A document seen by Reuters shows, WHO experts have voiced “very low confidence” in data given by Chinese state-owned drugmaker Sinopharm on its COVID-19 vaccine concerning the risk of serious side-effects in some patients, though overall confidence in its ability to prevent the disease.
World Health Organization did not give any quick response to an inquiry about any concerns linked to the Sinopharm vaccine, BBIBP-CorV. In Beijing, Sinopharm was not instantly reachable for comment outside working hours.
The WHO’s Strategic Advisory Group of Experts (SAGE) prepared the “evidence assessment” report for its review scheduled this week of the Sinopharm shot, approved by 45 countries and jurisdictions for use in adults, with 65 million doses applied. The experts review the evidence and give advice on policy and dosages associated with a vaccine.
The document comprises summaries of data from clinical trials in China, Bahrain, Egypt, Jordan and the United Arab Emirates.
According to the document, vaccine efficacy in multi-country Phase 3 clinical trials was 78.1 percent after two doses. This was a slight drop from 79.34 per cent stated previously in China
“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.”
Amid the “evidence gaps”, it cited data on protection against severe disease, duration of protection, safety for use in pregnant women and in older adults and identification/evaluation of rare adverse events through post-authorization safety monitoring.
“We have very low confidence in the quality of evidence that the risk of serious adverse events following one or two doses of BBIBP-CorV in older adults (?60 years) is low,” it said.
“We have very low confidence in the quality of evidence that the risk of serious adverse events in individuals with comorbidities or health states that increase risk for severe COVID-19 following one or two doses of BBIBP-CorV is low,” it added.
As the WHO technical advisory group currently reviews the vaccine for emergency use approval, the SAGE analysis was prepared, which would not only make the way for its use in the global COVAX vaccine sharing platform but also provide a crucial international endorsement for a vaccine developed in China.
On Wednesday, a WHO spokesman said that a decision on the listing was not anticipated.
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