Dengue fever vaccine recommended for approval in Europe

Dengue fever has been a problem in Brazil for decades, but it’s not just Brazilians who suffer from the disease: yearly Around four billion people worldwide are at risk of contracting the disease..

In mid-October, a new dengue vaccine developed by pharmaceutical company Takeda received a recommendation for approval from the European Medicines Agency (EMA) committee, and it could soon lead to market launch in Europe and other continents. So far, the immunizer, identified as QDENGA or TAK-003, has only been approved for use in Indonesia since August this year.

According to Takeda, more than 28,000 children and adults participated in the vaccine study. The data showed that the vaccine prevented 84% of hospitalizations and 61% of symptomatic cases. The company says no significant security risks have been identified so far.

The vaccine promises to prevent disease from any serotype in people aged four years and older. The recommendation of the Committee for Medicines for Human Use (CHMP) applies to Europe and countries participating in the EU-M4all procedure where dengue fever is endemic – Brazil is part of the list.

In order for the vaccine to be distributed, it still needs to be approved by the EMA Marketing Authorization in Europe, in addition to the necessary regulations in other EU-M4all participating countries. TAK-003 uses a live attenuated dengue serotype 2 virus, but provides genetic information for all four dengue viruses.

“We are one step closer to approving a dengue vaccine that could benefit millions of people exposed to the disease worldwide. This is an important moment for the global health community, European countries and dengue endemic countries participating in the EU-M4all procedure,” he said.

dengue fever vaccine in Brazil

Worldwide, approximately 500,000 hospitalizations and 390 dengue infections occur each year, with severe dengue responsible for 5% of reported cases in Latin America and Asia.

Brazil experienced a disease outbreak in 2022, which represents a sudden drop in numbers compared to previous years.

There is currently a vaccine against dengue fever called Dengvaxia, which is available through the private health network.

In a sent note, Takeda says: TecMundo In 2021, it applied to Anvisa (National Health Surveillance Agency) for TAK-003 approval.

“Recognizing that the estimation of the approval period is solely up to the regulatory authority, Takeda is committed to promptly responding to any questions that arise in order to ensure that the population has access to the vaccine as quickly as possible,” he says. company note.