Amazonas temporarily suspends dengue vaccine from Butantan Laboratory
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Amazonas temporarily suspends dengue vaccine from Butantan Laboratory. Disclosure/FVS-RCP Amazonas temporarily suspended the application of the dengue vaccine developed by the Butantan Institute.
Amazonas temporarily suspends dengue vaccine from Butantan Laboratory.
Disclosure/FVS-RCP
Amazonas temporarily suspended the application of the dengue vaccine developed by the Butantan Institute. The preventive measure was announced this Monday (8) by the Amazonas Health Surveillance Foundation Dra. Rosemary Costa Pinto (FVS-RCP), following guidance from the Ministry of Health and the National Health Surveillance Agency (Anvisa).
The suspension was adopted after the Ministry of Health identified 42 cases of severe adverse reactions in vaccinated people, with signs compatible with those observed in cases of severe dengue, such as severe abdominal pain, persistent vomiting and bleeding. Among the records, three cases were classified as serious, including two deaths that are under investigation.
“In Amazonas, the vaccine was being offered to Primary Health Care professionals. Of the 25,580 doses received by the state, 5,780 have already been applied and there were reports of 84 events supposedly attributed to vaccination or immunization (Esavi), with no record of deaths related to the vaccine”, stated the director-president of FVS-RCP, Tatyana Amorim.
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The government of Amazonas did not inform whether any of the cases investigated by the Ministry of Health were registered in the state, nor did it detail the origin or distribution of the incidents investigated.
According to the FVS-RCP, the decision is preventive in nature and will remain in force until the conclusion of the analyzes conducted by the health authorities.
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The FVS-RCP Immunization Manager, Angela Desirée, informed that monitoring of vaccinated people will continue normally during the suspension period.
According to her, 916 people who received the vaccine in the last 21 days will be monitored by municipal immunization coordinations to identify possible adverse events and guarantee assistance, if necessary.
The Foundation reinforced that the suspension is temporary and preventive and does not change the importance of vaccination as a public health tool. The agency also highlighted that the measure demonstrates the functioning of the surveillance and monitoring systems responsible for continuously evaluating the safety of immunization agents used in the country.
Vaccination in Brazil
Developed by the Butantan Institute, the Butantan-DV vaccine is the first in the world applied in a single dose and the first entirely Brazilian. Immunization began at the beginning of this year with a focus on health professionals: they received 417 thousand doses.
Among the approximately 500 thousand vaccinated with Butantan-DV, 3,703 reports of adverse events were recorded, equivalent to 0.7% of the total. Of these records, 42 showed alarm signs and were classified as serious, which represents 0.008% of the total number of people immunized. All cases are under investigation.
Another 83,600 were applied to people aged between 15 and 49 in Botucatu (SP), Maranguape (CE) and Nova Lima (MG) – and in the Araguaína region, in Tocantins. According to the ministry, there were no reports of adverse events among residents of these regions.
And what happens now? States and municipalities will suspend application while cases of serious events and deaths are investigated. The government informed that it will contact the states to reinforce the search for possible adverse effects.
And who has already had the vaccine? Anyone who received doses in the last 21 days should follow up and be aware of reactions such as fever, abdominal pain, vomiting, among others.
In a statement, the Butantan Institute said it will follow the guidance of the Ministry of Health and Anvisa, with the suspension in a preventive manner to reevaluate the vaccination strategy.
Government announces suspension of dengue vaccination
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