| 2009 H1N1 flu information |
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| USDA issues conditional license for Pandemic H1N1 vaccine for swine |
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USDA has issued a conditional license to Pfizer Animal Health, of Lincoln, Neb., for a pandemic H1N1 influenza vaccine intended to vaccinate pigs against the 2009 pandemic H1N1 influenza virus. This is the first pandemic H1N1 influenza vaccine license issued by USDA.
“This vaccine will help producers protect their swine herds and protect themselves from economic losses in the event that their herds contract this virus.” said Cindy Smith, Administrator of the U.S. Department of Agriculture Animal and Plant Health Inspection Service.
USDA's Animal and Plant Health Inspection Service issues conditional licenses for veterinary biologics products to meet an emergency situation, limited market, local situation or special circumstance. The special circumstance addressed here is the need for a product to vaccinate pigs against the 2009 pandemic H1N1 virus. Under these regulations, a product that is shown to be pure and safe and that demonstrates a reasonable expectation of efficacy may be licensed while data to establish efficacy and potency are still being obtained.
Conditional licenses are generally issued with restrictions and for a limited period of time. In this, case, the product has been issued a conditional license for one year. At the end of the conditional license period, data obtained in support of the product’s performance will be evaluated to determine if the conditional license should be renewed or if a regular product license may be issued.
ODA has granted permission to Pfizer to sell this product to Oregon Veterinarians. In Oregon, the product is restricted to use by, or under the supervision of, a veterinarian. Producers are encouraged to consult with their veterinarian for further details
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