The Anmat approved the dengue vaccine: when it arrives and how many doses will be applied

by time news

2023-04-27 05:43:00

The National Administration of Medicines, Food and Medical Technology (ANMAT) authorized this Wednesday, April 26, the use of the dengue vaccine developed by the Japanese laboratory Takeda for all people older than 4 years, whether or not they previously had the disease. will be administered two doses which must be applied in a three month interval.

The Japanese laboratory will immediately implement the protocols for start of the production process for the shipment of a batch which would arrive, according to official estimates, during the spring.

It’s about the TAK-003 vaccinewhich is indicated for all people over 4 years of age, regardless of whether or not they have contracted the disease.

The Japanese reference laboratory will begin its production process in order to be able to send the first batch to the country, reported the Ministry of Health.

“Vaccination does not fulfill the function of blocking against the current outbreak of dengue and recommended continuing with vector prevention and control measures“It was officially stated.

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Characteristics of the TAK-003 vaccine

Called TAK-003, the vaccine is based on the dengue 2 virus, to which DNA from the other three serotypes is added to protect against any of the four types of dengue.

Its form of administration are two doses which must be applied in a three month interval.

TAK-003, also known as Qdenga, received its first approval in August 2022 in Indonesia and subsequently in the European Union in December 2022.

Foto: Shutterstock

This was followed by the United Kingdom in January 2023 and has also recently been approved by the Brazilian National Health Surveillance Agency (ANVISA). Its use is contemplated for endemic areas.

“In a clinical study that included more than 20 thousand participants, for 4.5 years, the vaccine demonstrated reduce a 84% hospitalizations for dengue and 61% cases of symptomatic dengue”, reported in a press release from the Takeda laboratory.

Dengue
Dengue. Photo: Telam

After approval by ANMAT, the Japanese laboratory will establish the protocols for start of the production process for the shipment of a batch of it to our country.

When this happens, once this cycle is completed and always following quality and traceability standards, Argentina will be in a position to receive this shipment for its subsequent commercialization in national territory, the Ministry explained.

Authorities of the portfolio he directs Carla VizzottiMeanwhile, they held a meeting with specialists and experts to analyze the different vaccines approved against dengue, or in the process of being approved, as well as to study the possible implementation recommendations of a vaccine against this disease.

ANMAT approved a vaccine against dengue 20230426
Foto: Shutterstock

The meeting was attended by representatives of the Takeda laboratory, as well as the Butantan Institute of Brazil and the Sanofi-Pasteur laboratory, who presented an update on the phase III studies of its dengue vaccines.

They considered that, based on the data presented, no vaccine performs a blocking function against an outbreak of dengue like the one currently taking place in our country, therefore prevention tasks must be maintained.

Dengue: more than 67,000 cases and 48 deaths were registered, the highest number in the country’s history

Historical outbreak of dengue in the country

Until April 15, they were notified in the country 56,324 cases of dengueof which 51,637 acquired the infection in Argentina.

To date, the circulation of this virus has been identified in 15 jurisdictions corresponding to four regions: Central Region (Buenos Aires; Autonomous City of Buenos Aires; Córdoba; Entre Ríos; Santa Fe); NEA region (Corrientes; Formosa; Chaco); NOA region (Catamarca; Jujuy; La Rioja; Salta; Santiago del Estero; Tucumán) and the province of San Luis in the Cuyo region.

The cases registered up to now present a wide territorial distribution with a greater number of cases in the NOA and Central regions, predominantly the circulation of DEN-2 and, to a lesser extent, DEN-1. This is an important difference with respect to other years in which the DEN-1 predominated.

CA/ED

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