Geneva — WHO experts have expressed “very low confidence” in the data provided by China’s state-owned pharmaceutical company Sinopharm for the COVID-19 vaccine regarding the risk of serious side effects in some patients, but the disease It shows overall confidence in its ability to prevent. The document that Reuters saw shows.
A World Health Organization spokesman said the document on the Sinofarm vaccine BBIBP-CorV is “one of many resources” for which recommendations have been made and will be published later this week.
In Beijing, Sinopharm was unable to contact immediately for comment during off-hours.
The “Evidence Assessment” document was prepared by the WHO Strategic Advisory Group (SAGE) for the assessment of China National Pharmaceutical Shots, approved by 45 countries and jurisdictions, and received 65 million doses. Experts will review the evidence and provide vaccine-related policies and dosage recommendations.
This document contains a summary of data from clinical trials in China, Bahrain, Egypt, Jordan and the United Arab Emirates.
Vaccine efficacy in Phase 3 clinical trials in multiple countries was 78.1 percent after two doses, the document states. This is a slight decrease from the 79.34 percent previously announced in China.
“We are confident that two doses of BBIBP-CorV will help prevent PCR-confirmed COVID 19 in adults (ages 18-59 years),” the document states.
However, “Phase 3 trials had a small number of participants with comorbidities (other than obesity), limiting the analysis of the safety of participants with comorbidities,” he added.
In the Evidence Gap, we quote data on protection against serious illness, duration of protection, safety of use in pregnant and elderly women, and identification / assessment of rare adverse events by post-approval safety monitoring. did.
“There is very little confidence in the quality of the evidence that there is a low risk of serious adverse events after one or two doses of BBIBP-CorV in the elderly (aged 60+),” he said.
“The quality of the evidence that increases the risk of serious COVID-19 after one or two doses of BBIBP-CorV and that the risk of serious adverse events in individuals with comorbidities or health conditions is low is very high. Has low reliability. “
The SAGE analysis was created because the WHO Technical Advisory Group is currently reviewing vaccines for emergency use authorization. This not only paves the way for use on the global COVAX vaccine sharing platform, but also China.
A WHO spokesman said Wednesday no decision on listing was expected.