The Ministry of Health announced, this Monday (8), which investigates 42 cases of people who presented more severe symptoms after vaccination against dengue, three of them required hospitalization and two of them died.
Also on Monday, the ministry had already announced the with the vaccine developed by the Butantan Institute.
Still in February, the SUS began vaccinating primary care health professionals against dengue first, with the forecast of immunizing 1.2 million frontline workers, in basic health units, for example. The serious cases recorded were identified in this target audience.
The Minister of Health, Alexandre Padilha, stated that it is not possible to conclude that the adverse events were caused by the vaccine, but they represent a warning sign and will be investigated by a committee of experts.
“This discontinuity has an objective which is precautionary action, so that the Ministry of Health, Anvisa [Agência Nacional de Vigilância Sanitária] and Butantan deepen the investigation into the 42 cases, which are episodes of adverse reactions to the vaccine, to look for risk factors in these people, do a kind of case-control study”, said at a press conference.
“The Ministry of Health has complete confidence in Butantan’s institutional capacity”, highlighted Padilha when emphasizing the importance of vaccination for reducing and eliminating diseases in the country.
The suspension only applies to the vaccine produced by Butantan, and does not include the Qdenga immunizer, produced by the Takeda laboratory and applied in the Unified Health System.
Serious cases
Of just over 500,000 doses administered across the country, 3,703 people had symptoms similar to dengue fever – 0.7% of the total number of people vaccinated.
Of these, 42 presented alarm symptoms, which are: abdominal pain, persistent vomiting or bleeding – 0.008% of those vaccinated – rare but unexpected events, as they were not reported during the vaccine study phase.
Three people from the healthcare sector presented serious symptoms and were hospitalized:
- A 39-year-old woman developed fever, myalgia and nausea six days after receiving the vaccine, progressing to symptoms of severe dengue, with shock and need for ICU; was discharged.
- A 48-year-old woman developed symptoms of severe dengue fever, with neurological impairment (meningoencephalitis) 19 days after vaccination; evolved into death.
- A man, 58 years old, developed a fever five days after vaccination, quickly progressing to severe dengue symptoms, with refractory shock; evolved into death.
People already vaccinated
According to Minister Alexandre Padilha, the population that received the vaccine from the Butantan Institute in the last 21 dias You will have special monitoring to identify any signs or any other adverse reaction.
The Ministry of Health’s guidance is to seek a health unit in case of intensification of the following symptoms: fever, intense and continuous abdominal pain, persistent vomiting, dizziness, bleeding, intense drowsiness, irritability, signs of dehydration or worsening of the general condition.
Reevaluation of the strategy
In a note, the Butantan Institute reported that the dengue vaccination will be temporarily interrupted to reevaluate the vaccination strategy. The measure aims to guarantee the safety of the population in the next stages of vaccination.
“The Butantan Institute, as already demonstrated in recent cases, will continue working with the utmost rigor to deepen information on the use of the vaccine so that, if its safety is confirmed, vaccination can be resumed soon, with complete peace of mind for the population served by the SUS”, said the institution.
According to the Institute, the vaccine had an overall efficacy of 79.6% and 89% against dengue grave in a study published in an international scientific journal. In the three municipalities where there was mass vaccination of the population, pharmacovigilance monitoring was positive, with no major cases of adverse reactions in the population.
*With information from Agência Brasil
