November 10, 20 - 11:46 am - LABS

Sinovac’s COVID-19 vaccine trial suspended in Brazil due to severe adverse event

Brazilian health regulator (Anvisa, in Portuguese) has suspended a clinical trial for the COVID-19 vaccine developed by Chinese pharmaceutical company Sinovac in partnership with the government of the state of São Paulo after a “severe adverse event.”

According to the Butantan Institute, the laboratory under trial organization, the severe adverse event occurred in a volunteer who participated in the research. However, it was absolutely unrelated to the vaccine, they said in a press conference earlier this Tuesday.

A source familiar with the matter told Reuters the incident that led to the suspension was a suicide. The state government of Sao Paulo, where the trial is being run, later confirmed that a death of a volunteer had been registered as a suicide and was being investigated further.

Sinovac’ has been a subject of controversy between President Jair Bolsonaro and São Paulo governor João Doria. The suspension delighted Bolsonaro, who has criticized it for lacking credibility amid growing geopolitical tensions with China and the US.

The health regulator, Anvisa, said on Monday the event occurred on Oct. 29 but did not specify if it took place in Brazil or in another country. It also did not give an indication of how long the suspension might last, reported Reuters.

The setback to Sinovac’s efforts contrasts with good news from Pfizer which said its experimental COVID-19 vaccine is more than 90% effective based on initial trial results.

Unlike other vaccines, such as Sinovac’s Coronavac and Sputnik V, there is no formal deal for the production or purchase of Pfizer’s vaccine in Brazil, either with institutions or governments. Without it, it would not be available through SUS (Brazilian public health system), only in private networks.

(Updated at 4:17 pm)