Agencies recommend interruption during cases analysis; Immunizant was approved in Brazil in April
The regulatory agencies of drugs in the United States (FDA) and in Europe (EMA) have issued communications that recommend a break in the use of the vaccine Chikungunya In the elderly while evaluating the relationships of serious adverse events. In Brazil, the Immunizant was approved by the National Health Surveillance Agency (Anvisa) April 14 and is Incorporation into the Unified Health System (Sus) is under analysis.
THE Food and Drug Administration (FDA) And the control and prevention centers of diseases (CDC) in the United States recommend a temporary interruption in the application of IXCHIQ in individuals or more than 60 years. In Europe, the European Medicinal Agency (EMA) has been led the break for the elderly for 65 years. Other publics – individuals aged 18 and 59 in the United States and 12 to 64 in Europe – can be normally vaccinated.
The agencies claim that 17 serious adverse events have been reported, two of which with consequent deaths, 62-89 years that received the immunner all over the world – about 80,000 doses of Ixchiq were distributed globally and 40,000 have already been applied, estimates the Austrian Valneva Pharmaceutical, a manufacturer of the vaccine.
“One of the fatal cases involved an 84 -year -old man who developed encephalitis. The second case involved a 77 -year -old man with Parkinson’s disease whose difficulties in swallowing has worsened and may have caused the aspiration pneumonia, “says Ema. The two fatal cases occurred in the French department of abroad of La Réunion, where there is a vaccination campaign in progress after a recent burst of Chikungunya.
The entities point out that most of the relationships involve people with chronic medical conditions below and that events may not be connected to the immunior. “Many of the affected people also had other diseases and the exact cause of these adverse events and their relationships with the vaccine have not yet been determined,” underlines the European Agency.
Ema adds that your committee will review all the available data to evaluate the benefits and risks of the immunior and make a recommendation on the opportunity to be a change in terms of authorization. It also underlines that the vaccine should not be administered to people with an immune system weakened due to illness or medical care, regardless of age.
Valneva, in turn, says that “he undertakes to maintain the highest security standards and has been involved in a proactive way with the health authorities in all the territories in which Ixchiq is authorized to provide timely information on all known serious adverse events”.
The vaccine
Ixchiq contains a CEFA of the Chikungunya virus which has been attenuated (weakened) so as not to cause the disease. The logic is as follows: when a person receives the immunner, his immune system recognizes the weakened virus as “strange” and produces antibodies against him. If it is subsequently infected, your defenses recognize the invader and will be able to fight it more effectively.
In Brazil, the authorization of Anvisa It allows the application of the vaccine to people for 18 years and there is an analysis underway of its incorporation in the Sus. The registration request was submitted in collaboration with the Butantan Institutewhich works in another version of the immunior.
To the question about temporary restrictions abroad, Anvisa and Butann did not speak until the publication of this text. The content will be updated when the institutions are positioned on their own.
The disease
The disease is caused by the Chikungunya virus (Chikv), transmitted by the mosquitoes of the genre Aedes.
According to the Ministry of HealthSymptoms include fever, intense joint pain, headache and muscles, swelling in the joints, red spots on the body, nausea and vomiting.
Most patients recover in a week, but some remain by feeling joint pain and a portion can develop a serious acute disease, associated with multiple organ failure.
By 2025, the country has already represented 91,110 likely cases of illness, according to the ministry. 75 deaths and 71 other fatal cases have been confirmed in the investigation.
Source: Terra
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