- See what is known about a break in Johnson’s Covid-19 vaccine testing
In a statement, the company said that the independent board of the Safety Data Monitoring Committee recommended resumption of activities because it found no link between an adverse effect on one of the volunteers with the vaccine.
“After a complete evaluation of a serious medical event presented by a study participant, no clear cause could be established. Several factors may have caused the event. Based on the information collected so far and the contributions of independent experts, the company found no evidence that the candidate vaccine caused the complication ”, says the note.
The vaccine is also being tested in Brazil. Regarding the resumption of studies in the country, the institution said that awaits the release of the National Health Surveillance Agency (Anvisa).
Anvisa informed the G1 what is analyzing the data to assess the possibility of resuming studies.
Johnson and Johnson suspend testing of their Covid-19 vaccine
Phase 3 in Brazil and preliminary results
Immunization, whose official name is Ad26.COV2.S, was developed by the pharmaceutical company Janssen Pharmaceuticals, which belongs to the J&J group. Immunization was the fourth to obtain authorization for phase 3 tests in Brazil, in August. In September, the company announced that it would start the third stage worldwide, with 60,000 volunteers. In Brazil, according to Anvisa, there are 7 thousand participants.
On September 29, preliminary and partial results indicated that the vaccine was safe and induced an immune response even after a single application.
The results were for a part of the participants in phases 1 and 2, which were conducted jointly.