Regulatory Brief

 Labeling of Equine Influenza and Swine Influenza Vaccines


Formal title: USDA Center for Veterinary Biologics Notice Draft No. 313


Brief Description:

The USDA Center for Veterinary Biologics released a draft notice notifying veterinary biologics licensees, permittees, and applicants of a change in labeling of veterinary biologics containing swine influenza virus or equine influenza virus. The notice does not pertain to autogenous products containing equine and/or swine influenza virus.

The changes would require labels to contain information regarding the subtypes and strains, or the parent strain of recombinant/resortant/subunit products.

AVMA Response:

It is the opinion of the AVMA that the proposal will likely enhance effective vaccination strategies for currently circulating influenza viruses in swine and horses.

Background Documents:

View AVMA response to USDA (PDF)

View Center for Veterinary Biologics notice draft No. 313 (PDF)

Status:

AVMA responded on August 6, 2007.