The European Medicines Agency has approved the first two avian influenza vaccines for birds that the agency says will reduce mortality and virus excretion in poultry exposed to the disease.
The European Medicines Agency (EMEA) gave a positive opinion to Nobilis Influenza H5N2 from Intervet International BV, a subsidiary of Netherlands-based Akzo Nobel BV, and Poulvac FluFend H5N3 RG from Fort Dodge Animal Health, a division of U.S.-based Wyeth.
Both are inactive, adjuvanted avian influenza vaccines administered by injection. Nobilis is for use in chickens, and Poulvac is intended for use in chickens and Pekin ducks.
The agency's Committee for Medicinal Products for Veterinary Use approved the vaccines under “exceptional circumstances,” anticipating a period of high risk for infection in the autumn and winter. The committee decided that the benefit of using the vaccines outweighed the risks but will review the vaccines annually.
Under the approval, EMEA also requires enhanced safety monitoring by the two manufacturers.
London-based EMEA is a division of the European Union that offers pharmaceutical manufacturers a way to obtain a single approval for the 25 EU countries. A positive opinion from EMEA is forwarded to the European Commission for single marketing approval.
Many experts believe reducing the number of H5N1 infections in birds may be the best path to preventing a pandemic outbreak in humans.
The density of both humans and poultry in the world, coupled with trade, travel, and a history of avian influenza virus strains that mutate into forms that spread easily among humans, means “all the ingredients are in place for the occurrence of another pandemic,” said Dr. Didier Houssin, interministry delegate for the fight against avian influenza in the French Ministry of Health, Paris.
“Prevention of human contamination should also be the first line of defense against a potential human pandemic,” Dr. Houssin told the First International Conference on Avian Influenza in Humans.
Among the strategies countries should consider is the vaccination of poultry, although he warned that this step may not always prevent avian influenza from entering a country. “Measures taken at the country level are not sufficient, because wild birds know no or almost no frontiers,” Dr. Houssin said.