Brazil: 2 deaths, dozens of cases with warning signs, prompts temporary discontinuation of the current Butantan-DV vaccine
In a follow-up to a report from February, the Brazil Ministry of Health announced Monday the temporary discontinuation of the current Butantan-DV vaccination strategy against dengue.
The measure, adopted as a precaution and based on consensus between the Ministry of Health and the National Health Surveillance Agency (Anvisa), comes after the registration of 42 cases with warning signs, such as intense abdominal pain, persistent vomiting, and bleeding. Among them, three were classified as serious, including two deaths.
These are rare events that account for 0.008% of a total of 500,000 doses administered up to May 30th - and there is still no conclusive result regarding their correlation with the vaccine.
This discontinuation has a purpose. First, it is a precautionary measure that should always guide those who respect life and those who respect science, even more so when we are talking about vaccination. Second, it allows the Ministry of Health, Anvisa (Brazilian Health Regulatory Agency), and the Butantan Institute to deepen the investigation of the cases, especially the registered deaths, for which there is still not enough information to establish a causal relationship with the vaccine,” highlighted the Minister of Health, Alexandre Padilha.
The vaccination strategy using the Butantan Institute’s vaccine was aimed at primary healthcare professionals and, more broadly, at the 15-49 age group in three cities – Botucatu/SP, Maranguape/CE, and Nova Lima/MG – and the Araguaína region in Tocantins. The campaign began in January of this year.
Before being incorporated into the SUS (Brazilian Public Health System), the Butantan-DV vaccine underwent all the evaluation stages required by regulatory bodies, with results demonstrating its safety and efficacy.
The decision to temporarily suspend the application of the immunizing agent was made after discussions with the Interinstitutional Committee for Pharmacovigilance of Vaccines and other Immunobiologicals (Cifavi) and the Technical Advisory Chamber on Immunization (Ctai), bodies composed of representatives from the Ministry of Health, Anvisa, and specialists.
It is important to highlight that this measure does not invalidate the vaccine’s effectiveness nor alter the evidence of protection observed so far. Those who have already been immunized remain protected, and epidemiological surveillance continues to monitor the vaccinated population.
For those who have already received the vaccine, the recommendation is to monitor their health for 21 days after the vaccination. In case of symptoms such as fever, intense abdominal pain, persistent vomiting, bleeding, dizziness, excessive drowsiness, signs of dehydration, or worsening of general condition, medical attention should be sought immediately.
From now on, health teams will reinforce surveillance of vaccinated patients who present dengue symptoms, paying special attention to recognizing warning signs and signs of severity. They should also intensify case reporting, activate local surveillance, and ensure immediate referral for clinical care when necessary.