When will the dengue vaccine from the Japanese laboratory Takeda be available in Argentina

When will the dengue vaccine from the Japanese laboratory Takeda be available in Argentina

If something synthesizes the firepower that has an endemic disease For a territory – that is, an evil that habitually and recurrently affects a region, area or country – it is the dengue fever.

The Argentina lives today the worst dengue epidemic with 129,595 registered cases and 65 deaths so far in 2023, according to the National Epidemiological Bulletin, week 30. Although the actual number of infected by the disease transmitted by the mosquito Aedes aegypti, could exceed 300,000, since many cases occur without showing symptoms or being registered in the system.

On April 26 of this year, the National Administration of Drugs, Food and Medical Technology (ANMAT) approved the use of the quadrivalent dengue vaccine, developed by the Japanese laboratory Takeda. This vaccine, also known as Qdenga, will be intended for people over 4 years of age, regardless of whether or not they have had the disease before.

According to Infobae, the Takeda laboratory confirmed that the dengue vaccine will be available for use in the spring. The Japanese laboratory began the production process months ago and is working to shorten production and distribution times.

In addition, dengue according to infectious disease experts broke with seasonality and with the most classic endemic areas : it is no longer a disease that is concentrated in the summer period of high temperatures, but transmissibility can survive throughout the year. Something that is gradually pushed by the effects of climate change and its “shelter” to more viruses, bacteria, fungi and the durability of zoonotic diseases – which are transmitted from animals to humans.

Currently, cases of dengue are detected in cities throughout the country. According to official information from the Ministry of Health of the Nation, the Classic Argentine endemic areas of dengue are Jujuy, Salta, Tucumán, Santiago del Estero, Corrientes, Chaco and Catamarca.

The formula Immunizer developed by the Japanese laboratory represents a radical change in the therapeutic approach to dengue, especially in the prevention of severe conditions.

Dengue is a flu-like viral illness, usually mild, but can develop deadly complications. There are no antivirals or specific treatments, and it is estimated that between 20,000 and 25,000 people, mainly children, die each year from the virus.

“The arrival of a new vaccine always opens a hope of preventing a disease and, fundamentally, of being able to prevent the most serious impact of it, especially those cases that may require hospitalization and put life at risk,” said the doctor. Pablo Bonvehí, Head of Infectology at the CEMIC University Hospital, when the approval of the ANMAT was known.

“It is important to mention that this new vaccine will be a fundamental tool in the prevention of dengue along with the other measures that we already know, such as the Actions aimed at preventing the mosquito from finding suitable breeding environments and those that serve to protect people from the bites of the same, “he said to Infobae the infectious disease doctor Bonvehí.

The complete scheme of the quadrivalent vaccine Qdenga Includes two doses of 0,5 ml, separated by an interval of three months, without the need for confirmatory blood tests prior to application.

The vaccine called TAK-003 is based on the Live attenuated dengue virus 2, with added DNA from the other three serotypes, offering protection against all four serotypes of the disease.

As detailed Infobae, the vaccine demonstrated an overall efficacy of 80.2% in preventing symptomatic dengue cases within 12 months of application based on clinical trials. In addition, Qdenga met a key endpoint by preventing 90.4% of hospitalizations 18 months after vaccination.

The Qdenga vaccine received its first approval in August 2022 in Indonesia, followed by the European Union, the United Kingdom and Brazil.

The robuThis clinical study called TIDES of which the Qdenga vaccine resulted included more than 20 thousand healthy participants from endemic areas, with a follow-up for 4.5 years, where the vaccine was shown to reduce hospitalizations for dengue by 84% and cases of symptomatic dengue by 61%; with a very good safety profile.

The full clinical program comprised 19 studies including those already completed and those still ongoing and represents the largest survey ever conducted by Takeda for a pharmaceutical product in its two-and-a-half-century history.

