Anvisa analyzes approval of highly effective dengue vaccine

A dengue vaccine produced by pharmaceutical company Takeda is under analysis by the National Health Surveillance Agency, for possible approval in Brazil. The immunizer is known to have the TAK-003 Qdenga. According to the company, the initial request for release was made in April 2021, but Anvisa asked for clarification to continue the analysis.

The pharmaceutical responded to one of these requests in December 2022, which made the processor work. A meeting between the agency, representatives of Takeda and dengue specialists in Brazil should take place this Tuesday (10), however, there is still no forecast of when the agency’s evaluation will come out.

The vaccine is already used in the European Union and Indonesia. It was manufactured from serotype 2 of the virus, which causes dengue, but with the addition of genetic material from the other three serotypes. Thus, the immunizer has protection for all agents that cause the disease with immune responses in varying degrees for all four, according to the studies.

The immunizer is of the attenuated type, that is, when the pathogen is modified so as not to cause the disease, but still responds with immunity to the organism. The medicine is indicated for people between four and 50 years of age. (Source: Folha de S. Paulo)

Third phase of research

Phase three of the research is for children and adolescents who live in endemic areas for the disease. Brazil was part of the sample. After 54 months of application of the second dose, the vaccine is estimated to be around 61% effective. To avoid severe cases, the effectiveness was 84%.

Dengue in Brazil

^{Anvisa analyzes approval of highly effective dengue vaccine}

^{(Photo: Reproduction/Shutterstock/Diário do Nordeste)}

The disease is transmitted by the Aedes Aegypti mosquito. The virus is increasing in cases and deaths in Brazil. Only from probable cases there were more than 1 million by 2022. For deaths, the number was 1,016.

Dengue vaccine produced by Butantan

A dengue vaccine was also developed by the Butantan Institute, which obtained 79.6% efficacy in clinical trials. The institute reported that it monitored a group of 16,000 participants for two years and did not record any serious cases of the disease among those who received the vaccine.

The clinical study phase of the vaccine against the disease began in 2016, when the vaccine was administered to 10,000 volunteers between 2 and 59 years of age, with 6,000 receiving a placebo. The incidence of symptomatic dengue among participants was evaluated from 28 days after immunization. The survey will continue monitoring for five years and is expected to end only in 2024.

The effectiveness of the vaccine was even higher among people who had contracted the disease before the study, reaching 89.2%. Among people who never had the disease, the effectiveness reached 73.5%.

During the research period, only dengue types 1 and 2 were circulating in Brazil, but the vaccine covers all four types of the virus. The effectiveness to prevent infection by these varieties reached 89.5% and 69.6%, respectively.

vaccine effects

Among the more than 10,000 people immunized, only three people had adverse effects considered serious within 21 days of applying the vaccine, but all recovered fully.

More than 10 years of research

Butantan’s vaccine against dengue uses technology from the US National Institute of Health, licensed in 2009. The first phase of the clinical trials was carried out in the United States, between 2010 and 2012, and the second part of the research, in Brazil, between 2013 and 2015. The tests proved that the vaccine is safe and protects against the four serotypes of the virus, which was one of the greatest difficulties for the development of an immunizer against the disease, although there is still a little more than a year left for the closure of the study. (Source: Brazil Agency)

Featured Photo:Anvisa analyzes the approval of a highly effective dengue vaccine/Photo: Reproduction/Rovena Rosa/Agência Brasil