Look to the Label - USDA Provides Valuable Insight on a Vaccine’s Expected Level of Protection

NEW YORK (Nov. 2, 2009) — In building a vaccination protocol, you must—at some point—determine what products will best match your needs. One way to distinguish the many vaccine options on the market is to look at the vaccine labels and the expected U.S. Department of Agriculture (USDA) levels of protection.

“After examining the risks confronting your operation, such as what potential disease pressures you face, a producer must identify a proper strategy to manage those risks, including vaccinations,” said Doug Braun, DVM, Pfizer Animal Health veterinarian. “The beauty of the USDA label claims is that they are an unbiased source that offers clear information of the level of expected protection.”

The USDA offers one of five possible label claims with increasing levels of expectation to indicate a product's level of protection against a particular disease pressure.

1. Prevention of infection: Prevents all colonization or replication of the challenge organism.

2. Prevention of disease: Highly effective in preventing clinical disease.

3. Aid in disease prevention: Aids in preventing disease by a clinically significant amount.

4. Aid in disease control: Aids in reduction of disease severity, duration or onset.

5. Other claims: Products with beneficial effects other than direct disease control.

“A product with the ‘prevention of infection’ or ‘prevention of disease’ indicates a more robust label claim,” Braun said. “Most available products have an ‘aids in disease prevention’ label claim.”

Unbiased Review

The Center for Veterinary Biologicals (CVB), which is part of the Animal and Plant Health Inspection Service (APHIS) of the USDA, conducts the evaluation. The CVB is the government agency that reviews and grants licenses for veterinary vaccines.

To determine a product’s label claim, CVB looks at each manufacturers specific research and safety data. In each instance, data must fully support label indications and accurately reflect the expected performance of the product.

How the CVB grants a license:• Evaluates the supportive efficacy and safety data supplied by the vaccine manufacturer and decides whether or not the vaccine can be licensed.

• Determines what type of efficacy claim can appear on vaccine labels and in advertising and promotional materials.

• Companies may voluntarily choose a lesser label indication; however, they cannot increase the level of the claims above what the filed USDA data supports.

Where to Find Label Claims

The best way to find out what label indication applies to a particular vaccine is to read the label closely. Claim information is usually found on the product package or package insert. Other locations to find information on CVB label claims are the USDA web site or by asking your veterinarian.

Pfizer Animal Health, a business of Pfizer Inc (NYSE: PFE), is a world leader in discovering and developing innovative animal prescription medicines and vaccines, investing an estimated $300 million annually. Beyond the U.S., Pfizer Animal Health also supports veterinarians and their customers in more than 60 countries around the world. For more information on how Pfizer works to ensure a safe, sustainable global food supply with healthy livestock and poultry, or how Pfizer helps companion animals and horses to live longer, healthier lives, visit www.PfizerAnimalHealth.com.

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