Australian vaccine manufacturer has announced that its product Vaxsafe MS-H vaccine will achieve marketing approval for the EU 27 +2 countries in June, 2011. The registration process was undertaken and funded by Bioproperties directly, with local filing and technical assistance from its exclusive distributor, Pharmsure, based in the UK.
“Vaxsafe MS-H is a unique and highly effective live attenuated and temperature sensitive vaccine for the control of Mycoplasma synoviae (MS) related Chronic Respiratory Disease (CRD) in poultry,” said Dr Chris Morrow, Technical & Marketing Manager of Bioproperties.
Vaxsafe MS-H induces lifelong local (respiratory) and systemic immunity against MS from a single application. The economic benefits of using the vaccine and the reduction in the use of antibiotics to control MS are very substantial. It is available in 1000 dose vials: it is administered by eye drop to breeders and layer type birds and was first registered in Australia in 1995.
The vaccine has been registered in many key countries since its Australian debut and additional registrations in the next 2-3 years should see it registered in all key poultry producing countries by 2014. All product is supplied from Bioproperties’ Glenorie Vaccine Manufacturing Facility which has been certified to produce and export the vaccine for the most stringent GMP regulatory standards.
“MS-H vaccine is now recognised by leading global poultry entities as a key Australian developed poultry vaccine manufactured to the very stringent European standards in Australia.” Dr David Tinworth, Bioproperties Managing Director said.
“The current EU regulatory systems are so complex that few new poultry vaccines will eventually reach the market as huge costs are involved for what are often limited financial returns so a new product really needs to be very significant and differentiated to justify the costs of its registration.
“As a result of this fact much of the innovative R & D into poultry vaccines may end up not reaching the European market,” he predicted. “The focus in Europe has now moved to less effective ‘autogenous’ types of vaccines which do not have to be registered as a way to deal with specific disease issues,” he added.
“Development of this vital MS-Hvaccine was jointly funded by Bioproperties, the University of Melbourne and the RIRDC. It is not only a great achievement for our company but for Australian animal health research in general,” Dr Tinworth concluded.