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Johnson & Johnson announced on Wednesday (23) that it will begin phase 3 testing of its candidate vaccine for Covid-19, the disease caused by the new coronavirus (Sars-CoV-2). This test step, which is the last, It must include up to 60 thousand volunteers in 8 countries, including Brazil, and it will accept participants over 60 years of age and with pre-existing diseases. The minimum age to participate is 18 years old.
Anvisa (National Health Surveillance Agency) had already authorized, last month, immunization tests in the country. The forecast is that there will be 7 thousand volunteers in 7 states (Bahia, Minas Gerais, Paraná, Rio de Janeiro, Rio Grande do Norte, Rio Grande do Sul and São Paulo) and in the Federal District.
Johnson vaccine, whose official name is Ad26.COV2.S, was developed by the pharmaceutical company Janssen Pharmaceuticals, which belongs to the group, and it will be applied in a single dose to half of the volunteers. The other half will receive a placebo (inactive substance) and will serve as a control group.
The determination of who will receive the vaccine or the placebo will be done randomly (randomized) and neither the volunteers nor the researchers will know which people received which substance (this type of study is called “double blind”).
If the efficacy and safety of the vaccine is demonstrated, the expectation is that it will be available in early 2021 for emergency use, according to the company.
In phase 1 and phase 2 trials, which test the safety and efficacy of a vaccine, scientists try to identify serious adverse effects and whether the immunization was able to induce an immune response, that is, a response from the body’s defense system. Johnson’s vaccine demonstrated safety and induced an immune response in phases 1 and 2.
Vaccine tests typically have dozens (phase 1) or hundreds (phase 2) of volunteers and are done separately. Phase 3, on the other hand, typically has thousands of participants. In the pandemic, due to the urgency of finding a Covid-19 vaccine, several companies have taken more than one step at the same time.
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Before testing in humans, vaccines are tested in animals, usually mice and monkeys.
In addition to Brazil, Johnson’s vaccine is also expected to have phase 3 trials in Argentina, Chile, Colombia, Mexico, Peru, South Africa and the United States. The locations were chosen due to the high incidence of Covid-19. At the same time, there should also be a collaboration between Johnson and the UK in another separate phase 3 trial to explore a two-dose vaccine regimen.
