Anvisa authorizes research with a tetravalent influenza vaccine. In the clinical trial, participants between 6 and 35 months will be included.| Photo: Marcello Casal JrAgência Brasil

The National Health Surveillance Agency (Anvisa) published, this Thursday (16), the authorization for the start of the Phase III clinical trial of the tetravalent influenza vaccine (fragmented and inactivated) QIV-IB, developed by the Butantan Institute, in São Paulo .

The study intends to evaluate the immunogenicity and safety of the vaccine in infants and children aged six to 35 months. According to the agency, the difference between the clinical trial approved today (FLQ-02-IB) and the previous one (FLQ-01-IB), in February, is the age of the participants. While in the first the participants would have to be three years old or older, in the clinical trial approved now (FLQ-02-IB) participants between six and 35 months will be included, in addition to the vaccine dose adjusted for age.

The production process of the tetravalent vaccine is similar to that of the trivalent vaccine (fragmented and inactivated) by the Butantan Institute (TIV-IB), which is already used in national influenza vaccination campaigns by the National Immunization Program (PNI)/Ministry of Health.

“In this way, it is expected to obtain a tetravalent influenza vaccine analogous to the trivalent one, but with additional protection against a second B strain, determined seasonally by the World Health Organization (WHO). The addition of the second B strain of influenza (fourth strain in the vaccine) occurred in the transition from the bivalent seasonal influenza vaccine to the trivalent one, after the H1N1 influenza pandemic in 2009”, explained Anvisa. With information from Agência Brasil.