The USDA’s Animal and Plant Health Inspection Service (APHIS) on October 13 awarded contracts to Harrisvaccines and Ceva to manufacture doses of avian influenza vaccine. 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 (HPAI).

While APHIS has not approved the use of vaccine to respond to HPAI, the agency is preparing to ensure that vaccine is available should the decision be made to use it during a future outbreak. 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.

Earlier in the year, APHIS issued a request for proposals (RFP) for vaccine manufacturers with the interest and capability to supply a variety of Eurasian (EA) H5 vaccines in sufficient numbers to establish the emergency stockpile. As part of the award, companies must:

  • Manufacture the number of vaccine doses outlined in their contract, and store those doses up to 5 years
  • Deliver the finished vaccine anywhere in the country within 10 days of a request for doses from the National Veterinary Stockpile
  • Test the vaccine regularly to ensure continued potency
  • Provide information and testing results with APHIS upon request

The HPAI vaccines covered by this award carry either conditional or full licenses from APHIS’ Center for Veterinary Biologics, and were carefully evaluated on a number of factors, including their efficacy against EA H5 viruses.  

Companies respond to earning contracts with APHIS

The Harrisvaccines product is the RNA particle vaccine, while Ceva's product is called Vectormune AI

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“The Harrisvaccines team is honored to assist the 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 our poultry and egg producers against another overwhelming loss. Harrisvaccines is proud to be a part of that effort.”

The USDA has requested that Harrisvaccines provide a total of 48 million doses, 25 million of which will be provided within 45 days, the company stated.

Ceva, in a press release, stated it had studied the evolution of the avian influenza virus and the increasing difficulty countries and regions have had in containing its spread. Ceva's avian influenza vaccines are used in other geographical areas throughout the world.

"We hope the U.S. poultry producers do not have to suffer through a avian influenza outbreak this fall or during 2016," said Dr. Kristi Moore Dorsey, Ceva vice president of research and development. "As part of the USDA vaccine stockpile, vaccine will be available for use by USDA if they decide to mandate vaccination."

APHIS continues to issue RFPs for avian flu vaccines

Although no decision has been made to use vaccine in the event of a future HPAI outbreak, APHIS will continue to issue RFPs for vaccine manufacturers on a quarterly basis through September 2016, to allow additional products to be developed and considered for the stockpile should an HPAI outbreak occur. Information about future RFPs and awards will be available on the APHIS website.