This vaccine is based on live attenuated virus, developed from dengue serotype 2, which provides the genetic ‘backbone’ for all four serotypes and is designed to protect against any of these. As for storage, it requires storage in a refrigerator at a temperature of between 2 and 8 ° Celsius

In this regard, infectologist Analía Urueña, director of the Center for Studies for the Prevention and Control of Communicable Diseases of the Isalud University “The main transmitting agent of the disease is the Aedes aegypti mosquito,” said Dr. Analía Urueña, Director of the Center for Studies for the Prevention and Control of Communicable Diseases of the Isalud University. “The infection is caused by any of the four dengue virus serotypes, each of which can produce dengue fever or severe dengue. Infection with one of them does not confer protection against the remaining serotypes. This vaccine is quadrivalent and has been shown to generate a response against all four serotypes, he explained.

The vaccine is contraindicated in pregnant women, lactating women and immunosuppressed individuals. The most common side effects include pain and redness at the injection site, headache, muscle pain, malaise and weakness.

From the Takeda laboratory they pointed out that “at present, near the half the world lives under the threat of dengue, which is estimated to cause 390 million infections and around 20,000 deaths worldwide each year,” referring to those expressed by the World Health Organization (WHO) and the Pan American Health Organization (PAHO).

Despite the approval of the vaccine, health authorities and experts insist on the importance of continuing with vector prevention and control measures.

The Pan American Health Organization (PAHO) is holding talks with the Japanese pharmaceutical company Takeda. In that sense, the director of PAHO, Jarbas Barbosa, stressed that the data of the studies showed strong results, with a prevention of 61% of dengue infections and 85% of severe cases.

Barbosa said that while a World Health Organization (WHO) strategic group is likely to discuss the possibility of recommending the vaccine in the second half of 2023, PAHO has already begun initial discussions with Takeda on the price of doses. Brazil, Mexico and Colombia agree purchases through the PAHO fund, improvements could be obtained in lower prices.

The renowned infectologist of the Ricardo Gutiérrez Hospital, Ángela Gentile, recalled that “even when we have the vaccine for its prevention, in no way do we have to abandon the measures already known to avoid the proliferation of the mosquito vector, among which the most important are:

* the descacharrreo

* the elimination of containers with standing water

Measures to avoid bites, such as the use of repellent, ample clothing that protects arms and legs

*the installation of mosquito nets in homes

Dengue disease, although in some cases may be asymptomatic, when it expresses symptoms it presents with a acute and nonspecific febrile picture; It is so called because it is a picture of less than 7 days of duration, without respiratory symptoms. To these signs, severe headache, pain behind the eyes, muscle and joint pain and sometimes diarrhea or vomiting are usually added; A rash on the skin also occasionally appears.

“The evolution of the disease caused by dengue is related to factors of the person who is infected and the way he responds to the infection, the serotype that infects the person, and early consultation, said Eduardo López, head of the Department of Medicine at the Ricardo Gutiérrez Children’s Hospital. ” The efficacy figures shown by the clinical studyTakeda’s actions are very blunt,” added Dr. Lopez.

Another vaccine contemplated to prevent dengue is Dengvaxia, produced with weakened or attenuated live microbes. This formula was developed by the Sanofi Pasteur laboratory; it is a quadrivalent vaccine that was manufactured by means of a recombinant DNA technology and that It is applied with a schedule of 3 doses, at 0, 6 and 12 months.

In Argentina, Dengvaxia was approved by the regulatory ANMAT in 2017. According to the official document of the procedure, to which Infobae accessed, it was authorized “exclusively to prevent dengue caused by serotypes 1, 2, 3 and 4 of the dengue virus in people from 9 to 45 years old living in endemic areas, considering that the areas will be those established from epidemiological data by the Ministry of Health.

This media consulted ANMAT sources, who specified that currently “the Dengvaxia vaccine is still authorized” in the country. In this regard, Florencia Esquivel, medical director of Sanofi Vaccines for the Southern Cone, clarified to Infobae: “In Argentina, Dengvaxia was approved in March 2017 by ANMAT with the indication of 9 to 45 years. Subsequently, an update of the package leaflet was presented that includes a warning for those who have not suffered from the disease. This update was approved by ANMAT in June 2020. Currently the vaccine is indicated for people aged 6 to 45 years with previous dengue infection confirmed by a test, with a schedule of 3 doses at 0, 6 and 12 months.

LEAVE A REPLY

Please enter your comment!
Please enter your name here