APHIS Environmental Assessment of HPAI Vaccine Finds No Impact

Written by Katharine Richter

On October 7, 2015, Animal and Plant Health Inspection Service (APHIS) issued a notice of the environmental assessment (EA) of Avian Influenza H5 vaccines has been prepared.  The notice stated that “based on the environmental assessment . . . use of vaccines . . . will have no significant impact on the human environment.”

The notice states that “under the Virus-Serum-Toxin Act (21 U.S.C. 151 et. seq.), APHIS is authorized to promulgate regulations designed to ensure that veterinary biological products are pure, safe, potent, and efficacious.”  The notice highlights the December 2014 outbreak of highly pathogenic avian influenza (HPAI) and the devastating affects it had on the poultry industry.  The hardest hit sectors of the poultry industry was commercial meat turkeys and laying hens, with the total loss of “over 48 million birds between December 2014 and June 2015.”    

APHIS states that after the comment period closes, if the comments raise issues not previously considered, APHIS will issue a supplement to the EA.  Given that timeliness is so crucial with the cold weather setting back in, APHIS is aiming to authorize shipment and field use of the vaccine as quickly as possible, potentially before the close of the comment period.

The public comment period regarding the environmental assessment will be open until November 6, 2015. 

First Avian Influenza Vaccine Granted Conditional License

Written by Tyler R. Etter

On September 21, 2015, an Ames, Iowa vaccine producer, Harrisvaccines, announced that the United States Department of Agriculture (USDA) granted a conditional license to the producer’s Avian Influenza vaccine. This vaccine is the first Highly Pathogenic Avian Influenza (HPAI) vaccine to receive a conditional license since the outbreak began last spring.

The vaccine utilizes SirraVax technology, which will allow for rapid updates to current and future strains of HPAI. This technology is a critical step for the implementation of any vaccine strategy. It is important to note that the USDA must first grant its authorization before the vaccine can be distributed to producers. The USDA is currently seeking to create a stockpile of vaccines in the event of an outbreak this fall.

Although many producers will welcome a vaccine if offered, there are concerns by broiler producers about the impacts on export markets if a vaccine is used. However, the CEO of Harrisvaccines, Frank Harris, believes the vaccine will be an essential tool for eradication efforts that may alleviate the concerns of foreign trading partners.

A conditional license is usually granted in the event of an emergency or to address an unmet need. Such a product must show a reasonable expectation of efficacy, safety, and potency. Further testing is ongoing. Harrisvaccines has received USDA licensure in the past for Porcine Epidemic Diarrhea Vaccine, RNA (June 2014), Swine Influenza Vaccine, RNA (September 2012), and Autogenous Vaccine, RNA for Rotavirus C (January 2013).

Vilsack Testifies Regarding Bird Flu Vaccine

On July 22, 2015, U.S. Agriculture Secretary Tom Vilsack testified before the U.S. House Committee on Agriculture and addressed the United States Department of Agriculture’s (USDA) latest efforts regarding Highly Pathogenic Avian Influenza (HPAI). 

At the hearing, Vilsack stated that USDA was working to produce a vaccine to combat the spread of HPAI.  According to the Secretary, a seed strain vaccination has been developed, and the vaccine has proven to be 100% effective when tested on chickens.  Though Vilsack did not provide a timeline for the availability, he did state that the vaccine was currently being tested on turkeys and if proven effective, would hopefully be ready for production in the near future. 

Relatedly, the Secretary stated that USDA was working on efforts to ensure that U.S. trading partners would not penalize future exports if a vaccine is employed.  Vilsack suggested that any foreign ban on U.S. poultry products could be limited regionally (where the vaccine is used) and not nationally.

To view Secretary Vilsack’s testimony, please click here.

 

Written by M. Sean High - Staff Attorney

July 22, 2015

Senator Argues USDA Funds Needed for Avian Flu Outbreak

  On June 22, 2015, Senator Charles Schumer (D-NY) urged Congress to not cut $500 million in funding from USDA programs.  Schumer argued the funding should be used to help manage the current avian flu outbreak and could be used for vaccination efforts, “biosecurity” measures, as well as research costs to discover more on how the virus is transmitted.

  According to the press release in the Senator’s website, the impact on consumers and retailers is already being felt and only expected to rise.  The press release stated egg prices have increased to record levels.  In New York, the average wholesale price for a dozen eggs ranges from $1.60-$1.66, beating the 2014 record of $1.42.  “Breaker” eggs used by restaurants and other food producers have increased in price by 273%, causing companies to seek alternative ingredients in response to the decreasing supply. 

   According to the USDA website, as of June 17, 2015, 48,091,293 birds have been affected by Avian Influenza.  Of the total birds affected, approximately 80% are egg laying hens, nationwide that accounts for 10% of the egg laying population.

    The Fiscal Year 2016 Agriculture Appropriations Bill was approved by the House Appropriations Subcommittee on June 17.  It was set to be considered by the full committee on June 25 but was postponed.

Written by Katharine Richter - Research Assistant

June 30, 2015