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Understanding Vaccine Labels
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Vaccines are an essential tool for aiding in the prevention and control of infectious diseases in livestock. There are hundreds of vaccines and vaccine combinations available for livestock producers. Selecting and using the right vaccines is an essential part of any successful livestock operation.
With all the choices available, it's important to understand the labelling guidelines.
There are 5 possible levels of protection:
- Prevention of infection
- Prevention of disease
- Aid in disease prevention
- Aid in disease control
- Other claims
In each instance, data generated by the vaccine manufacturer must fully support label indications and accurately reflect the expected performance of the product.
In deciding on a vaccine program for your livestock, consult with a veterinarian, who can help you choose the most effective products and develop the best program for your operation. We also encourage you to read vaccine labels and become knowledgeable on what they are indicated for and what their limits are.
Prevention of Infection
Approved for products able to prevent all colonization or replication of the challenged organism in vaccinated and challenged animals. If such a conclusion is supported with a very high degree of confidence by convincing data, a label statement such as, “for the prevention of infection with (specific microorganism),” may be used.
Prevention of Disease
Allowed only for products shown to be highly effective in preventing clinical disease in vaccinated and challenged animals. The entire interval (95%) estimate of efficacy must be at least 80%. If so, a label statement such as, “for the prevention of disease due to (specific microorganism),” may be used.
Aid in Disease Prevention
Allowed on products shown to prevent disease in vaccinated and challenged animals by a clinically significant amount that may be less than required to support a claim of disease prevention (see above). If so, a label statement such as, “as an aid in the prevention of disease due to (specific microorganism),” may be used.
Aid in Disease Control
Claim exclusive to products shown to alleviate disease severity, reduce disease duration or delay disease onset. If so, a label statement such as, “as an aid in the control of disease due to (specific microorganism),” or a similar one stating the product's particular action, may be used.
Other Claims
Products with beneficial effects other than direct disease control, such as the control of infectiousness through the reduction of pathogen shedding, may make such claims if the size of the effect is clinically significant and well-supported by the data.
A label is a piece of information printed on the outside of the vaccine bottle. This same information is also on a printed piece of paper that comes in the box containing the bottle. The label contains instructions for administering the vaccines and other key information.
The three most important sections of the label are “indications,” “directions” and “precautions.”
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