For Brazilian regulatory agency, benefits of the immunizer outweigh the rare risks of blood clotting
THE National Health Surveillance Agency (Anvisa) stated this Friday, 6th, that he maintains the indication for the use of the Janssen Against the Covid-19 in Brazil. The immunizer received restrictions from the Food and Drug Administration (FDA) for use in U.S on Thursday, 5, due to the very low risk of a syndrome that causes the blood to clot. In the US, doses should only be given if there are no other vaccines available against the coronavirus or if the individual is less interested in receiving one of the others.
“To date, the benefits outweigh the risks for all vaccines approved by Anvisa. Thus, at this time, the Agency does not identify the need for regulatory action regarding the Janssen or any other vaccine,” the agency said. Anvisa also pointed out that the risk of thrombosis syndrome with thrombocytopenia (which involves blood clots) is very rare and prescribed in the package insert; and that the cases usually occur after the application of the first dose. In a meeting with the FDA, representatives of the Brazilian agency were informed that there is no news regarding the safety of the immunizer. Finally, Anvisa stressed that the decision on prioritizing an immunizing agent is up to the Ministry of Health and that it maintains a continuous assessment of the benefit-risk ratio. The Ministry of Health did not respond to questions sent by the Young pan.