Brazil research center applies for registration of its dengue vaccine
Brazil’s Butantan Institute today (Dec. 16) submitted the documents for the approval of its dengue vaccine—the world’s first single-dose shot—to the national drug authority Anvisa. If approval is granted, the institute will be able to produce 100 million doses for the Ministry of Health over the next three years.
Three sets of documents on the inoculation were sent. It was the last batch of papers needed for the authorization process to manufacture Butantan-DV, as the jab is called.
“This is one of the greatest breakthroughs in health care and science in the history of Brazil and a huge achievement at international level. We will wait and respect all the procedures of Anvisa, a highly competent body. But we are confident of the results to come,” says Esper Kallás, director of the Butantan Institute.
The last participant in the clinical trials completed follow-up in June. It had been five years of trials and observation. The New England Journal of Medicine recently published the vaccine candidate’s safety and efficacy data. The figures showed 79.6 percent overall efficacy in preventing cases of symptomatic dengue.
The Lancet Infectious Diseases, in turn, published data from phase three of the clinical trial, which showed 89 percent protection against severe dengue and dengue with alarm signs, as well as prolonged efficacy and safety for up to five years.
The institute believes it can supply one million doses next year. Another 100 million doses could be delivered in 2026 and 2027.
The information sent by Butantan details the vaccine’s manufacturing process. They show how the formulation and packaging tests meet Anvisa’s requirements.
The vaccine factory, which is located at the Butantan Bioindustrial Center, was inspected and had its facilities approved by Anvisa. Should it be authorized to manufacture the inoculation, Butantan must submit a price authorization request to the Chamber for the Market Regulation of Medicines.
