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Double boost for VaxLiant vaccines with US approvals

By Joseph Harvey

On the same day it secured four US approvals for its vaccine adjuvants, US firm VaxLiant also saw its technology used in two new AgriLabs products.

The Lincoln, Nebraska-based firm received approval from the US Department of Agriculture (USDA) for four ready-to-use ENABL adjuvants that can be added to vaccines to help improve the resulting immune response in cattle and swine.

Two of the approved adjuvants are for use in cattle vaccines, while two are for use in swine vaccines.

The latest approval means VaxLiant has received USDA authorization for 10 adjuvants in the last year – six adjuvants were approved in July 2014.

The company said all of the adjuvants include a 21-day withdrawal period when ENABL is used in vaccines administered either subcutaneously or intramuscularly.

Steve Schram, one of VaxLiant's co-founders, explained: "A 21-day withdrawal period, which is the shortest allowed by the USDA for food-animal vaccines, is especially important when developing vaccines for practical use in cattle and pigs.

"Beyond that, having access to innovative adjuvants that already are approved for safety means manufacturers can reference existing withdrawal studies that meet stringent USDA standards. This can reduce the development time needed to bring new vaccines to market."

Tim Miller, also a VaxLiant co-founder, said: "Until recently, a key hurdle to using DNA, gene-vector and other next-generation technologies to develop vaccines has been access to adjuvants that are versatile enough to accommodate these unique platforms.

"Access to a variety of ENABL formulations has eliminated that hurdle by offering never-seen-before stability and strong immune response, while enabling new approaches for antigen recovery in product-release assays."

AgriLabs launches ENABLed vaccines

VaxLiant is a virtual company formed as a joint venture between biologics development firm Benchmark Biolabs and animal health products distributor AgriLabs.

St Joseph, Missouri-based AgriLabs has launched two new autogenous vaccines made with VaxLiant's ENABL adjuvant technology for beef and dairy cattle.

The vaccines, developed in partnership with Addison Biological Laboratory, are against Moraxella bovoculi and Streptococcus uberis mastitis.

Fayette, Missouri-based Addison Labs is the manufacturer of the licensed autogenous vaccines that contain ENABL, while AgriLabs is the exclusive distributor for these vaccines.

"This product expansion further strengthens a partnership with Addison Labs that has been a significant asset to the growth of I-Site XP, a broad protection vaccine against pinkeye," said Brian Reardon, business unit manager for AgriLabs.

"By extending this partnership with Addison Labs, we are ensuring producers have more access to herd-specific vaccines as herd conditions change."

M bovoculi – otherwise known as pinkeye and associated with Moraxella bovis – is an increasing problem amongst cattle.

“A single dose of the I-Site XP vaccine protects cattle against M bovis,” Mr Reardon added. “There is no commercial vaccine against M bovoculi. Having an M bovoculi autogenous vaccine constructed by Addison Labs, marketed by AgriLabs, is an excellent choice.”

S uberis is the most common Streptococcal species isolated from mastitis case submissions in the UK, New Zealand and the US. It is described by AgriLabs as being "the greatest nemesis to economical milk production to all herds worldwide".

The company said: "The vaccine production process for this organism is efficient and allows the use of autogenous vaccines as an effective tool in the battle against such a formidable and significant mastitis opponent as S uberis. All combination of Streptococcus can be included in the formulation as well as other causative autogenous bacteria. Bovine E coli and Clostridium autogenous are also available."

The adjuvants used in these two vaccines are part of the six-pronged USDA approval VaxLiant secured in July 2014.

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J Bruce Addison, president for Addison Labs, said: "Environmental conditions are constantly in flux giving rise to new diseases and organisms. When a farm encounters an organism that is unique or variant, veterinarians and producers are faced with a challenge of how to handle the situation. If a commercial vaccine is not available for the bacterium, an autogenous vaccine may be useful."

VaxLiant's versatile adjuvant technology aims to allow vaccine manufacturers to create products to treat specific disease outbreaks. The formulations used by VaxLiant are adaptable to various delivery methods, such as the transdermal, aerosol and oral routes.

After being established in 2013, VaxLiant has already recorded its first revenues.


Posted with permission of Animal Pharm, Informa Agra, Christchurch Court, 10-15 Newgate St., London, UK EC1A 7AZ,
+44 (0)20 7017 7500,

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