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The Butantan Institute and US pharmaceutical group MSD signed a partnership agreement on Wednesday for the research and production of the dengue vaccine (12). With this agreement, Butantan will provide information on the immunizer that is about to be tested in Brazil and could receive up to $ 101 million.
The vaccine strain to which the partnership relates was developed by the US National Institutes of Health (NIH). The Butantan Institute, a state government-owned laboratory in São Paulo, and MSD are working on dengue vaccines using the same strain, but Butantan's is at a more advanced stage.
In May of this year, Butantan acquired the patent for vaccine production in the United States. The drug is being tested with 17,000 volunteers in 14 research centers across Brazil. Production should start at the end of 2019. The marketing and distribution to the population depend on the end of studies, which does not have a specific deadline.
As part of a knowledge exchange agreement signed between the Butantan Institute and MSD, the US pharmaceutical group could accelerate its vaccine development process with information from clinical trials conducted by Butantan. The Brazilian public laboratory will receive an advance payment of $ 26 million and could receive an additional $ 75 million with new milestones related to vaccine development, as well as access to vaccine test data in areas of the world where the giant Pharmaceutical Country of Asia
When the clinical trials of both laboratories are at the same stage, everyone will be able to produce their own vaccine and new partnerships will be opened. Butantan will continue to be responsible for manufacturing and marketing its vaccine in Brazil. In the future, Butantan could collect royalties on MSD vaccine sales abroad.
Butantan had already established partnerships with MSD to transfer technology to produce vaccines against HPV and hepatitis A. However, unlike the current partnership, was the US pharmaceutical company that had provided information and knowledge on the production of immunizers for the Brazilian public laboratory in the previous cases.
"This is the first such transfer between a Brazilian institute and a global pharmaceutical company in The relationship was reversed, before it was north-south, now it's south-north" said Dimas Tadeu Covas, director of the Butantan Institute. For Roger Perlmutter, global president of clinical research at MSD, this agreement "reflects the tremendous progress made so far by scientists and doctors at the Butantan Institute".
Vaccination against dengue fever
There is currently a race for public and private laboratories to develop a safe and effective dengue vaccine to be produced on a large scale. There are four serotypes of the dengue virus, which are transmitted by the bite of a mosquito Aedes aegypti . The disease is endemic in more than 110 different countries, mainly in the tropical regions of Oceania, Africa, the Caribbean and the Americas.
Anyone infected with any of the four serotypes of the virus is immune to that particular serotype and can contract the disease if it is contaminated. by the other three. The second infection with the disease tends to be more serious.
The first vaccine of its kind to arrive on the market is Dengvaxia, from the French company Sanofi Pasteur, which ends up being contraindicated for those who have never suffered from dengue fever. The overall effectiveness of dengvaxie is 66%, considered low by specialists.
Japanese Takeda vaccines and the Butantan Institute (made from the NIH strain) are the most advanced test stage.
Butantan's vaccine is late-stage
The Butantan Institute vaccine is made from attenuated viruses and protects against the four existing types of the disease. Preliminary data indicate that butantan vaccine is safe for people aged 2 to 59, including those who have never had the disease, which encourages the body to produce antibodies. in a balanced way against the four serotypes.
According to Alexander Preciso. Director of the Division of Clinical Trials and Pharmacovigilance at the Butantan Institute, the expected efficacy of the vaccine is greater than 80% and would be warranted with a single dose. The final studies are not yet completed.
The development of the vaccine in Brazil had already enabled Brazil to invest R $ 224 million, coming from Fapesp (Foundation for Research Support) and BNDES (National Bank for Economic Development). and Social), the Butantan Foundation and the Ministry of Health.
Upon completion of the clinical trials phase, the registration application may be directed to Anvisa (National Health Surveillance Agency), which is responsible for authorizing the application of the vaccine in the country. .
Announced in 2015, the Governor of São Paulo, Geraldo Alckmin (PSDB), had then promised vaccination until 2017. The decrease in the number of cases of the disease in the country prevented the application vaccination in voluntary groups, which delayed the study. The state government had also promised to build a dose plant, which was due to be ready by the end of last year, but it was not completed on schedule. The new forecast is for 2019.
The Sanofi vaccine was the first to be put on the market
The first dengue vaccine on the market, Dengvaxia, was licensed in several countries in Asia and from Latin America. In Brazil, the vaccine was registered by Anvisa in December 2015. Sanofi revealed in November 2017 that dengvaxia could increase the risk of serious illness in people who have never been exposed to the virus . The WHO (World Health Organization) and Anvisa have begun to consider the contraindicated vaccination for this public.
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