As the vaccine spreads from Brazil to Indonesia, “qualitative” data is required on the harmful effects of the vaccine, the expert group says.
WHO experts have concluded that the COVID-19 vaccine produced by the Chinese company Sinovac Biotech is effective in preventing COVID-19 in adults under the age of 60, but there is a lack of some good data on the risks of serious adverse effects.
Independent experts at the World Health Organization’s (SAGE) Strategic Expert Group (SAGE) reviewed Sinovac’s CoronaVac dose from Phase 3 clinical trials in China, Brazil, Indonesia, Turkey and Chile.
The assessment came shortly after WHO’s SAGE experts announced “very low confidence” in the data provided by the Chinese state-owned pharmaceutical company Sinopharm on its COVID-19 vaccine regarding the risk of serious side effects in some patients but public confidence in its ability. On prevention. The disease, according to a document seen by Reuters news agency, which reported the news on Wednesday.
SAGE experts said the Sinovac vaccine is licensed in 32 countries and jurisdictions, with 260 million doses distributed.
“We are completely confident that two doses of CoronaVac are effective in preventing confirmed COVID19 PCR in adults (18-59 years),” SAGE said in an evaluation published on the WHO website.
He noted evidence gaps in safety during pregnancy and in clinical safety and protection in the elderly, and those with underlying disease, and the assessment of rare adverse events that were discovered through post-authorization safety monitoring.
Experts said they had a “moderate level of confidence” that the risk of serious adverse effects was low in people aged 59 or younger, but had a “low level of confidence” in the quality of evidence that this risk was also low for adults over 60.
They added: “We have low confidence in the quality of evidence that the risk of serious adverse events in individuals with comorbidities or health conditions increases the risk of severe COVID-19 after one or two doses of CoronaVac is low.”
A separate group of WHO technical experts was reviewing the Sinovac dose on Wednesday looking for a list of potential emergency uses for the WHO – which will not only pave the way for its use in the global COVAX vaccine sharing platform, but also provide critical international support for a vaccine developed in China.