APHIS: Preparatory Steps For Stockpiling & Using An HPAI H5 Vaccine

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Although no decision has been made regarding the use of  HPAI H5 vaccines on American poultry flocks, the USDA has been working throughout the summer to help pave the way for their use if needed. In June APHIS announced that Additional Criteria Must Be Met Before HPAI Poultry Vaccines Can Be Approved, and while many in the beleaguered poultry industry are lobbying heavily for them, their use is not without some serious downsides.

 

We looked recently at some of those potential pitfalls in MPR: Poultry AI Vaccines Are Not A `Cure-all’  and  PLoS Bio: Imperfect Poultry Vaccines, Unintended Results, so I’ll not rehash those points today.  .

 

Whether they are ever sanctioned for use, it only makes sense to take those steps necessary to make their rapid rollout possible if they are ultimately required. And so today APHIS has announced two steps they are taking in that regard:

 

1. The issuance of a request for proposals for vaccine doses to equip the National Veterinary Stockpile
2. Notification that APHIS will publish an environmental assessment evaluating the potential environmental impacts of using vaccine in the event of an HPAI outbreak

 

Even assuming a fast track, there are numerous logistical and regulatory hurdles ahead before any AI vaccine could be deployed in this country. So America’s poultry industry will be relying on strict biosecurity - and the quarantining and culling of infected flocks - for the foreseeable future.

 

APHIS to Issue Environmental Assessment and Request for Proposals for Highly Pathogenic Avian Influenza Vaccine

Published: Aug 18, 2015

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August 18, 2015—The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has been preparing for the potential recurrence in the fall of the highly pathogenic avian influenza (HPAI) virus that affected more than 48 million birds at over 200 poultry facilities earlier this year. As part of these preparations, APHIS and its state and industry partners are examining the potential use of vaccine to help prevent illness in birds and interrupt the spread of the disease.  APHIS is today announcing two actions related to vaccine use: the issuance of a request for proposals for vaccine doses to equip the National Veterinary Stockpile, and notification that APHIS will publish an environmental assessment evaluating the potential environmental impacts of using vaccine in the event of an HPAI outbreak.

While APHIS has not approved the use of vaccine to respond to HPAI to date, the Agency is preparing to ensure that vaccine is available should the decision be made to use it. APHIS is seeking to create a stockpile of vaccine for the Eurasian H5 (EA H5) virus strain that circulated in domestic poultry earlier this year.   APHIS issued a request for proposals yesterday for vaccine manufacturers with the interest and capability to supply a variety of EA H5 vaccines in sufficient numbers to establish the emergency stockpile.

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.

The RFP is available here: https://www.fbo.gov/index?s=opportunity&mode=form&id=56f3e86d4538b147c5803c4e335ad9f6&tab=core&_cview=1

In the coming weeks, APHIS will also publish an environmental assessment that examines the impacts of using HPAI vaccine in the field during an outbreak response.  This assessment will look at two alternatives: approving vaccine use targeting EA H5 viruses or taking no action.  Once published, the EA will have a 30-day public comment period.

It is important to note that these actions do not obligate APHIS to purchase vaccines from any companies that respond to the request for proposals and do not imply the Agency has made a decision to use vaccination. A decision to use vaccination would require careful consideration of the efficacy of the vaccine, any impacts of using HPAI vaccine in the field, and the potential trade impacts, and would be made jointly by APHIS and State animal health authorities. Today’s actions are being taken to ensure the Agency and its partners are well-positioned to respond to a future outbreak.