El País Editorial
The Ministry of Public Health (MSP) summoned the National Vaccine Advisory Commission (CNAV) to evaluate the application of the dengue vaccine. As El País learned, the meeting on this matter, amid an increase in cases in the region and the detection of the first indigenous cases in several areas of the country, will be this Friday, the informants noted.
Qdenga, the dengue vaccine developed by the Japanese laboratory Takeda, was approved for use in Europe, the United Kingdom, Brazil, Argentina, Indonesia and Thailand, among other markets, the EFE agency reported.
When consulted by El País, virologist Santiago Mirazo pointed out that the Qdenga vaccine, which has an attenuated virus, “is still in the surveillance phase and its effectiveness is not very clear,” and the World Health Organization (WHO) “does not recommend its use.” application in all cases”. In this way, for the expert “there are several things to put on the table before deciding to vaccinate.”
The infectologist Julio Medina indicated yesterday on his account on the social network This “will give time to see the results of its implementation in other countries and have more robust efficacy and safety data,” he said.
The Minister of Public Health, Karina Rando, said yesterday at a press conference that “some Latin American countries have considered administering it,” such as Brazil. “Uruguay is evaluating this process with the experts and with the call that will be made soon to the CNAV,” she added.
In Argentina, Qdenga was approved by the National Administration of Medicines, Food and Medical Technology (Anmat) last April, and has been available since November 2023. Two doses are applied, under medical prescription, at an interval of three months, for a Total cost is around 150,000 Argentine pesos, about US$150.
The quadrivalent vaccine (against DEN-1, DEN-2, DEN-3 and DEN-4), “TKA-003”, as Qdenga is also called, was recommended by the WHO in October 2023. It was the first time that the international organization recommended the use of a dose against the virus, which generates massive infections in Brazil, Argentina, among other countries.
The WHO recommended its use for young people between 6 and 16 years old, in those areas where dengue has become a major public health problem, the director general of the WHO, Tedros Adhanom Ghebreyesus, pointed out at the time.
At the XI ad hoc Meeting of the Technical Advisory Group (GTA) on Vaccine Preventable Diseases of the Pan American Health Organization (PAHO), several comments were made about Qdenga, published in January of this year.
Takeda’s “quadrivalent live attenuated dengue” vaccine “demonstrated efficacy in endemic countries in preventing symptomatic dengue disease (i.e., virologically confirmed dengue, or VCD) and hospitalization in children aged 4 to 16 years who were seropositive (that is, with dengue infection before vaccination) against the four serotypes of the virus.
“It should be noted that the efficacy of the vaccine was substantially lower in children vaccinated at 4-5 years of age compared to those who received the vaccine between 6 and 16 years of age,” the PAHO statement noted.
The WHO Strategic Advisory Group of Experts (SAGE) on Immunization, after meeting at the end of last September, “recommended Member States to consider the use of the TAK-003 vaccine for children aged 6 to 16 years old who live in environments with a high burden of dengue disease and high intensity of transmission.
“However, there remain important knowledge gaps regarding the safety and effectiveness of this vaccine against dengue viruses type 3 and 4 in reference seronegative people,” added the health agency.
“PAHO accepts the GTA’s support for the SAGE recommendation on the introduction of the TAK-003 vaccine in these settings, provided that careful measures are taken to ensure the evaluation and monitoring of the safety and effectiveness of the vaccine, and that communities and health professionals involved are fully informed of the possible benefits and risks and support the use of the vaccine,” it was stated in January.
In that sense, it was noted that “PAHO recommends that any introduction of the TAK-003 vaccine in the country be considered a pilot test and be accompanied by a robust phase 4 post-marketing study.”
As well as that PAHO “accepts the GTA recommendation that Member States do not implement immunization programs throughout the country with the TAK-003 vaccine at this time.” And that “Member States that do not have a vaccination platform for adolescents should not consider the introduction of the TAK-003 vaccine at this time.”
It was also noted that “PAHO accepts the GTA’s recommendation that Takeda undertake a phase 4 vaccine trial to address data gaps.”
In addition to Takeda, there are two more vaccine developments. The “Butantan DV” vaccine, from the Butantan Institute of Brazil, which hopes to submit the registration application to the National Health Surveillance Agency (Anvisa) for analysis between June and July. And also Dengvaxia, from Sanofi-Pasteur, which can be applied only to those who have previously had dengue.
2024-03-06 18:39:54
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