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ANVISA issued, on Monday (21), the Board Resolution (RDC) No 46/2013, showing the determinations that should be adopted for influenza vaccines used in Brazil in 2014.
The trivalent influenza vaccines used in Brazil from February 2014 shall mandatorily contain three types of virus strains in combination: a virus similar to influenza viruses A/California/7/2009 (H1N1) pdm09, a virus similar to the virus A/Texas/50/2012 influenza (H3N2) and influenza virus similar to B/Massachusetts/2/2012.
Already quadrivalents influenza vaccines should contain the three viruses described above and a virus similar to influenza viruses B/Brisbane/60/2008. The agency notes that the strains are similar to A/Christchurch/16/2010 virus strains A/California/7/2009.
Can only be produced, marketed or used influenza vaccines which are in accordance with the provisions and the specific compositions described in the DRC. Also according to the Resolution, is forbidden to use any other virus strains in the influenza vaccines in the country. Vaccines currently marketed or manufactured outside of these determinations shall be withdrawn from the market.
The composition of the influenza vaccine is updated every year, according to the circulating viruses, to ensure the effectiveness of the product. According to ANVISA, the resolution is in accordance with the recommendations of the World Health Organization (WHO) for the Southern Hemisphere