Sinopharm’s Vaccine Nears Emergency-Use Approval by WHO

World Health Organization experts said one of China’s Covid-19 vaccines is 78.1% effective in adults ages 18-59 years old but found that there is insufficient trial data to demonstrate effectiveness in protecting older people and people with underlying medical conditions.

The United Nations organization’s Strategic Advisory Group of Experts on Immunization published the assessment in a report on BBIBP-CorV, the Covid-19 vaccine developed by state-owned China National Pharmaceutical Group Corp. (Sinopharm). The finding could play a key role in approval by the World Health Organization (WHO) of Sinopharm’s vaccine for emergency use, making it eligible for deployment in lower-income nations through the Covid-19 Vaccines Global Access (Covax) initiative, which is suffering a supply crunch.

The WHO is expected to clear vaccines made by Sinopharm and Sinovac Biotech Ltd., another Chinese company, by the end of this week, said Mariangela Simao, WHO assistant director-general for drug access, vaccines and pharmaceuticals, at a press conference Monday. If both vaccines receive the WHO green light, China could become the world’s largest vaccine supplier, providing 2 billion doses this year.

The agency’s 78.1% efficacy finding for the Sinopharm vaccine is close to the Chinese company’s previous self-assessment showing 79% effectiveness. Experts said the vaccine is effective at preventing confirmed Covid-19 in adults ages 18-59 years, moving the Chinese vaccine closer to receiving WHO authorization.

But the WHO experts said they have “low confidence” in the quality of evidence that two doses of the vaccine are effective in protecting adults ages 60 and older. They also have “very low confidence” in the quality of evidence that the risk of serious adverse events following one or two doses of the vaccine in older adults and people with comorbidities or poor health conditions, the report said.

Sinopharm’s vaccine was approved in China for general use in December 2020. According to Sinopharm’s data, 5.9 million people received the vaccine by the end of last year. Among them, 1,453 reported adverse effects and eight had serious adverse reactions.

Relatively few people ages 60 and older were included in the trial data. The data showed only 209 elderly people in the vaccinated group and 206 in the placebo group. As there were no confirmed cases that age group, the data didn’t provide the vaccine’s efficacy rate for the group.

Due to the small number of people with hypertension and diabetes in the trial data, the calculation of protection rates for these populations is uncertain, the report said.

Several studies of the vaccine are underway in the United Arab Emirates, Bahrain, Pakistan, Peru and Argentina. In addition, the vaccine is under extensive safety monitoring in China for the elderly and patients with underlying diseases, the report said.

China has been speeding up its nationwide vaccination program in a drive to protect its population. As of April 10, China administered more than 164 million doses of Covid-19 vaccines in its population of 1.4 billion.

The government has so far approved five coronavirus vaccines for public use. More than 60 countries have authorized the use of Chinese vaccines, according to state media.

Contact reporter Denise Jia (huijuanjia@caixin.com) and editor Bob Simison (bobsimison@caixin.com)

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