January 15, 2010

 

 Swine-use H1N1 vaccine approved under conditional license

posted January 1, 2010
 

A swine-use vaccine against the pandemic H1N1 influenza virus is available under a conditional license granted in early December 2009.

The Department of Agriculture granted a conditional license to Pfizer Animal Health to produce a vaccine intended to protect swine herds against the virus. Health authorities have discovered infections in swine herds in more than a dozen countries including the United States.

Cindy Smith, administrator of the USDA Animal and Plant Health Inspection Service, said in a press release that her agency and partners in animal health worked to expedite vaccine development.

"This vaccine will help producers protect their swine herds and protect themselves from economic losses in the event that their herds contract this virus," Smith said.

Conditional licenses for veterinary biologics are granted in response to special circumstances.

"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," the press release states.

Joelle Hayden, spokeswoman for the USDA-APHIS, said she could not disclose whether any other companies were pursuing conditional licenses for similar vaccines.

The conditional license is scheduled to last one year, at which time performance data are expected be evaluated to determine whether another conditional license or a regular product license should be issued.

Dr. D.L. "Hank" Harris, a professor at Iowa State University and president of Harrisvaccines Inc., said his company has been producing a swine-use vaccine against the pandemic influenza virus, and he hopes to be granted a conditional license in the first half of 2010. His vaccine has been used on swine in clients' herds for which veterinarians hired by his company as consultants have confirmed infection with the H1N1 virus.

Dr. Tom Burkgren, executive director of the American Association of Swine Veterinarians, said he was not sure what impact the vaccine would have for the industry, in that H1N1 has not been a severe problem among swine.

Dr. Burkgren said increased biosecurity on farms, particularly efforts to keep ill people away from swine, has paid dividends for producers.

Nevertheless, Dr. Burkgren said he applauds Pfizer and other companies that pursued vaccines for the virus and the USDA Center for Veterinary Biologics for working with producers.