J&J resumes COVID-19 vaccine trial in BrazilNovember 5, 2020 0 By FM
The Brazilian Health Surveillance Agency Anvisa has given nod to resume the clinical trial of Johnson & Johnson’s (J&J) experimental COVID-19 vaccine in the country.
The trial was put on hold in October due to unexplained illness of a participant that was investigated by a safety panel to study the reasons.
Anvisa had authorised the J&J vaccine to be tested on about 7,560 adult volunteers in 11 states in Brazil. Upon trial interruption, all 12 volunteers from Rio de Janeiro, Brazil had either received a dose of the vaccine or a placebo, Reuters reported.
“After evaluating the data of this adverse event, the information from the Independent Safety Committee and data from the US regulatory authority (FDA), Anvisa concluded that the benefit-risk ratio remains favourable and that the study can be retaken.” said the agency in a statement.
The agency added that researchers would adopt preventive measures in study protocols if any severe reaction takes place in the Brazilian volunteers.
The J&J vaccine is one of the four shots being trialled in the country, which currently has the second-highest COVID-19 death toll. The country also has the world’s third-worst outbreak.
Last month, J&J resumed the trial in the US after a temporary pause.