Butantan Institute requests authorization from Anvisa to begin human vaccine testing

A request made by the Butantan Institute is submitted to the National Health Surveillance Agency (ANVISA) to begin clinical trials on humans of the H1N1 vaccine in order to be prepared for a possible future avian flu pandemic.

As this is a virus that is already present among animals, the Institute aims to have a dose prepared in case the virus spreads to humans, as it can cause serious infections in humans and consequently spread a new pandemic.

Prepared for a possible pandemic

This is not a vaccine for commercialization, but rather to have a ready stock in case of a possible pandemic that the Ministry of Health requests if necessary. In other words, having a vaccine that produces antibodies and also with a tested platform means strategic preparation by the Institute. In a statement, the infectologist and director of the Institute, Esper Georges Kallás, explains: “Not only are we working on this vaccine candidate, we are also developing a technological path that can be followed if the virus changes”.

Clinical trials on animals completed

In 2023, the Institute began developing different doses of avian flu strains, due to several cases that were emerging, with more and more wild animals, including mammals. With this, clinical tests on animals have already been completed, and researchers want to begin testing on humans, with the H5N8 vaccine, requested by ANVISA.

_{Vaccine (Photo: reproduction/Getty Images Embed/FG Trade)}

In March, ANVISA approved a resolution allowing the registration of vaccines against influenza strains, for cases of public health emergencies, which shows that it can happen and that other countries have been adopting the same strategic measure.

It is worth remembering that they will be used if approved for cases of need and will not be used immediately. And their distribution will only occur through the Ministry of Health.

The request for human testing has a 90-day period for analysis by ANVISA.

Featured Photo: Woman with flu (reproduction/Getty Images Embed/Cecilie_Arcurs)