At least 3 people had anaphylactic shock due to the dengue vaccine, says ministry

The Ministry of Health reported this Friday (8) that at least three people suffered anaphylactic shock – a serious reaction with more than one body system affected – after using the dengue vaccine since the beginning of the application last month. The survey was released late in the morning at a press conference to update the epidemic numbers in the country, which already has 1.3 million confirmed and probable cases.

According to the ministry, the entire immunization campaign has already received 529 notifications of “events” possibly associated with the Qdenga vaccine, within a universe of 365 thousand doses applied. Of these notifications, 80% were classified as mild and common.

However, 70 of them were classified as allergic reactions such as immediate hypersensitivity (28), local reactions such as redness and itching (11), urticaria or skin reactions (10) and in fact 16 with more serious symptoms such as diarrhea, pulmonary manifestations such as bronchospasms and cough. , and reaching anaphylaxis in three of these cases.

Eder Gatti Fernandes, director of the National Immunization Program (PNI) department of the Ministry of Health, explained 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 cases were registered both in applications made by the SUS and in private clinics. He explained that they varied between age groups, with the youngest being four years old and the oldest being 21 years old, in different municipalities and without having one or another specific batch of the vaccine.

Two of the reactions took place in Dourados (MS), with children aged 4 and 6 right at the beginning of the campaign, and who recovered without consequences, according to the ministry. “The increase in anaphylaxis was not initially seen in clinical trials [da vacina]”, explained doctor Julio Croda, from the Technical Chamber of Immunizations, who stated that the ministry is monitoring.

Despite considering the number of cases of reaction to the vaccine low, the PNI director stated that more records could occur due to the lack of real-time notifications, as many health units lack connectivity. The data could take up to two months to reach the ministry, he said.

The cases led the ministry’s pharmacovigilance committee to prepare a technical note (see in full) to communicate what happened and make recommendations, such as asking whether the person who will receive the vaccine has any history of allergies, waiting 15 to 30 minutes in the unit after application to check if there will be any reaction, apply in a place that is able to provide the necessary assistance, and avoid concomitant 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.

According to the ministry, the current immunization campaign does not aim to end the current epidemic in progress in the country, which already affects 9 states. But, 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).