This Friday (8), the Ministry of Health announced that since the start of the application of the dengue vaccine last month, at least three individuals have had anaphylactic shock, a serious reaction that affects more than one body system. This information was released late in the morning at a press conference that aimed to update data on the epidemic in the country. So far, the country has recorded 1.3 million confirmed and probable cases.
According to the department, the total immunization campaign has already had 529 notifications of “events” that could possibly be linked to the Qdenga vaccine, given the total of 365 thousand doses administered. Of these reports, 80% were considered mild and common.
However, 70 were categorized as allergic reactions, including immediate hypersensitivity (28), local reactions such as redness and itching (11), urticaria or skin reactions (10). In fact, 16 presented more severe symptoms, such as diarrhea, pulmonary manifestations such as bronchospasms and cough, culminating in anaphylaxis in three of these cases.
The director of the National Immunization Program (PNI) department of the Ministry of Health, Eder Gatti Fernandes, clarified that the anaphylaxis reactions were quick and did not require emergency hospital care.
“All of these reactions occur within a short period of time after vaccination, that is, the average is 10 minutes. All of them received due care, were treated and progressed towards recovery, there were no hospitalizations. In other words, these are cases that are resolved immediately”, he highlighted.
According to Fernandes, the incidents occurred in both scenarios, both in the SUS and in private clinics. He clarified that the variation occurred between different age groups, with the youngest individual being four years old and the oldest being 21 years old. These cases were reported in several municipalities and were not concentrated in a specific batch of vaccine.
The reactions occurred with two children aged 4 and 6 in Dourados (MS) at the beginning of the campaign, but they recovered without consequences, according to the ministry. Doctor Julio Croda, from the Technical Chamber of Immunizations, explained that “The increase in anaphylaxis was not initially seen in clinical trials [da vacina]”. He stated that the ministry is monitoring the situation.
The director of the PNI, despite finding the number of reactions to the vaccine small, admitted that there may be more records due to the lack of real-time notifications. This occurs because many health units do not have connectivity. He mentioned that the data could take up to two months to be sent to the ministry.
The ministry’s pharmacovigilance committee was led to prepare a technical note (see in full) in response to the cases, with the aim of communicating the events and making recommendations. These recommendations include asking whether the individual who will receive the vaccine has a history of allergies, asking them to wait 15 to 30 minutes in the unit after the application to check if any reaction will occur, ensuring that the application is carried out in a place with suitable conditions. adequate to provide necessary assistance, and avoid simultaneous vaccination.
“For the Ministry of Health, it is considered a safe and effective vaccine. The strategy continues, the pharmacovigilance system continues to analyze the data and we will continue with our surveillance”, he added.
As indicated by the department, the current immunization campaign does not seek to eradicate the current epidemic taking place in the country, which already affects 9 states. However, the aim is to protect children and adolescents in the long term.
“It is a first step towards protecting the Brazilian population, which begins as recommended by the WHO in this age group of 10 to 14 years old”, explained Nereu Henrique Mansano, technical advisor to the National Council of Health Secretaries (Conass). The information is from Gazeta do Povo.