Vaccine against dengue is under analysis by Anvisa

A dengue vaccine produced by pharmaceutical company Takeda is under analysis by Anvisa (National Health Surveillance Agency) for possible approval in Brazil. The vaccine is known as TAK-003 or Qdenga.

According to the company, the initial request for release was made in April 2021, but the agency asked for clarification to continue the analysis. The pharmaceutical responded to one of these requests in December last year, which made the process go.

A meeting between Anvisa, representatives of Takeda and dengue specialists in Brazil should take place this Tuesday (10). There is still no prediction of when the agency’s assessment will be completed.

The vaccine received authorization from the EMA (European Medicines Agency) in December 2022 to be used in the European Union. Indonesia has also authorized the drug.

The immunizer is of the attenuated type, that is, when the pathogen is modified so as not to cause the disease, but still causes the body’s immune response. He is indicated for people from 4 to 50 years old.

The vaccine was manufactured from serotype 2 of the virus that causes dengue, but with the addition of genetic material from the other three serotypes. Thus, the immunizer provides protection for all agents that cause the disease, with immune responses in varying degrees for all four, according to clinical studies.

One of these surveys is phase 3 with children and adolescents living in endemic areas for the disease — Brazil was part of the sample. After 54 months of application of the second dose, the vaccine had an estimated effectiveness of around 61%. To avoid severe cases, the effectiveness was around 84%.

transmitted by mosquito aedes aegypti, dengue is experiencing an increase in cases and deaths in Brazil. Only from probable cases there were 1,450,270 by the end of 2022. For deaths, the numbers were 1,016.

Another dengue vaccine, the one produced by Sanofi, exists and was even authorized for use in Brazil, but it stopped being used after research showed that it was associated with serious adverse effects in children with no history of previous infection.

There is still an immunizer under study by the Butantan Institute. The vaccine is a single dose and uses the four attenuated viral strains in its composition. Called Butantan-DV, it is an analogous version of the one developed by the US National Institute of Health. Pharmaceutical MSD is also part of the immunizer development project.

According to a survey, Butantan measured the overall effectiveness of 79% of the vaccine, but also the differences seen between those who had already had the infection and others who had never had it. In those with a history of dengue, efficacy was around 89%. For the other portion of participants without a record of the disease, the protection provided by the vaccine was lower: 73%.