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The Director of Regulatory Affairs, Quality and PMO (Project Management Office) at the Butantan Institute, Rosilane de Aquino, celebrated the approval of Brazil’s new dengue vaccine and confirmed that more than one million doses are already prepared for delivery to the Unified Health System (SUS). “Without a doubt, we’ve been celebrating since November 26, when Anvisa announced its decision,” she told BdF Radio.
Aquino explained that the rollout strategy will be defined by the federal government. “Population groups and regions to be prioritized will be determined by the Ministry of Health,” she said. She also revealed that Butantan manufactured doses “at risk,” even before regulatory approval, confident in the process. “We were fully convinced the vaccine would be approved,” she added.
The director highlighted that the institute is already working with Brazil’s National Immunization Program (PNI) to ensure the vaccine’s incorporation into the calendar. “We currently have over one million doses available for the Ministry of Health, ready to be delivered as soon as contracts are signed,” she noted. She recalled that the country already uses an imported vaccine distributed to municipalities for children aged 10 to 14, and stated that the Brazilian-made vaccine will complement this supply, offering a single-dose immunization.
Aquino emphasized the strategic importance of domestic vaccine production. “This is a victory for Brazilian science. When investment is properly directed toward public interest, we are fully capable of producing what is needed for our health realities,” she said. She pointed out that diseases such as dengue are often neglected by major pharmaceutical companies, making it crucial for Global South countries to take charge of their own production, with potential for future export through international organizations.
Regarding the vaccine’s development, Aquino noted that the project began in 2009 and involved “the largest clinical trial ever conducted in Brazil, with more than 16,000 volunteers.” Public participation, she said, was decisive. “It is what allows us to reach a clear outcome that demonstrates, clearly and convincingly, the safety and efficacy of the product,” she concluded.
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