Regulatory Brief

 Comments on USDA CVB Draft Notice No. 327


Formal title: USDA Center for Veterinary Biologics Draft Notice Number 327 - Studies to Support Label Claims Regarding Revaccination Interval Recommendations

Brief Description:

The United States Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) released Draft Notice No. 327 – Studies to Support Label Claims Regarding Revaccination Interval Recommendations – in order to ensure that revaccination intervals currently recommended on vaccine labels are supported by manufacturer efficacy data on vaccine fractions (antigens, antibodies, antitoxins, and/or other components) licensed after 1994, and all rabies virus vaccines per Title 9, Code of Federal Regulations (9 CFR), Parts 113.209, and 113.312.

Draft Notice No. 327 states that studies supporting revaccination intervals should include the following:

  • Animals of the minimum age listed on the label
  • Same potency of the biologic used in original efficacy studies
  • Diligence to ensure non-exposure to virus of interest during interval between vaccination and challenge
  • Consideration of appropriate animal age for establishment of revaccination interval which may or may not coincide with age of onset of immunity

AVMA Response:

The AVMA commends the USDA CVB on its Draft Notice No. 327 - Studies to support Label Claims Regarding Revaccination Interval Recommendations. The AVMA has repeatedly stated the need for scientifically robust efficacy data to support vaccine label statements regarding revaccination intervals.

The AVMA supports the USDA CVB's recommendation that labels bear statements such as "Immunity demonstrated at X weeks after last vaccination" because vaccine labels should provide veterinarians with factual information backed by scientific findings. Furthermore, the AVMA supports the USDA CVB's requirement for label language to state that revaccination intervals have not been established – when applicable. Availability of such accurate, transparent information will allow veterinarians to use available scientific information to tailor a specific revaccination regimen for individual animals, without preconceptions that revaccinations should occur every Y years.

The AVMA lauds the USDA's progress in enhancing biologic label transparency and accuracy. The AVMA encourages the USDA to continue its momentum to modernize animal biologics labels.

Background Information:

CVB Draft Notice No. 327 - Studies to Support Label Claims Regarding Revaccination Interval Recommendations.

The AVMA responded on August 9, 2010