Efficacy Is But One Sign
Of A Quality Vaccine

Manufacturer's testing procedures and independent
regulatory certification of sterility, safety and shelf-life
distinguish product quality.

PHARMAQs aquatic animal vaccines are designed with one primary objective: to protect your business and your crop from the devastating effects of bacterial disease for as long as scientifically possible. The most obvious indication of protection is efficacy On the surface, a measurable reduction in mortality and a subsequent boost in yield would seem to confirm quality in a vaccine. Yet, efficacy is but one component of PHARMAQs quality assurance program.

At PHARMAQ, we believe that a vaccine must be more than potent and efficacious, it must be safe to use, and it must be stable for long periods of time in storage. We carefully monitor every step of the research, development and manufacturing processes to ensure that our products pose no risk of contamination and do not expose your stock to infectious agents.

Our research and development team has spent years analyzing and experimenting with pathogens, media optimization techniques, and stabilization and emulsification technology to attain long-lasting protection and stability in our bacterins.

Once our research team demonstrates that a vaccine is ready for production, a "pilot" batch, or small volume, is produced. Then the testing really begins, because the test serial and every production serial after it must meet rigid standards of PHARMAQ and the United States Department of Agriculture (USDA), both before and after the products are licensed. This includes domestic products, products made exclusively for export, and autogenous products made for special orders.

Export products are often also subject to further regulation by foreign governments.

We test every batch of vaccine on our fish
before you use it on your fish

Our testing process is continuous. When a new product receives a USDA license and production approval, each batch must be tested for sterility before and after final packaging. The USDA not only requires that each product be totally free of any living cells used to prepare the vaccine, it must also be free of any contaminating cells. This requires vigorous testing, because too little use of the sterilizing agent might compromise sterility, and too heavy a use might create problems of toxicity to the intended aquatic animal - or possibly affect efficacy

Tested in the field and in the laboratory

In addition to sterility, every PHARMAQ product is also tested for safety and for acute (immediate) and chronic (long-term) post vaccination mortality, both in the laboratory and in the field.

PHARMAQ conducts field trials of new vaccines at numerous cooperating commercial farms around the world. Hundreds of thousands of fish are involved in these trials, under farm operating conditions and natural disease challenges. The trials are programmed not only to compare acute and chronic mortalities under various handling, environmental, and fish health status conditions, but also to look for any adverse side effects, such as reduced growth or cosmetic problems.

To test for chronic mortality and vaccine potency, PHARMAQ challenges groups of vaccinated fish with live bacteria at timely intervals. This requires extensive wet lab facilities with many replicated tanks of fish.

Each lot of PHARMAQs licensed products are not only tested for sterility, safety, and efficacy at PHARMAQs laboratories, but are also sent to the USDNs regulatory facilities for duplicate testing.

PHARMAQ pioneered injectable vaccines for fish, and many millions of doses have proven them to be some of the most effective vaccines in the world. These vaccines offer long-term protection against up to five diseases from a single dose. However, because they are injected directly into the body cavity, injectable vaccines are more intensely tested for safety, not only to fish, but also to humans, who consume the fish. This is required by law for all injectable vaccines through the USDA Food Safety Inspection Services (FSIS).

Some pathogenic bacteria can produce toxins that are reactive to fish or crustaceans, which is one reason why even oral and immersion (dip) vaccines must be thoroughly safety tested.

Successful vaccination begins with product quality and ends with administration.

Through extensive experience, PHARMAQ has learned how extraneous variables can affect vaccine efficacy As the last step in our quality assurance program, we educate producers on how to maximize the value of vaccination and protect their businesses through attention to technique, hygiene, and the implementation of a comprehensive fish health program that uses vaccination as its cornerstone. PHARMAQ provides its customers with instructional materials, holds vaccination workshops and makes presentations at regional and international aquaculture meetings. We also work in concert with producers, extension agents and global academic and scientific communities to regularly provide the aquaculture industry with new and improved fish health technology.

At PHARMAQ, we take quality assurance very seriously. Our scientists continually research new aquatic animal health technology to address existing and emerging disease threats. However, we will not distribute a vaccine until we are absolutely certain that the product is safe, sterile and efficacious. We experiment in the lab, not on your farm. So, you can rest assured that when you use an PHARMAQ product, you're helping to protect and grow your investments.