The new adjuvanted polio vaccine has been approved by the Danish Medicines Agency, and the WHO prequalification is expected by the end of 2019, enabling initial delivery of up to 100 million doses globally via UN agencies in 2020-2024
COPENHAGEN, Denmark, June 28, 2019 /PRNewswire/ -- FOR MEDICAL AND TRADE MEDIA ONLY
AJ Vaccines today announced that its adjuvanted IPV vaccine has gained marketing approval in Denmark by the Danish Medicines Agency. The approval process was initiated in 2018 following positive results from clinical trials involving almost 3,000 infants. The Danish marketing approval paves the way for WHO prequalification with a view to enable AJ Vaccines to deliver doses to UN agencies such as UNICEF and PAHO early next year.
The marketing approval of the adjuvanted Inactivated Polio Vaccine (IPV) is a major milestone in the ongoing efforts made under the Global Polio Eradication Initiative established in 1988. The approved vaccine provides active immunization against poliomyelitis by primary vaccination in infants from the age of 6 weeks and for revaccination of infants, children, adolescents and adults. The vaccine is based on a proprietary formulation technology that allows a lower dose of active substances, it is a well-tolerated and non-inferior alternative to currently approved IPV vaccines.
"The approval of our new adjuvanted polio vaccine underlines the world-class innovation and development capabilities of AJ Vaccines. We are proud that our dedicated employees have deployed their combined skills to develop a groundbreaking vaccine, which has the potential to contribute greatly to the eradication of polio and reach millions of infants in need of affordable and effective immunization globally," said Jesper Helmuth Larsen, CEO of AJ Vaccines.
The marketing approval in Denmark and expected WHO prequalification, combined with the recent investment in a state of the art WHO GAPIII compliant polio vaccine manufacturing facility, form a strong foundation for establishing AJ Vaccines as a major contender in the global market for IPV vaccines during the global eradication endgame and for routing immunizations after the eradication.
"We expect the development and approval of the new vaccine will have a positive impact on the lives of millions of people, while simultaneously constituting a significant business potential and growth opportunity for AJ Vaccines. We aim to launch the product globally in early 2020 through partnerships with UNICEF and other pooled procurement programs as well as directly to the private market," said Jesper Helmuth Larsen.
The polio vaccine development project was initiated in 2013 in cooperation with and financial support from the Bill & Melinda Gates Foundation.
About AJ Vaccines
AJ Vaccines produces and sells vaccines from the company's production site in central Copenhagen which is proud to have been manufacturing vaccines since 1902. AJ Vaccines produces vaccines against Diphtheria, Whooping Cough, Tetanus, Tuberculosis, Polio and immunotherapy product for treatment of bladder cancer. The company has some 730 employees and expects to expand its skilled workforce in order to fulfill the ambitious growth plans.
See more at: http://www.ajvaccines.com/
SOURCE AJ Vaccines