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Understanding Claims On Vaccine Labels

published: August 8th 2008
by: Soren Rodning, extension veterinary
source: Alabama Cooperative Extension Service

A successful herd health program involves proper herd immunization (vaccination) to prevent and/or control a variety of infectious diseases. However, selecting the proper vaccines for your herd can be a difficult task considering the large number of vaccines that are available. These are some things to consider when developing a vaccination program for your herd:
1) determining the goals of your vaccination program (e.g., what
diseases do you want to prevent and/or control, and in what type/age animal?); 2) discussing these goals with your veterinarian and/or Extension agent; and 3) understanding a vaccine’s expected level of protection.
Every vaccine bottle or product insert has information
related to its expected level of protection. The U.S. Department
of Agriculture can grant one of five possible levels of protection
based on a thorough analysis of supporting efficacy and safety
data. The following are the five levels of protection in order from
greatest protection to least protection:
1. Prevention of infection
2. Prevention of disease
3. Aid in disease prevention
4. Aid in disease control
5. Other claims
The Center for Veterinary Biologics, which is part of the Animal and Plant Health Inspection Service (APHIS) of the USDA, is the agency that evaluates vaccines and recommends the appropriate label protection claims. Vaccine manufacturers may voluntarily choose a lesser label protection claim, but they cannot increase their label claims without the supporting data.
Understanding label claims is therefore one way to evaluate the expected efficacy of a vaccine, but remember that these claims only apply when products are administered according to label directions. So what do these levels of protection mean?
Prevention of Infection
Prevents all colonization or replication of the challenge  organism. A claim that it is intended to prevent infection may be made only for products able to prevent all colonization or replication of the challenge 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. This claim is rarely granted. Prevention of Disease
Highly effective in preventing clinical disease.
A claim that it is intended to prevent disease may be made only for products shown to be highly effective in preventing clinical disease in vaccinated and challenged animals. If so, a label statement such as "for the prevention of disease due to [specific microorganism]" may be used.
Aid in Disease Prevention
Aids in preventing disease by a clinically significant amount. A claim that it is intended to aid in disease prevention may be made for products shown to prevent disease in vaccinated and challenged animals by a clinically significant amount which may be less than that 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
Aids in the reduction of disease severity, duration or onset. A claim that it is intended to aid in disease control may be made for products which have been 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.
Deciding when to calve can only be determined after considering all of the resources and goals of each particular cattle operation. Fall calving allows the weaned calves to be marketed during seasonally high prices (i.e., August), but requires a large amount of winter feed for the lactating cow. On the other hand a spring calving season reduces winter feed costs but results in marketing of the weaned calves in a seasonally low price market (i.e., October). Additionally, if the ability to background or stocker the calves exists then this can also influence the decision-making process. The best recommendation is to not calve during the summer months. For most producers on a year-round calving season the most feasible way to convert to a 90-day calving season is to do it over a 3-year period. During the first year, leave the bull with the cows for 6 months, reduce it to 4 1/2 months the second year and then to 90 days the third year. The most important point of accomplishing this is to have a well-fenced bull pasture. One strand of barbed wire and some privet hedge will not keep a bull away from cows that are in heat! For a small producer, it may be feasible to lease a bull from someone; this would certainly be a viable option for many producers. A defined calving season makes management of a beef herd much easier. It results in providing better overall nutrition to the herd. It increases the likelihood of detecting calving problems in a timely manner. It also results in a more uniform calf crop, which will bring an increased price at the marketplace. The key to having a controlled calving season is to have control of the bulls. This requires a well-fenced bull pasture or pen.