May 10, 2021

WHO lists Sinopharm COVID-19 vaccine for emergency use

The World Health Organization (WHO) has listed the Sinopharm coronavirus disease 2019 (COVID-19) vaccine (BBIBP-CorV) for emergency use, giving the green light for the vaccine to be rolled out globally.

The WHO noted that the easy storage requirements of Sinopharm’s inactivated vaccine make it highly suitable for low-resource settings. 

Meanwhile, the WHO said that its Strategic Advisory Group of Experts on Immunization (SAGE) has also completed its review of the vaccine. 

“On the basis of all available evidence, WHO recommends the vaccine for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks,” the WHO remarked, adding that “vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79%, all age groups combined.”

Despite the fact that vaccine efficacy could not be estimated in older adults (over 60 years) as few older adults were enrolled in clinical trials, the WHO said it is not recommending an upper age limit for the vaccine because preliminary data and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons.

“There is no theoretical reason to believe that the vaccine has a different safety profile in older and younger populations. WHO therefore recommends that countries using the vaccine in older age groups conduct safety and effectiveness monitoring to make the recommendation more robust,” the WHO noted. 

On the other hand, according to an assessment document released by SAGE, Sinopharm has conducted the Phase I/II safety study and the Phase III immunobridging pilot study of the vaccine in China, enrolling about 2,100 participants in each. It has also conducted another Phase III trial testing two vaccines (including BBIBP-CorV) in the United Arab Emirates, Bahrain, Egypt and Jordan. That trial involved 45,000 healthy adults overall. After a median follow-up of 112 days, interim data suggest BBIBP-CorV had a vaccine efficacy rate of 78.1%, with 21 cases of COVID-19 in the BBIBP-CorV group and 95 cases among those who received placebo.

The SAGE document also showed that the vaccine had an efficacy rate of 78.7% at preventing hospitalisations due to COVID-19, with 3 cases in the BBIBP-CorV group, and 14 cases for placebo. Additionally, 2 severe cases of COVID-19 were reported in the placebo group, and none among those who got Sinopharm's vaccine, but efficacy was not estimated.

SOURCE: World Health Organization
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