious in preventing COVID-19 in adults under 60 but that some quality data on the risk of serious adverse effects was lacking.
It cited evidence gaps in safety in pregnancy, and on safety and clinical protection in older adults, those with underlying disease and evaluation of rare adverse events detected through post-authorisation safety monitoring.
The SAGE experts, who issue policy recommendations to states and dosage guidelines, reviewed Sinovac clinical data in May.
Sinopharm, the first vaccine produced in China, was granted emergency approval on May 7.
China has already deployed hundreds of millions of doses of both Sinopharm and Sinovac vaccines at home and exported them to many countries, particularly in Latin America, Asia and Africa.
A third Chinese vaccine, produced by CanSino Biologics, has submitted clinical trial data but no WHO review has been scheduled.