WHO Approves Sinovac COVID-19 Vaccine, Becomes China's Second Registered Vaccine

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JAKARTA - The World Health Organization (WHO) said that it has approved a COVID-19 vaccine made by drugmaker Sinovac Biotech for an emergency use list, paving the way for a second Chinese vaccine to be used in poor countries.

As reported by Antara, Wednesday, June 2, the WHO emergency list is a signal to national regulators about the safety and efficacy of a product. The list will also allow the injections to be included in COVAX, a global program to provide vaccines primarily to poor countries, which are facing major supply problems due to India's export suspension.

An independent panel of experts said in a statement that they recommended the Sinovac vaccine for adults over 18 years, with a second dose 2-4 weeks later. There is no upper age limit as the data suggest it may have a protective effect on the elderly.

The WHO technical advisory group, which began meeting on May 5, came to the decision after reviewing the latest clinical data on the safety and efficacy of the Sinovac vaccine as well as the company's manufacturing practices.

With CoronaVac mark in several regions, it is the second vaccine developed by China to win the WHO list to combat COVID-19, following the May 7 approval of a vaccine developed by the Chinese government-backed Sinopharm.

A third Chinese vaccine, produced by CanSino Biologics, has submitted clinical trial data, but no WHO review is scheduled.

Sinovac said it had supplied more than 600 million doses of its vaccine at home and abroad by the end of May and more than 430 million doses.

Vaccine efficacy results show that the vaccine prevented symptomatic disease in 51 percent of those vaccinated and prevented severe COVID-19 and hospitalization in 100 percent of the population studied, WHO said.

The WHO's separate Strategic Advisory Group (SAGE) has said earlier in a review document that the vaccine's efficacy in multi-country Phase III clinical trials ranged from 51 percent to 84 percent.

Indonesia's Ministry of Health said on May 12 that its study of 120,000 health workers who had received the vaccine found that the vaccine was 94 percent effective at preventing symptomatic disease.

In the initial evaluation, the SAGE panel found that sun is effective in preventing COVID-19 in adults under 60 years of age, but some quality data on the risk of serious adverse events are lacking.

The evaluation cites gaps in evidence in safety for pregnancy, and in clinical safety and protection in older adults, elderly people, those with underlying disease, and evaluation of infrequently detected side effects through post-authorization safety monitoring.

SAGE experts, which issue state policy recommendations and dosing guidelines, reviewed Sinovac clinical data last month. China has deployed hundreds of millions of doses of Sinopharm and Sinovac vaccines in the country and exports them to many countries, especially in Latin America, Asia, and Africa.