USDA requests more proposals for avian flu vaccines

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.

Avian flu vaccine gets USDA conditional license

Harrisvaccines has been granted USDA conditional licensure of the company’s avian influenza vaccine, RNA, the company announced on September 21. This is the first conditional license for highly pathogenic avian influenza (HPAI) granted since the North American outbreak began in 2015.
The USDA generally grants conditional licenses in order to meet an emergency or unmet need. A conditionally licensed product must show a reasonable expectation of efficacy, safety, and potency.
When H5 avian influenza was confirmed in the spring of 2015, Harrisvaccines, an Iowa-based vaccine producer,  applied its rapid response technology to bring a solution to Iowa and Midwest poultry and egg producers, according to Joel Harris, vice president of Harrisvaccines.
The conditional use permit does not authorize the company to sell the vaccine today, but it does put the company in a better position to apply the vaccine in the case that avian influenza should reemerge in the United States, Harris added.

About the RNA vaccine

The RNA vaccine utilizes the rapid response, SirraVax  platform technology, the company stated. This technology allows for the vaccine to be easily updated to match current and future strains of avian influenza. This is an important first step in implementing a vaccine strategy by the USDA.  Initially, however, producers will have to wait for USDA authorization before acquiring the vaccine. The USDA has called for a solicitation to create a vaccine stockpile for H5 avian influenza for the fall; Harrisvaccines is currently pursuing this opportunity.
“The creation, testing, and regulatory approval of the vaccine was a real joint effort by the USDA’s Agriculture Research Service, the Center for Veterinary Biologics, and Harrisvaccines,” said Dr. Mark Mogler, head of Research and Development at Harrisvaccines. “The ARS’ Southeast Poultry Research Laboratory provided both the gene needed to prepare the vaccine at Harrisvaccines and the proper facilities for efficacy testing in chickens.”
“The threat posed by avian influenza is extraordinary to both producers and consumers,” said Dr. Hank Harris, Founder and CEO of Harrisvaccines. “Getting a vaccine in the field that matches 100 percent to the H5N2 strain is crucial to ongoing containment efforts. This vaccine is also compatible with diagnostic tests that can differentiate infected from vaccinated birds (DIVA). This makes our vaccine an important tool for eradication efforts and may alleviate any concerns with trading partners abroad.”
According to Jodi French, head of manufacturing and USDA liaison for Harrisvaccines, USDA testing of the company’s avian influenza vaccine provided both the efficacy and safety data necessary for approval by the USDA Center for Veterinary Biologics. Further efficacy and potency studies in chickens and turkeys are ongoing, French added.

Egg company impacted by avian influenza encouraged by licensure

The USDA's decision to issue the conditional approval to RNA vaccine is encouraging to Rembrandt Enterprises, which lost more than half of its layer flock as a result of avian influenza.
"I am encouraged to see a new and promising vaccine receive USDA licensure," said Dave Rettig, CEO of Rembrandt Enterprises. "The impact of avian influenza on the layer industry in Iowa has been devastating. We need to continue moving toward long-term solutions which include a vaccine strategy that can be mobilized quickly and tailored to the virus strains impacting our farms."

USDA moves closer to approval of avian flu vaccine

A vaccine that tested 100 percent effective in treating chickens for avian influenza has been developed, U.S. Agriculture Secretary Tom Vilsack said. 
A vaccine has been developed that tested 100 percent effective in protecting chickens from H5N2 avian influenza, U.S. Agriculture Secretary Tom Vilsack told the House Agriculture Committee during a hearing on July 22. Testing is also being conducted on its effectiveness for vaccinating turkeys from the virus, Vilsack said.
Should the avian influenza vaccine prove effective with turkeys, the USDA would like to get it licensed for widespread production and will seek funding from the federal Office of Management and Budget to create a nationwide supply of the vaccine, according to a WANE report.
“Hopefully we’ll be able to get a lot of folks working collaboratively together and we stockpile enough so that if this does hit and hits us hard we’re in a position to respond quickly,” Vilsack said.
Vilsack’s comments follow an announcement made on June 3 from the USDA, stating that it was not ready to approve the use of avian influenza vaccines as the efficacy of vaccine options available at the time was not sufficient. However, the agency did state that it would continue to work with researchers and vaccine companies as they continue to develop other vaccine options.
According to industry sources, some poultry producers, primarily in the egg and turkey industries, have been asking for approval from the USDA to use avian influenza vaccines as part of their eradication efforts.
However, others do not favor a vaccination program because of possible implications on trade.
Jim Sumner, president of the USA Poultry & Egg Export Council (USAPEEC), told the Associated Press that many countries have a strict policy of refusing to accept meat from countries where a vaccine is used because it can be difficult to discern through testing whether birds were infected with an active virus or were vaccinated.