The World Health Organization (WHO) yesterday released an evaluation of China’s Sinopharm COVID-19 vaccine, which, while affirming its high protective efficacy (78.1%) in people aged 18 to 59 years, also revealed that the vaccine’s protective efficacy and safety in people aged 60 years and older with comorbidities is inadequate.
The WHO is evaluating whether to grant emergency authorizations for two Chinese vaccines, Sinopharm BBIBP-CorV and Sinovac. Whether or not the Sinopharm vaccine is approved is expected to be announced by the end of this week.
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) released an evaluation report on Sinopharm vaccines on the 13th, stating that Sinopharm vaccines have been authorized for use in adults aged 18 and older in 45 countries or regions, and 65 million doses have been administered through emergency use programs.
According to the report, SAGE obtained three sets of clinical data for the Sinopharm vaccine, including Phase I and Phase II safety trials in China, Phase III clinical trials in four countries, including the United Arab Emirates, and a Phase III bridging trial in China.
According to the report, the results of the Phase III trial of the GMP vaccine showed that the efficacy of protection for people aged 18 to 59 years was 78.1%, and the efficacy of prevention of hospitalization was 78.7%; however, for people aged 60 years or older, patients with serious illnesses and comorbidities, the vaccine was classified as “not estimable”, according to the report. The report shows that these data are clearly inadequate.
In terms of safety, the report states that no safety concerns were identified in the clinical trial data, while data provided by the Chinese Communist Party authorities show that as of December 30, 2020, 1,453 adverse reactions had been reported after 5.9 million people were vaccinated in China, with no deaths.
The report noted that the national vaccine is still subject to further clinical trials on the rate of severe disease protection, duration of protection, the need for booster doses, protection against variant strains of the virus, pregnancy safety, protection in the elderly and those with underlying diseases, and monitoring of rare adverse reactions.
The report concludes that the efficacy of protection after two doses of the Chinese medicine vaccine in people aged 18 to 59 years is “highly plausible” and the safety is “moderately plausible”.
However, for those over 60 years of age, the report assessed the efficacy of protection as “low confidence” and the safety as “very low confidence” due to insufficient data provided.
In addition, the protective efficacy and safety of the national vaccine for people with co-morbidities and those with increased health status were also ranked as “very low confidence” by SAGE.
After SAGE released its report on the evaluation of GMP vaccines, it was not reported by Chinese media until press time.
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