Dec 3, 2015
The US agricultural agency is continuing to prepare for the potential return of highly pathogenic avian influenza (HPAI) by issuing its second request for proposals (RFP) for vaccine manufacturers.
The United States Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) is seeking manufacturers which have the interest and capability to supply a variety of EA H5 vaccines in sufficient numbers to add to the emergency stockpile.
Ensuring HPAI vaccines are available
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 Eurasian H5 (EA H5) virus strain, which became part of the National Veterinary Stockpile. These contracts were awarded to Ceva and Harrisvaccines.
Efficacy of vaccines
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.
Dosage per bird
Nationally, the placement rate of laying hens and meat turkeys is approximately 20 million birds per month. With each bird requiring two doses of vaccine prior to placement, 80 million doses per month will be needed just for these two sectors alone. Therefore, vaccine companies should minimally have a production capacity ≥ 100 million doses per month to address these two sectors.