RIO DE JANEIRO, BRAZIL – The National Technical Committee on Biosafety – CTNBio has just approved the clinical protocol, submitted by Janssen, Johnson & Johnson’s pharmaceutical arm, for conducting the phase 3 clinical trial (the last stage of a research) of the vaccine against the novel coronavirus in Brazil.
The third phase of clinical trials is expected to begin in September. The authorization request for the trial will also be analyzed by other bodies, such as ANVISA (National Health REgulatory Agency) and CONEP (National Research Ethics Committee).
Ad26.COV2.S, the name given to the vaccine developed by Johnson, is considered one of the most promising against the disease and is part of the American government’s incentive program. The last stage of the vaccine’s testing is expected to include 60,000 healthy volunteers between the ages of 18 and 60.
According to data on the study registered on clinicaltrials.org, there will be 178 study centers located in nine countries: the United States, Brazil, Chile, Colombia, Mexico, Peru, the Philippines, South Africa and Ukraine. In Brazil, there are 22 institutions involved, located in São Paulo, São José do Rio Preto, Salvador, Rio de Janeiro, Porto Alegre, Natal, Curitiba, Campinas, Brasília, Belo Horizonte and Barretos.
“The decision on which countries will be involved in the study considers the current prevalence of the disease, population demographics and regulatory authorities’ requirements, to ensure that the study can be conducted appropriately and produce relevant data on vaccine safety and efficacy,” says the laboratory. Brazil’s rolling daily average of cases and deaths now stands at 43,157.1 and 969.1, respectively.
Source: Veja