Braasch Novel Vaccines Limit Need for Sub-Therapeutic Antibiotic Use
Boston, Massachusetts -- Based upon two recent events concerning antibiotic use in farm animals- a federal court decision and actions taken by the FDA, Braasch Biotech LLC is providing an update on the status of its Somatovac™ vaccines, developed as a novel alternative to the of sub-therapeutic use of antibiotics in animal feed.
On April 11, 2012, the U.S. Food and Drug Administration announced that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals. The FDA published the following “three steps” in the Federal Register:
1). A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
2). A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
3). A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.
Antimicrobial resistance occurs when bacteria or other microbes develop the ability to resist the effects of a drug. Once this occurs, a drug may no longer be as effective in treating various illnesses or bacterial infections. Because it is well established that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary.
The vaccines developed by Braasch Biotech are based upon issued and pending U.S. and International patents utilizing vaccination with innate immune responses to modulate growth parameters. Unlike drugs, the Braasch vaccines do not promote antibiotic resistance or increase in bacterial numbers in treated livestock. Explained Dr. Keith Haffer, President and Chief Scientific Officer, "Somatovac™ is a safe and timely alternative to the non-therapeutic use of antibiotics as its mode of action is initiated and sustained by the animal's own immune system.” Dr. Haffer further noted, “Although the technology has safely been utilized in thousands of farmed animals, we continue to scrutinize safety profiles and Mode of Action. In a recently completed grower pig study, we observed an increase in productivity, coinciding with maximal immune responses. Additionally, for the first time we studied the effects of vaccination at the molecular level in muscle tissue.” The vaccine technologies will not replace the use of antibiotics to treated bacterial infections, but do offer a solution which is beneficial to animals, farmers and consumers.
The Braasch technologies have already been recognized internationally for their inherent safety and efficacy by various producer organizations and veterinary vaccine manufacturers. Braasch is currently pursuing testing and registration in select international markets as well as the initiation of the registration processes with the FDA’s Centers for Veterinary Medicine (FDA-CVM).
The Somatovac™ technology utilizes vaccination against the naturally occurring, inhibitory hormone, Somatostatin. Immunization modulates levels of Somatostatin and allows the animal’s own endocrine system to adjust to higher productivity levels. The vaccine technologies are covered by various US and International patents and has applications in animal productivity, as well as in metabolic therapeutics.
About Braasch Biotech
Braasch Biotech LLC is a privately held biopharmaceutical company utilizing vaccination to influence the innate immune system and thus modulate metabolic processes. Braasch Biotech is headquartered in South Dakota with research, manufacturing and regulatory groups in the U.S. and internationally.
Jeralyn Kay Braasch, CEO & Chairman