05.10.21

Sinopharm’s COVID-19 Vaccine Granted WHO Emergency Listing

Source: FirstWord

The World Health Organization (WHO) on Friday approved Sinopharm’s COVID-19 vaccine for emergency use, paving the way for millions more doses to be included into the COVAX program in the coming weeks or months for rollout in developing countries, according to a FirstWord report. The decision makes BBIBP-CorV the first COVID-19 vaccine developed by a non-Western country to win WHO backing, following previous emergency listings given to Pfizer/BioNTech, AstraZeneca, Johnson & Johnson and most recently Moderna.

Sinopharm’s adjuvanted, inactivated virus vaccine, which is administered as two doses given 21 to 28 days apart, has already been authorised by regulators from China and other countries in recent months. However, the Chinese company has released very little data publicly, aside from some efficacy numbers for BBIBP-CorV, which was developed by its Beijing Institute of Biological Products. Sinopharm also has another COVID-19 vaccine, dubbed WIBP-CorV, developed by the Wuhan Institute of Biological Products. The WHO was given access to data before its announcement, but there is limited data on how well BBIBP-CorV will work against SARS-CoV-2 variants.

Efficacy of 78.1% in multi-country trial

Sinopharm has conducted the phase 1/2 COVIV-01 safety study and the phase 3 COVIV-05 immunobridging pilot study of BBIBP-CorV in China, enrolling about 2100 participants in each. It has also conducted another phase 3 trial, dubbed COVIV-02, testing both BBIBP-CorV and WIBP-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, according to an assessment document released by the WHO’s Strategic Advisory Group of Experts on Immunization (SAGE).

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

‘Low confidence’ in efficacy for older adults

In the assessment document, SAGE said it had a “high level of confidence” that BBIBP-CorV protects people ages 18 to 59, but had only a “low level of confidence” regarding the vaccine’s efficacy among those 60 or older. In terms of safety, SAGE members said they were “moderately confident” that the risk of serious adverse events following one or two doses of BBIBP-CorV in adults 18 to 59 years is low, but had “very low confidence” in the available data about serious side effects in the 60-plus group. SAGE members also said they have “very low confidence” in the quality of the evidence for BBIBP-CorV, in terms of both safety and efficacy, for use in people with co-morbidities or health states that put them at higher risk for severe COVID-19.

Meanwhile, vaccine access could improve further next week when the WHO considers CoronaVac, a vaccine made by Chinese drug developer Sinovac. Andrea Taylor, who analyses global data on vaccines at the Duke Global Health Institute, said the potential addition of two Chinese vaccines into the COVAX programme could “really change the landscape of what’s possible over the next few months,” adding that given “the situation right now…for low- and lower-middle-income countries…any doses we can get out are worth mobilising.”

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