USDA IMPLEMENTS A NEW STANDARD FOR ANIMAL VACCINE LABELS

The changes at a glance

Single, uniform format

More clearly communicates product performance

Standardized effi cacy and safety summary available online

Simplifi ed data and review requirements

Manufacturers must comply by 2019

In September 2015, the US Department of Agriculture/Animal Plant and Health Inspection Service

(USDA APHIS) introduced an amended Virus-Serum-Toxin Act regulation. The purpose of the change

was to replace the existing multi-tier vaccine label system with a single, uniform format.

WHAT WAS THE REASON FOR CHANGING THE LABEL FORMAT?

The updated requirements for a simpler label claim system are intended to clearly communicate product effectiveness to veterinarians. Instead of the “tiered” label claims that manufacturers

previously have used to describe the level of effi cacy provided, vaccines will now all use the same

labeling claim:

“ This product has been shown to be effective for the vaccination of healthy <insert name of species> <insert number> weeks of age or older against <insert name of disease>.”

The new label format is accompanied by a standardized summary of the effi cacy and safety data, which will be available on a publicly accessible website.

Additionally, removal of the previous 4-tier system aims to simplify the evaluation of effi cacy studies

by APHIS by focusing on a basic claim of effectiveness.

HOW DOES THE LABELING CHANGE AFFECT VETERINARY PROFESSIONALS?

The change should enable a better understanding of product effi cacy and safety and the results of the studies conducted.

Ingelvac Provenza is a trademark of Boehringer Ingelheim Vetmedica GmbH. © 2017 Boehringer Ingelheim Vetmedica GmbH. POR-0257-GEN0417 17460

HOW DID THE PREVIOUS LABEL SYSTEM WORK?

Prior to the change, the packaging and labeling guidelines described effi cacy performance at

4 different levels (tiers) of effectiveness. The guidelines provided examples of label claims across

these 4 tiers that could be used to indicate the expected performance of a product, as supported

by the effi cacy data submitted and approved by the APHIS.

Each label tier required different levels of analysis of the clinical data depending on the claim

being made. For example, if effi cacy data were submitted to support the claim of “prevention

of infection,” the data would have to be analyzed with a high degree of confi dence to determine

that it met the criteria of preventing all colonization or replication of the challenge organism in

vaccinated and challenged animals. In contrast, a claim of “aids in disease control” would only

require that a product is shown to alleviate disease severity or to reduce disease duration.

WHEN IS THE LABELING CHANGE BEING IMPLEMENTED?

The fi nal rule was enacted on September 8, 2015. Biologics manufacturers have 4 years from this date to submit revised labels and a standardized summary of effi cacy and safety data.

To learn more, visit the USDA APHIS website:

https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-biologics/

biologics-regulations-and-guidance/ct_regs_guidance

HOW DOES THE NEW LABEL SYSTEM APPLY TO INGELVAC PROVENZA™?

The Ingelvac Provenza™ label will follow the new label system. The label will not have

a specifi c claim, as would have previously been used (e.g., “prevention of infection”),

but will adapt the simplifi ed wording structure that all new biologics will use.

The indications section of the Ingelvac Provenza™ label will read as follows:

This product has been shown to be effective for the vaccination of healthy pigs 1 day of age or older against influenza virus strains H1N2 and H3N2. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.