Health regulator authorizes Phase 3 clinical trials in Brazil of new Covid-19 vaccine

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (Anvisa), on Thursday, April 8, authorized Phase 3 trials in Brazil of one more vaccine against Covid-19. The immunizer is being developed by the biopharmaceutical Medicago R&D Inc. from Canada and the British pharmaceutical giant GlaxoSmithKline (GSK).

The clinical trials to be conducted in Brazil are last stage Phase 3 and will involve 3,500 volunteers over the age of 18.

Participants will receive a single dose of the vaccine or a placebo (inactive substance), to serve as a control group. The determination of who receives the vaccine or the placebo will be made randomly, and will be “observer-blind”, meaning neither the volunteers nor the researchers will know which people received which substance.

Anvisa did not advise the date for the beginning of the tests, which also depend on the approval of the National Research Ethics Council (Conep) – the body of the Ministry of Health responsible for the ethical evaluation of clinical research – and the organization of researchers to recruit volunteers.

According to Anvisa, the potential Medicago/GSK vaccine uses coronavirus-like particle technology and is applied in two doses, with a 21-day interval between them.

There is no information on whether the Phase 3 trials will be restricted to healthcare professionals.

Besides Brazil, Phase 3  testing of the vaccine will occur in Canada, the United States, Latin America, the United Kingdom, and Europe. The study is expected to involve 30,000 volunteers.

Vaccines tested in Brazil

This is the fifth vaccine trial against the novel coronavirus authorized by Anvisa. The previously approved studies were:

June 2, 2020: vaccine developed by the University of Oxford and AstraZeneca;
July 3, 2020: vaccine from Sinovac Research & Development Co Ltd, in partnership with Instituto Butantan;
July 21, 2020: vaccine from Pfizer/BioNTech;
August 18, 2020: vaccine from Janssen-Cilag/Johnson.

The Pfizer/BioNTech and AstraZeneca/Oxford vaccines have been granted definitive registrations for use at Anvisa. CoronaVac and the Johnson/Janssen vaccine, on the other hand, have been authorized only for emergency use.

Currently, the National Immunization Plan (PNI) uses two vaccines in the Brazilian population: CoronaVac and Oxford/AstraZeneca.

Source: G1