The Butantan Institute today (16) submitted to the National Health Surveillance Agency (Anvisa) the documents for approval of its dengue vaccine, the first in the world in a single dose.
If authorization is granted, the institute will be able to produce 100 million doses for the Ministry of Health over the next three years.
Three packages of information about the vaccine were sent to Anvisa on Monday (16). It was the last batch of documents required for the authorization process for the manufacture of the so-called Butantan-DV.
“This is one of the greatest advances in health and science in the history of the country and a huge achievement at an international level. We will wait and respect all the procedures of Anvisa, an agency of the highest competence. But we are confident in the results that will come,” says Esper Kallás, director of the Butantan Institute.
The last participant in the vaccine's clinical trials completed follow-up in June. There were five years of trials and observation. The New England Journal of Medicine recently published the safety and efficacy data for the vaccine candidate. The numbers showed 79.6% overall efficacy in preventing cases of symptomatic dengue.
The Lancet Infectious Diseases has published data from phase three of the clinical trial, which showed 89% protection against severe dengue and dengue with warning signs, in addition to prolonged efficacy and safety for up to five years.
If the vaccine is approved by Anvisa, Butantan believes it will be able to supply one million doses next year. Another 100 million doses could be delivered in 2026 and 2027.
The information sent to Butantan on Monday (16) details the vaccine manufacturing processes. In other words, it demonstrates how the formulation and packaging tests meet the agency's requirements.
The vaccine factory, located at the Butantan Bioindustrial Center, was inspected and had its facilities approved by Anvisa. If authorization is granted to manufacture the vaccine, Butantan must submit a request for price authorization to the Chamber for the Regulation of the Medication Market.
After that, the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) will analyze the incorporation of the vaccine into the Unified Health System. This is the stage in which points such as reduction in hospitalizations and absenteeism from work, benefits and risks in the long term and for the Brazilian population are verified.
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