USDA ISSUES CONDITIONAL LICENSE FOR PANDEMIC H1N1 VACCINE FOR SWINE
WASHINGTON, Dec. 11, 2009 - USDA today announced that it 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.
“USDA and its partners in animal health have worked hard to expedite the development of a vaccine for the 2009 pandemic H1N1 influenza virus,” said Cindy Smith, Administrator of the U.S. Department of Agriculture Animal and Plant Health Inspection Service. “This vaccine will help producers protect their swine herds and protect themselves from economic losses in the event that their herds contract this virus.”
On June 2, 2009, the Center for Veterinary Biologics informed interested parties that the agency would provide pre-approved Master Seed Viruses to be used for development of a conditionally licensed pandemic H1N1 vaccine to protect swine. In the event that the pandemic H1N1 virus would become an emerging disease in swine, the availability of pre-approved Master Seed Viruses would facilitate a more rapid response should vaccine production be warranted. On September 10, 2009, Secretary Vilsack announced that USDA was expediting development of the H1N1 vaccine to protect swine.
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. The product is restricted to use by a veterinarian in those states where use of the product has been approved by the appropriate state regulatory authorities.
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