Brazil stops COVID-19 vaccine after ‘serious adverse event’

Brazil has halted trials of a COVID-19 vaccine developed in China after a volunteer suffered a “serious adverse event,” according to a report.

The suspension of CoronaVac from Chinese drug maker Sinovac Biotech was reported in a memo from Brazil’s National Health Surveillance Agency, which said trials would be suspended following the Oct. 29 incident, a reported CNN.

“The study being interrupted, no new volunteers can be vaccinated,” read the note, published by CNN Brasil on Monday evening.

Details and other details were not disclosed in the memo due to health privacy concerns, the outlet reported.

However, Reuters, citing a source familiar with the matter, said the incident which led to the stay of the trial was suicide.

Health officials in Brazil now want to take the time to assess the data and assess the risks before moving forward, although organizers of the trial have insisted the death didn’t had nothing to do with the vaccine.

“We had an external event which led to the regulator’s notification,” Jean Gorinchteyn, health secretary for the state of Sao Paulo, where the trials are being carried out, said on Tuesday.

“This vaccine is safe.”

Sinovac Biotech began its Phase 3 trials in July – a crucial step in the process of obtaining regulatory approval – with plans to recruit 130,000 volunteers, CNN said.

The suspension marks a serious setback for one of China’s most promising vaccine candidates, especially after Pfizer announced Monday of its own COVID-19 vaccine which was found to be over 90% effective.

Sinovac also insisted in a Tuesday statement that he was “confident in the safety of the vaccine.”

“We have contacted our Brazilian partner, the Butantan Institute, and the director of the institute believes the incident has nothing to do with the vaccine,” the company said.

“Sinovac will continue to communicate with the Brazilian side on this matter. Work related to our clinical research in Brazil will continue to be carried out in strict compliance with GCPs [good clinical practice] requirements. “