The WHO approves the Chinese Sinovac Covid-19 vaccine

The World Health Organization (WHO) has approved a COVID-19 vaccine from Sinovac Biotech for emergency use, the second China-produced shot to receive its approval, a WHO statement said on Tuesday.

A WHO emergency list is a signal to national regulatory authorities about the safety and efficacy of a product. This also allows the shot to be included in COVAX, the global program for delivering vaccines to mainly poor countries, which are facing major supply problems due to a suspension of Indian exports.

The independent panel of experts said in a statement that it recommends the Sinovac vaccine for adults over 18 years old, with a second dose 2-4 weeks later. There was no upper age limit as data suggested it was likely to have a protective effect in older people.

The WHO technical advisory group, which began meeting on May 5, made 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.

In some regions with the CoronaVac brand, it is the second Chinese-developed vaccine to receive such a WHO list to combat COVID-19, following the May 7 approval of an injection developed by the state-sponsored Sinopharm.

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

Sinovac said it had delivered more than 600 million doses of its vaccine domestically and abroad by the end of May, and more than 430 million doses had been administered.

The vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of vaccinees and prevented severe COVID-19 and hospitalization in 100% of the population studied, according to WHO.

The WHO’s separate Strategic Advisory Group of Experts (SAGE) had previously said in a review paper that the efficacy of vaccines in Phase III clinical trials in multiple countries ranged from 51% to 84%.

The Indonesian Ministry of Health said on May 12 that its survey of 120,000 health workers who received the vaccine found it to be 94% effective in preventing symptomatic illnesses.

In a preliminary review, the SAGE panel found that the injection was effective in preventing COVID-19 in adults under the age of 60, but that certain quality data on the risk of serious side effects was lacking.

It cited gaps in safety in pregnancy, safety and clinical protection in older adults, people with underlying disease, and evaluation of rare adverse reactions detected through post-authorization safety monitoring.

The SAGE experts, who make policy recommendations to states and dosage guidelines, reviewed Sinovac’s clinical data last month.

China has already used hundreds of millions of doses of both Sinopharm and Sinovac vaccines at home and exported them to many countries, especially Latin America, Asia and Africa.



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