Brazil’s national sanitary watchdog Anvisa authorized Jansen-Cilag, the pharmaceutical unit of Johnson & Johnson to conduct clinical trials for the development of a vaccine against COVID-19. The global study is expected to include 60 thousand volunteers, 7 thousand of them in Brazil, distributed across the states of São Paulo, Rio Grande do Sul, Rio de Janeiro, Paraná, Minas Gerais, Bahia, and Rio Grande do Norte.
In a note released today (Aug. 18), Anvisa reported that the data supporting the permit included non-clinical studies with the vaccine and both non-clinical and clinical data from other vaccines based on the same modeling.
The Jansen-Cilag studies started in the US and Belgium in July. The clinical trials, the agency declared, will be conducted in stages and each stage will only start if the results available are satisfactory.
This is the fifth study on a vaccine against the novel coronavirus authorize by Anvisa in Brazil. On June 2, the agency authorized a clinical trial with the vaccine developed by AstraZeneca and the Oxford University, in the UK; with the vaccine developed by China’s Sinovac Biotech in partnership with the Butantan Institute, on July 3; and the vaccines developed by Germany’s BioNTech and US Wyeth/Pfizer, on July 21.
Jansen-Cilag’s potential vaccine, dubbed Ad26.COV2.S, is made up of a non-replicating recombinant vector of 26 (Ad26)-type adenovirus, built to decode protein S (Spike) of the virus Sars-CoV-2 (the new coronavirus).
The approved clinical trial is a randomized, double-blind phase 3 study, controlled by placebo, aimed at assessing the effectiveness and safety of Ad26.COV2.S in preventing COVID-19 in adults aged 18 and older. Each participant will be given a single shot of the vaccine or placebo. The recruiting of volunteers is the responsibility of the centers conducting the research.
