An Iowa-based vaccine producer, Harrisvaccines, last week announced it has been awarded a contract to provide Avian Influenza H5 vaccine to USDA's Animal and Plant Health Inspection Service.
This action is being taken to develop the agency's National Veterinary Stockpile, and does not signal a decision to vaccinate for highly pathogenic avian influenza.
The total amount of the award is $6 million and fulfillment of the contract will span two years. USDA has requested that Harrisvaccines provide a total of 48 million doses, 25 million of which will be provided within 45 days.
Another company, Ceva Corporation based in France also was awarded a $6 million contract to manufacture its vaccine.
"The Harrisvaccines team is honored to assist USDA in the continued fight against avian influenza," said Dr. Hank Harris, founder and CEO of Harrisvaccines. "By stockpiling our pioneering RNA particle vaccine, the U.S. is taking an important first step in protecting poultry and egg producers against another overwhelming loss. Harrisvaccines is proud to be a part of that effort."
Avian flu devastated U.S. poultry producers earlier this year
Avian influenza is a fast-moving, highly contagious disease that has devastated producers this year. To date, nearly 50 million chickens and turkeys have been lost to the virus.
The formation of an H5 vaccine stockpile is a crucial step toward protecting our nation from the resurgence of the deadly virus, Harris says.
Harrisvaccines received a USDA conditional license for Avian Influenza Vaccine, RNA, in September 2015. This was the first conditional license for highly pathogenic avian influenza granted since the outbreak began in spring 2015. Harrisvaccines creates Avian Influenza Vaccine, RNA by using its rapid response, SirraVax platform technology, and all efficacy studies for the license were completed by USDA entities.
The vaccine can be produced in about four weeks, does not require a live virus for production, and is fully DIVA-compliant. DIVA stands for differentiating infected animals from vaccinated animals, and compliance indicates that animals will not test positive for the HPAI virus simply because they were vaccinated.
This is an important factor to consider when eradicating a disease and evaluating international trade implications of vaccine use in the U.S. poultry industry.
Vaccine stockpile is designed to provide a base of protection
"Our SirraVax RNA technology gives us the ability to match any virus or bacterial strain 100%, and to continue to update the vaccine to match any additional strains of the agent that may emerge in the future," said Joel Harris, vice president of Harrisvaccines. "This stockpile could provide the poultry industry a base of protection against the next H5 HPAI outbreak, and Harrisvaccines is in a position to rapidly produce additional vaccines if the virus changes or a new strain emerges."
Harrisvaccines has already begun production of Avian Influenza Vaccine, RNA in its USDA-approved production facility in Ames, Iowa.
When the bird flu virus hit last spring, about 40% of Iowa's laying hens were lost. Iowa is the nation's largest egg producer. State and federal regulators are watching closely to see if the virus reappears this fall as wild ducks and geese migrate for the winter. Researchers say the virus spreads from the droppings of wild birds, but "lapses" in biosecurity by workers, such as failing to sanitize boots or equipment, contributed to the outbreak.
Companies are only allowed to sell their vaccines to USDA
USDA told drug companies in August it was interested in stockpiling as many as 500 million doses of one or more vaccines. USDA said the companies must be able to make the vaccine quickly, with delivery within 10 days of the order, and store the doses as long as five years.
The companies are allowed to sell their vaccines only to USDA, and can't distribute them to poultry producers to use. The decision to stockpile the vaccine does not mean USDA has decided to vaccinate chickens and other birds for the deadly bird flu virus.
"While APHIS hasn't approved the use of vaccine to respond to avian flu or HPAI, the agency is preparing to ensure that vaccine is available should the decision be made to use it during a future outbreak," an APHIS official said. "Any decision to use vaccination in a future HPAI outbreak would require careful consideration of the efficacy of the vaccine, any impacts of using HPAI vaccine in the field, and the potential trade impacts." USDA has said any decision to use a vaccine will be made with state and industry officials to assess the impact it would have on trade.
Broiler chicken producers who depend on trade with other nations have expressed concern that some trading partners could ban U.S. poultry imports if the vaccine is used.
Egg and turkey producers, who are less dependent on exports, have been more open to the vaccine.