The USDA’s Animal and Plant Health Inspection Service (APHIS), in its efforts to prepare for the potential return of highly pathogenic avian influenza (HPAI), is issuing its second request for proposals (RFP) for vaccine manufacturers with the interest and capability to supply a variety of Eurasian H5 (EA H5) vaccines in sufficient numbers to add to the emergency stockpile.
APHIS has not approved the use of vaccine to respond to HPAI to date; however, the Agency is preparing to ensure that vaccine is available should the decision be made to use it. 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. In response to the first RFP issued in August, APHIS awarded contracts for doses of two vaccines for the EA H5 virus strain, which became part of the National Veterinary Stockpile. Those approved contracts were awarded to Ceva and Harrisvaccines.
Vaccines will be carefully evaluated on a number of factors including their efficacy against EA H5 viruses, and products must meet all of APHIS’ safety, potency, and purity standards. All eligible products to be considered must be either conditionally or fully licensed or permitted at the time of submission. Vaccine manufacturers will be evaluated on their ability to produce such vaccines in a timely manner in adequate numbers to meet the needs of the response.
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.