Industry groups have pushed for a single-tiered system since 2002. Similar to the system FDA uses for human vaccines, the single-tiered system makes the approval process more efficient, while still providing producers and veterinarians the information they need to make vaccine decisions.
- USDA published a final rule in 2015. USDA released guidelines in 2018, and the single-tiered system now appears on new vaccine labels.
Source: Dairy Herd Management, April 10, 2019. Link. The new system replaces the four tiered system levels with a single claim for efficacy of the product. Sponsors still, however, need to demonstrate product safety, and publish pertinent trial data to secure FDA licensure for a new vaccine.
INSIGHTS: NOTE: Chris Chase, DVM, says the research summaries on the USDA/APHIS website support the label claims for efficacy, and not marketing information, such as head-to-head comparisons of competing vaccines.