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Published on 04/11/2016
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Those Who Have Never Had Dengue Fever Shouldn't Take the Available Vaccine
11/30/2017 - 12h39
The National Sanitary Vigilance Agency (Anvisa) has decided to limit the recommendation for use of the only dengue fever vaccine available in the country.
The vaccine is no longer recommended for people who have never had any contact with the virus, according to a written communication published by the agency on Wednesday (the 29th).
Produced by Sanofi Pasteur, the vaccine is the first that has been approved for use in Brazil against the virus. The Butantã Institute has also developed a vaccine, but it hasn't yet been introduced into the market.
|Alvin Baez - 06.mar.2016/Reuters|
|Aedes Aegypti Mosquitos|
The restrictive measure was adopted after the laboratory presented preliminary data to the agency that point to a risk for individuals who are seronegative for dengue fever in developing more serious forms of the virus after being stung by the Aedes aegypti mosquito which carries and spreads dengue and other viruses.
The instruction leaflet which accompanies the vaccine, which is commercialized under the tradename Dengvaxia, is expected to be updated with the recommendation that Anvisa has re-evaluated the risks and benefits of the product. Currently, the vaccine is only available through private networks and costs as much as R$ 135 (US$ 41.54) per dose.
At the national level, the vaccine had already been viewed with skepticism by technicians from the Ministry of Health, who consider its level of efficacy - around 66%, to be low.
Sanofi Pasteur, who is responsible for the only vaccine available in Brazil, declared that it has been monitoring people who were vaccinated during clinical trials and that it alerted Anvisa and other regulatory agencies regarding the new findings and the need to alter the usage recommendations. An advisory communication is expected to be sent to vaccination clinics as well.
The findings don't affect the recommendation for the use of the vaccine for those who have already had contact with the virus, to whom the vaccine remains available as a recommendation in 19 countries.
Translated by LLOYD HARDER