First dengue vaccine approved in Brazil

The first vaccine for dengue fever prevention, Dengvaxia, was approved Monday (Dec. 28) in Brazil. Although approved for sale by the National Health Surveillance Agency (ANVISA), the new vaccine is still pending its final dose pricing to be decided by the Drug Industry Regulating Board, a process that lasts an average three months.
 
Manufactured by France's Sanofi Pasteur pharmaceutical lab, it will initially be available from private health services. Once the price has been set, Brazil's government will be able to weigh effectiveness against the cost and epidemiological and budget impact to decide if it is worth providing for free through the public health system (SUS).

The vaccine is recommended for people aged between 9 and 45 years and provides protection from the four dengue virus serotypes. The manufacturer promises it can provide 93% protection from severe cases of the disease, reduce hospital stays by 80% and provide an overall 66% effectiveness against all dengue virus serotypes. Sales should begin in the first half of 2016, and the annual production capacity is 100 million doses.

It is administered in three doses, at six-month intervals. According to Sheila Homsani, medical director for Sanofi Pasteur, the product protects almost 70% of patients it has been administered to at the first dose. “The additional doses are needed because the protection level declines over time—it doesn't hold good for long with the first dose alone. Only administering all three doses can ensure years-long protection,” she explained.

Mexico and the Philippines were the first countries to approve Sanofi's dengue vaccine, the only of its kind to have been approved anywhere in the world. Brazil has been the third country to approve it. It took over 20 studies and more than 40,000 subjects, including children, teenagers, and adults across 15 countries, to complete clinical development.

As of the first week of December, 839 people died from dengue in Brazil in 2015, 80% more than in 2014.

Translated by Mayra Borges