Brazil health regulator authorizes clinical trials of Sanofi’s Covid-19 vaccine

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) on Tuesday, July 6, authorized clinical trials of Sanofi Pasteur’s Covid-19 vaccine in Brazil. Trials will gather 150 volunteers over 18 years of age and will be conducted in the states of Bahia, Minas Gerais, Mato Grosso do Sul, and Rio de Janeiro.

The trial comprises phases 1 and 2 and will test three different dosages of the vaccine to determine the ideal dose before proceeding to a phase 3 trial, the last stage. It will entail two doses administered 21 days apart. A separate group of volunteers will receive an inactive substance to compare results (placebo group).

ANVISA did not announce the date for the trial to begin.

Sanofi’s candidate uses messenger RNA technology encapsulated inside a lipid nanoarticulation (LNP). Moderna and Pfizer’s vaccines use the same technology.

Globally, the vaccine will also be tested in the United States, Honduras, and Australia. The clinical trial is being sponsored by Sanofi; if approved, the vaccine will be manufactured by Translate Bio in the United States, Evonik Canada Inc. in Canada, and Sanofi itself, based in France and the United States.

Vaccine trials in Brazil

This is the 8th Covid-19 vaccine trial authorized by ANVISA. The previously approved trials were as follows:

June 2, 2020: vaccine developed by the University of Oxford and AstraZeneca (completed/being administered in Brazil)
July 3, 2020: vaccine from Sinovac Research & Development Co Ltd, in partnership with the Butantan Institute (completed/being administered in Brazil)
July 21, 2020: vaccine from Pfizer/BioNTech (completed/being administered in Brazil)
August 18, 2020: Janssen-Cilag/Johnson vaccine (completed/being administered in Brazil)
April 8, 2021: Medicago/GSK vaccine (phase 3)
April 16, 2021: Sichuan Clover Biopharmaceuticals’ SCB-2019 vaccine (phase 3)
May 13, 2021: Covaxin (Phase 3)

The Pfizer/BioNTech and AstraZeneca/Oxford vaccines have been granted definitive registration for use by ANVISA. The CoronaVac and Johnson/Janssen vaccines have been authorized for emergency use.

Currently, the National Immunization Plan (PNI) uses 4 vaccines in the Brazilian population: CoronaVac, Oxford, Pfizer and Johnson.

Source: G1