Anvisa approves record of the first vaccine against dengue in BrazilEven released by Anvisa, still lack the definition of the value of each dose.
He left on Monday (28), the approval of the first vaccine against dengue record in Brazil: a Dengvaxia, French Sanofi Pasteur. Although approved for marketing by the National Health Surveillance Agency (Anvisa), still lack the Drug Market Regulation Chamber set the value of each dose, process that lasts about three months, but no later.
Initially, the drug will be available for the particular network of laboratories. Set the price, the National Technology Incorporation Commission SUS will evaluate whether it is worthwhile incorporating the product to the public system Immunizations. The government will evaluate costs, effectiveness and epidemiological and budgetary impacts of incorporation of the vaccine to the Health System.
The vaccine is recommended for people between 9 e 45 years and protects against the four types of dengue virus. The promise of the manufacturer is protection 93% against severe disease, reduction of 80% of hospitalizations and overall effectiveness of 66% against all types of viruses. The medicine should start to be sold in the country in the first half of 2016 and the laboratory's production capacity is 100 million doses per year.
The immunizing should be applied in three doses, at six monthly intervals, however, according to the Sanofi medical director, Sheila Homsani, from the first dose protects the product almost 70% of people. "The vaccine is effective from the first dose, shielding around 70% the immunized. The need for other doses is because protection is falling over time, not maintained without the other two. The protection only remains for many years when taking three doses ", said Sheila.
Earlier this month, Mexico was the first country to register the vaccine against dengue Sanofi, for a while, a registered not only world. Then the product was released in the Philippines. Brazil is the third country to have the record of immunizing. The clinical development of the product involved over 20 studies, and more 40 thousand participants, among children, adolescents and adults, in 15 countries.
Ministry of Health data show that until the first week of December, 839 people died from dengue, increased 80% about 2014.