The World Health Organization (WHO) on Friday approved China’s state-owned Sinopharm CCP virus vaccine for emergency use for adults over 18.
This comes despite concerns raised by a separate group of WHO experts who said they had “very low confidence” regarding the risk of serious side-effects in some patients.
The Sinopharm jab’s inclusion on the WHO’s emergency use listing allows it to be included in COVAX, a global program to provide vaccines mainly for poor countries.
“This expands the list of [COVID-19] vaccines that COVAX can buy, and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine,” WHO Director-General Tedros Adhanom Ghebreyesus told a briefing.
The WHO had already given emergency approval to COVID-19 vaccines developed by Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, and more recently Moderna.
The decision to approve Sinopharm’s vaccine was taken by WHO’s technical advisory group, which began meeting on April 26 to review the latest clinical data as well as Sinopharm’s manufacturing practices.
But according to documents reviewed by Reuters, the Strategic Advisory Group of Experts (SAGE) this week voiced concern over data provided by Chinese state-owned drugmaker Sinopharm about the risk of serious side-effects in some patients. However, the group was confident in the vaccine’s ability to prevent disease.
Tedros said that, following the approval, SAGE had recommended that adults over 18 receive two doses of the Sinopharm vaccine.
SAGE found an efficacy rate of 78.1 percent after two doses in multi-country Phase 3 clinical trials, according to the document. The vaccine’s developer, Beijing Biological Products Institute, a unit of Sinopharm subsidiary China National Biotec Group, had announced an efficacy of 79.34 perecnt.
But SAGE found that after two doses the vaccine efficacy was 78.1 percent, a slight drop from the 79.34 percent announced by the developer, the document said.
“We are very confident that 2 doses of BBIBP-CorV are efficacious in preventing PCR confirmed COVID19 in adults (18-59 years),” the document said.
But it added: “Analysis of safety amongst participants with comorbidities (was) limited by the low number of participants with comorbidities (other than obesity) in the Phase 3 trial.
The WHO has said that as soon as next week it may reach a decision on the Sinovac jab, China’s other main vaccine against the COVID-19, the disease caused by the CCP (Chinese Communist Party) virus. Technical experts reviewed that vaccine on May 5.
China has deployed tens of millions of its Sinopharm and around 200 million Sinovac jabs to a number of countries, including in Latin America, Asia, and Africa. Although this week the Philippine’s president asked China to take back 1,000 donated doses of Sinopharm after he sparked criticism for getting that jab despite it not being approved by the country’s regulator.
Reuters contributed to this report.
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