CENTER FOR VETERINARY BIOLOGICS DRAFT NOTICE NO. 22-02

TO: Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

FROM: Byron Rippke

Director

SUBJECT: Availability of Avian Influenza Isolate and Sequence Information

I. PURPOSE

The purpose of this notice is to direct interested parties to the genetic sequences 

from the recent Eurasian clade 2.3.4.4b H5N1 highly pathogenic avian influenza 

(HPAI) virus isolated from commercial turkeys from Indiana in February 2022. The 

notice is also to inform interested parties that the HPAI isolate will be available for 

purchase from the National Veterinary Services Laboratories (NVSL) by March 

2022.

II. BACKGROUND

In late December 2021, H5N1 clade 2.3.4.4b was identified as the cause of die-offs 

in domestic birds in Newfoundland. The virus was found to be highly similar to 

viruses causing ongoing outbreaks in Europe. In January 2022, the United States 

reported similar viruses from wild bird surveillance along the Atlantic flyway. On 

February 9, 2022, the USDA announced the first detection in commercial poultry in 

Indiana. This is the first detection of Eurasian H5 clade 2.3.4.4 in poultry in the 

United States since 2015, and the first report of HPAI in poultry since 2020.

Further information on the poultry finding is available at USDA APHIS | USDA

Confirms Highly Pathogenic Avian Influenza in a Commercial Turkey Flock in

Dubois County, Indiana

Further information on wild bird findings is available at USDA APHIS | 2022

Highly Pathogenic Avian Influenza

III. ACTION (or POLICY)

Veterinary Services is making the HPAI genomic sequence, as well as the HPAI 

virus, courtesy of the Indiana Board of Animal Health and the Indiana Animal 

Disease Diagnostic Laboratory, available to facilities to encourage disease research 

and development to benefit the U.S. poultry industry. The complete genomic 

Animal and Plant

Health Inspection

Service

Veterinary Services

Center for Veterinary 

Biologics

1920 Dayton Avenue

PO Box 844

Ames, IA 50010

(515) 337-6100
CENTER FOR VETERINARY BIOLOGICS DRAFT NOTICE NO. 22-02

Page 2

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sequence has been submitted to GISAID as Isolate ID EPI_ISL_9909371 for 

A/turkey/Indiana/22-003707-003/2022.

Available isolate:

• A/turkey/Indiana/22-003707-003/2022 – courtesy of the Indiana Board of 

Animal Health and the Indiana Animal Disease Diagnostic Laboratory.

Biologics firms that wish to obtain samples of these isolates for research purposes should:

A. Contact the NVSL Diagnostic Virology Laboratory at (515) 337-7551 for 

guidance regarding the appropriate forms and payments to submit.

B. Submit the completed forms and the payment associated with the order by one of 

the following methods:

1. Mail: NVSL User Fees, Box 844, Ames, Iowa 50010

2. Email: NVSL_concerns@usda.gov. NVSL will inform customers when the 

virus is ready to ship.

C. Note that the HPAI isolate must be transferred in compliance with the 

Select Agent Regulations. No Material Transfer Agreement will be required. 

This isolate is not a Master Seed; it is being made available for research and 

development. The availability of this isolate does not infer any impending 

change in vaccination policy.

IV. IMPLEMENTATION/ APPLICABILITY

The HPAI sequence referenced in this announcement and the referenced reagent will be 

available from NVSL no later than March 1, 2022.