Influenza vaccine
Regulatory affairs services provider ELC Group has signed up for the early-stage development of a novel vaccine targeting prevention of influenza, signalling the organisation's entry into the pharmaceutical development market.
The vaccine development will be overseen by a specialist R&D team at ELC Group, including regulatory vaccines experts who have worked on and regulated a number of key worldwide paediatric vaccines. The highly experienced team includes a number of current advisers to the World Health Organisation (WHO).
ELC Group is working with pre-clinical partners to carry out toxicity and immunogenicity testing, and is harnessing innovative new techniques to create the novel vaccine. ELC Group will also be responsible for setting up the regulatory pathway to ensure a smooth transition to market and approval from international regulators. The market value of the project assigned to ELC Group is an estimated €1m.
According to WHO 2014 figures, the global incidence rate of influenza is estimated at 5–10% in adults and 20–30% in children. Illnesses can result in hospitalisation and death mainly among high-risk groups (the very young, elderly or chronically ill). Worldwide, annual epidemics rates are currently estimated to result in about 3 to 5 million cases of severe illness and about 250, 000 to 500, 000 deaths globally.
Commenting on the vaccine development, ELC Group CEO Marco Rubinstein said: “We are very excited to be moving into the pharmaceutical development market with this key launch project, targeting an important therapeutic area. With the ability to take this product through our concept to commercialisation model by our unrivalled team of world-class team experts, we are confident of a successful project delivery.”