Brazil’s National Health Surveillance Agency reported a serious adverse event (SAE) on Oct. 29 in a study participant involved in the phase three trial of the Sinovac vaccine, leading to a decision to suspend the trial in the country. Pauses in clinical trials are common and were also seen previously in the phase three trials for AstraZeneca’s and Johnson & Johnson’s candidate vaccines.

In the latest development, Sinovac on Tuesday released a clarification of interruption in the phase three trial.

“We have noticed some media reports. After communicating with the Brazilian partner, the Butantan Institute, we’ve learned the head of the Butantan Institute believes that the SAE was not related to the vaccine. 

“Sinovac will continue to communicate with Brazil on this matter. The clinical study in Brazil is strictly carried out in accordance with GCP [good clinical practice] requirements and we are confident in the safety of the vaccine,” said Sinovac on its official website, sinovac.com.

Padjadjaran University’s (Unpad) team spokesperson Rodman Tarigan said the trial in Indonesia, which involves more than 1,600 volunteers, had yet to encounter an SAE.

Meanwhile, team leader Kusnandi said that all volunteers had received their first and second doses of the would-be vaccine.

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