Brazilian health regulator Anvisa has authorized the resumption of a clinical trial of Johnson & Johnson‘s experimental COVID-19 vaccine, according to a statement from the government agency on Tuesday.
The J&J vaccine is one of four being tested in Brazil, which has the world’s third-worst outbreak behind the United States and India, and the second-highest COVID-19 death toll.
J&J’s trial in Brazil had been suspended since Oct. 12, so a safety panel could evaluate an unexplained illness of a participant in its planned 60,000-person Phase III study. Testing of the vaccine in the United States resumed last month.
Anvisa said when the trial was interrupted, 12 volunteers in Brazil, all from Rio de Janeiro, had either received a dose of the vaccine or a placebo.
The study in the South American country is being conducted in 11 states, and is expected to involve up to 7,560 people over the age of 18, Anvisa said.