Johnson & Johnson interrupts COVID-19 vaccine studies

Anvisa has been informed of the interruption of tests

Published in 13/10/2020 - 14:30 By Pedro Peduzzi - Brasília

Brazil’s national sanitary watchdog Anvisa has received an official communication from Johnson & Johnson announcing it has temporarily interrupted clinical studies investigating the safety and efficiency of its vaccine against COVID-19 (VAC31518COV3001).

“The study has been temporarily interrupted due to a serious adverse effect reported on a volunteer overseas,” the note reads. The company, however, provided no further details, as the volunteer’s health state is classified.

The study will remain halted until an investigation is conducted by the Independent Safety Committee, as part of the procedures of good clinical practice, Anvisa declared.

“In Brazil, the inclusion of the first volunteer in the study took place on October 9, and new inclusions may only be implemented upon authorization by Anvisa, which will continue assessing investigation data to make a decision on whether to resume or permanently interrupt the studies, based on the safety data and a risk–benefit analysis,” Anvisa’s statement reads.

Also in a note, Johnson & Johnson said it has observed its guidelines and that the participant’s disease “is being analyzed and assessed by Independent Council for Monitoring Safety Data ENSEMBLE (DSMB), as well as by our clinical doctors and internal safety doctors.”

Translation: Fabrício Ferreira -  Edition: Lílian Beraldo

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