Bird flu vaccine conditionally approved, still can't be sold

A vaccine to help protect the nation's chickens from avian influenza after more than 48 million birds died during an outbreak this year has cleared a first hurdle, with the Agriculture Department granting its maker a "conditional" license.

Harrisvaccines announced on Monday that the department had granted the license, a type issued to deal with emergencies, market limitations or other special circumstances, for a vaccine that can be easily updated as new strains of the virus appear.

But the company does not yet have government approval to sell the drug.

"The United states Department of Agriculture (USDA) has said no vaccine is to be used for highly pathenogenic avian influenza," said Joel Harris, vice president for sales and marketing at Harrisvaccines, which was founded by his father, Hank Harris. "What this license does is that if they allow a vaccine to be used, we would immediately have a USDA licensed product available for producers."

The H5N2 strain of avian influenza that did most of the damage in the spring is extremely virulent, moving from one or two birds to entire flocks within 24 to 48 hours. It is believed to have been spread by wild birds migrating north, and poultry and egg producers have been concerned that birds will bring it or another equally devastating strain back with them as they begin their migration south this winter.

Last month, the Agriculture Department announced plans to create a stockpile of vaccine for the Eurasian H5 virus strain that destroyed flocks earlier this year and asked vaccine developers to submit their proposals. Harris said the stockpile would contain 500 million doses of vaccines, most likely supplied by several companies.

A USDA. spokeswoman referred questions about the vaccine to the department's announcement about the stockpile.

Harris said Harrisvaccines, which previously developed a vaccine used to combat a deadly pork virus, had been working to develop such a vaccine since the outbreak began, and it submitted its vaccine to the USDA's Southeast Poultry Research Center for evaluation.

The company's technology creates a synthetic version of a virus's genetic code and uses that to make a vaccine, eliminating the need to work with a live virus in making the drug.

Harrisvaccines is continuing to test the efficacy of the vaccine, with one trial with turkeys underway and other planned for testing on adult hens and day-old chicks. Harris said the biggest drawback so far is that the vaccine must be injected, which is logistically complicated in operations involving tens and even hundreds of thousands of birds.

He said he did not know whether the company would ever sell the vaccine directly to producers or whether it would be bought for the government stockpile and distribution.

"Down the road," Harris said, "we can use this license to register the product in foreign countries that have avian flu endemically."

©2015 The New York Times News Service