W.H.O. experts claim “very low confidence” in some Sinopharm vaccine data

RIO DE JANEIRO, BRAZIL – World Health Organization (W.H.O.) experts expressed “very low confidence” in data provided by Chinese state-owned drugmaker Sinopharm on its Covid-19 vaccine with respect to the risk of severe side effects in some patients, but overall confidence in its ability to prevent the disease, a document showed.

A W.H.O. spokesman said the document on Sinopharm’s vaccine, called BBIBP-CorV, is “one of many resources” upon which recommendations are made. A W.H.O. recommendation on the vaccine may be announced later this week.

In Beijing, Sinopharm was not immediately available for comment outside business hours.

The “evidence assessment” document was prepared by the W.H.O.’s Strategic Expert Advisory Group (SAGE) to review the Sinopharm vaccine, currently authorized in 45 countries and jurisdictions for use in adults and with 65 million doses administered. The experts review evidence and make recommendations on guidelines and dosages associated with a vaccine.

The vaccine’s efficacy in late-stage clinical trials in several countries stood at 78.1% after two doses, the paper said -a slight decrease from the 79.34% previously announced in China.

“We are very confident that two doses of BBIBP-CorV are effective in preventing Covid-19 confirmed by PCR (examination) in adults (aged 18-59 years of age),” the paper said.

But the text added: “A safety analysis among participants with comorbidities (was) limited by the low number of participants with comorbidities (other than obesity) in the late-stage trial.”

Among the “evidence gaps,” the text quoted data on protection against severe forms of the disease, duration of protection, safety in use in pregnant women and older adults, and identification and evaluation of rare adverse events through post-authorization safety monitoring.

“We have very low confidence in the quality of the evidence that the risk of rare adverse events after one or two doses of BBIBP-CorV in older adults, or in individuals with comorbidities or health conditions that increase the risk of severe Covid-19, is low.”

The SAGE analysis was prepared as a W.H.O. technical advisory group reviews the vaccine for emergency use clearance, which would not only pave the way for its inclusion in the Covax global vaccine sharing platform, but would provide a crucial international endorsement for a vaccine developed in China.

Source: Moneytimes