U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum 800.85 

 

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An Equal Opportunity Provider and Employer

Avian Influenza Vaccine

1. Purpose and Background 

This memorandum informs all interested parties of the conditions under which the 

Center for Veterinary Biologics (CVB) considers license applications for avian influenza 

vaccines. This information supplements the applicable Standard Requirements found in 

title 9, Code of Federal Regulations (9 CFR), parts 113.200 and 113.300.

USDA, APHIS, VS considers avian influenza (AI) in chickens an exotic disease and regulates 

the production and use of vaccine according to guidelines specified in VS Guidance 

8605.1. Permits issued pursuant to 9 CFR 122.2 regulate the importation and/or 

interstate shipment of AI viruses.

This memorandum represents the Agency’s position on this topic. It does not create or 

confer any rights for or on any person and does not bind the U.S. Department of 

Agriculture (USDA) or the public. The information it contains may be made available to 

the public. While this document provides guidance for external users, VS employees may 

not deviate from the directions provided herein without appropriate justification and 

supervisory concurrence.

Pursuant to the Congressional Review Act (5 U.S.C. § 801 et seq.), the Office of 

Information and Regulatory Affairs designated this rule as a non-major rule, as defined by 

5 U.S.C. § 804(2).

2. Document Status 

 

A. Issue date: 08/07/2020

B. This document replaces Veterinary Services Memorandum 800.85 dated 

May 18, 2006, which is cancelled. 

3. Authorities and References 

 

A. Authorities (Code of Federal Regulations (CFR)):

• 7 CFR 371.4

• 9 CFR part 102

• 9 CFR part 113

• 9 CFR part 122
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum 800.85 

 

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An Equal Opportunity Provider and Employer

B. References

• VS Guidance 8605.1, Animal and Plant Health Inspection Service Policy on H5 and 

H7 Avian Influenza

4. Audience 

VS employees and members of industry

5. Guidance 

 

A. Product Master Seed Viruses (MSVs) 

 

1. Licensees and applicants (firms) must meet all applicable Standard Requirements 

for MSVs, prescribed in 9 CFR 113.200 and 113.300, with the following additional 

considerations:

a. Interstate Movement – VS regulates all importations or interstate movements 

of AI viruses by permit, under 9 CFR 122.2, with the exception of Master 

Seeds approved by CVB, which require CVB approval for movement.

b. Conventional Killed Vaccines – VS does consider licensing conventional killed 

AI vaccines provided that firms obtain and use the MSVs under the following 

conditions:

i. Acceptable MSVs – Firms must only use AI viruses of low pathogenicity 

obtained from the Diagnostic Virology Laboratory of the National 

Veterinary Services Laboratories (NVSL), to produce MSVs for

conventional killed vaccines. Firms may obtain any hemagglutinin (H) 

type from this source.

ii. VS Organisms and Vectors (OV) Permit Required – Firms must apply for 

an OV permit to obtain AI isolates; typically, a biosecurity inspection is 

required before issuing such permit. OV will issue permits for AI 

isolates with the restriction that use of the isolate is limited to in vitro

studies. AI isolates may be used to produce and test vaccines only 

when APHIS so authorizes.

c. Recombinant Derived Vaccines – APHIS does consider licensing live or 

inactivated recombinant vaccines, subunit vaccines, or other biotechnologyderived AI vaccines produced from recombinant-derived MSVs. Firms must
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum 800.85 

 

3 | Page

An Equal Opportunity Provider and Employer

obtain an OV permit to acquire the AI viruses necessary to construct such 

MSVs.

d. Conventional Modified Live Vaccines – Due to the high rate of mutation 

documented for AI viruses, APHIS does not consider license applications for 

conventional modified live AI vaccines.

B. Product Development 

 

1. Firms must meet all applicable Standard Requirements for licensure including, but 

not limited to, 9 CFR 113.200 and 113.300, with the following additional 

considerations:

 

a. Product Claims – Firms may develop products with a claim for use in either 

chickens or turkeys for any H type. Firms must support all claims for each 

species, each H type, each age, and route of administration with appropriate 

data.

b. Challenge Studies Involving Licensed Product – Firms must support 

applications for regularly licensed products with appropriate vaccinationchallenge efficacy data. Conduct challenge studies using highly pathogenic 

avian influenza virus in support of an application for licensure under biosafety 

level 3 containment conditions. Regardless of the challenge strain used, firms 

must obtain CVB approval of the laboratory, study protocol, and challenge 

virus before initiating the study.

c. Conditional Licensing – APHIS only considers applications for conditionally 

licensed products that meet the conditions found in 9 CFR 102.6. 

Furthermore, all applicants or licensees seeking or holding conditional licenses 

for AI vaccines must work toward eventual regular licensure of these 

products.

C. Product License Restrictions 

 

1. A. General License Restrictions – APHIS adds the following restrictions to all 

licenses issued for AI vaccines:

a. Distribution in Each State – “Distribution in each State shall be limited to 

authorized recipients designated by proper State officials – under such 

additional conditions as these authorities may require.”
U.S. DEPARTMENT OF AGRICULTURE 

Marketing and Regulatory Programs

Animal and Plant Health Inspection Service

Veterinary Services 

VS Memorandum 800.85 

 

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An Equal Opportunity Provider and Employer

b. Distribution for Export – “Export distribution shall be limited to authorized 

recipients designated by proper animal health regulatory officials – under 

such additional conditions as these authorities may require.”

2. Additional License Restrictions – APHIS also adds the following additional 

restrictions to licenses issued for all AI vaccines for use in chickens, as well as for 

all H5 and H7 AI vaccines for use in turkeys: “Domestic distribution and use shall 

be under the supervision or control of USDA, APHIS, VS, as part of an official USDA 

animal disease control program.”

D. Product Labeling

1. Limited Species Recommendations – Because of the license restrictions on 

distribution and use, individual product labels may recommend use of the product

in chickens or turkeys, but not both.

2. Distribution Statement – For licenses carrying the restriction listed in C.1 above, 

the domestic product labels must carry the following statement: “This product 

may only be distributed and used as part of an official USDA animal disease 

control program.”

3. Indication of Types – Product labels must indicate the H and N type of the AI virus 

used to produce the product.

E. Implementation/Applicability

Updated policy in this memorandum is effective immediately.