19 March 2018
The primary objectives in both trials were met successfully and next steps towards documentation, approvals and production can commence to satisfy the global demand for sufficient and affordable IPV vaccine.
AJ Vaccines today announced the positive phase III results for its low-dose adjuvanted IPV vaccine. In two separate observer-blind, randomized and controlled clinical Phase III trials all primary objectives were met when comparing this new adjuvanted IPV vaccine to licensed IPV. The project can now enter its last phases. The product approval process, including WHO pre-qualification, will be initiated in 2018 with expected approval and initial sales in 2019.
The development project, funded by the Bill & Melinda Gates Foundation, was initiated in 2013 to develop a low-dose affordable IPV vaccine. The vaccine uses a formulation technology that allows for a smaller dose of active substances compared to a currently approved IPV vaccine. This will significantly decrease production cost, making it more affordable to use in the Global Eradication Campaign.
AJ Vaccines has worked in close cooperation with Statens Serum Institut to reach the pivotal phase III milestone and the global demand for affordable IPV vaccines is huge.
“At AJ Vaccines we are proud of having achieved today’s major milestone in the development of the vaccine. With the essential funding and support from Bill & Melinda Gates Foundation and through excellent cooperation with Statens Serum Institut we have reached this breakthrough making it realistic that before the end of 2019 we can offer affordable IPV vaccine to help reduce the gap between demand and supply for this essential vaccine and thus contribute to the global eradication of polio,” said Klaus Hermansen, CEO of AJ Vaccines.
AJ Vaccines plans to ramp up production to deliver polio vaccine to UNICEF and other pooled procurement programs and for delivery directly to the commercial market.
“We look forward to take our new IPV vaccine through the last phase and to the thousands of people who need affordable and efficient polio immunization globally. We have only come this far because of great partnerships, dedicated and skilled employees and our new ownership, making it possible to secure the necessary investments to finalize and deliver on a project of this scale,” said Klaus Hermansen.