Negotiations for the production of Takeda Pharma's dengue fever vaccine Qdenga in Brazil have advanced. The Oswaldo Cruz Foundation (Fiocruz) formally submitted a request to the Ministry of Health about 15 days ago for technology transfer and production of the vaccine in the country.
The request was made through a Productive Development Partnership (PDP), an unprecedented mechanism for the dengue fever vaccine. The process for local production of Qdenga is in the submission stage, meaning the Ministry of Health is yet to assess the project's feasibility.
In 2009, there was a technology transfer of the 10-valent pneumococcal vaccine from GSK. At that time, however, the process was not through PDP as the program did not exist. It became part of the program in 2012.
Fiocruz and Takeda confirmed that a request was formalized with the Ministry of Health. “Further information can be detailed after the submitted proposal is assessed,” Fiocruz stated.
In an interview with Valor in August, the CEO of Takeda Brazil, José Manuel Caamaño, said there were discussions regarding local production. “There have been discussions regarding a possible project to be submitted to the Brazilian government to help to have local production of the vaccine, which could also help in the global production of the dengue fever vaccine,” he said at the time.
The partnership between Takeda and Fiocruz is part of the federal government's goal to reduce dependence on the international industry in medicines, materials, and digital health regarded as strategic for the Unified Health System (SUS). Initiatives aimed at health emergencies, such as dengue fever, are also on the priority list. The partnerships involve Brazilian public-sector institutions and private-sector companies.
Currently, Qdenga is the main dengue fever vaccine in the world. The Brazilian market is the largest global consumer of the vaccine, and a significant portion of the production, currently in a factory located in Germany, is sold in Brazil. This year, Takeda, a Japanese drugmaker, is allocating 6.5 million doses to the Brazilian government, with another 9 million planned for 2025, with a focus on the public health system.
Takeda does not disclose current production but points out that by 2030, its goal is to produce 100 million doses of the vaccine per year. This production will come from a new manufacturing unit in Germany and a new partnership with Indian pharmaceutical company Biological E. Limited (BE). “Unfortunately, dengue fever cases will continue to rise; we have climate effects, and many regions in the world risk being affected,” Mr. Caamaño stated.
In this race, there's also the vaccine by Butantan Institute, which in August released data from phase 3 research. The study, published in the scientific journal “The Lancet Infectious Diseases,” revealed 89% efficacy for severe cases, in addition to prolonged efficacy and safety for up to five years.
Brazil is considered the priority market for Takeda due to the dengue fever epidemic that hit the country. According to data from the arbovirus monitoring panel of the Ministry of Health, 6.5 million likely cases and 5,600 deaths from the disease were recorded this year (up to mid-October).
“More than two million people have been vaccinated with the doses we delivered. We have a vaccine that has been studied for over 15 years, with more than 28,000 study participants in 13 countries, including Brazil. It is a product that has demonstrated efficacy and safety in a global population,” the Takeda Brazil CEO said. The pharma invests $4.8 billion per year in research and development (R&D), equivalent to 15% of its global revenue.
Mr. Caamaño also emphasized that Qdenga has “an effectiveness of 8 out of 10 vaccinated people not contracting the disease. The effectiveness is a reduction of 80% of dengue fever in the vaccinated population in the first 12 months and 90% of people who did not require hospitalization. That means 9 out of 10 people who contracted the disease were not hospitalized.”
One of Takeda's differentiators compared to Dengvaxia by the French laboratory Sanofi-Pasteur is that the Japanese vaccine can also be administered to the population that has not yet contracted the virus.
By Beth Koike, Valor — São Paulo