New meningitis vaccine given approval by European Medicines Agency.
23 February 2012
MRF welcomes the news that a new meningitis vaccine – Nimenrix® has been given positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP).
The EMA recommends that Nimenrix® (MenACWY-TT) be licensed for individuals aged 12 months and above against meningococcal disease caused by serogroups A, C, W -135 and Y.
The positive opinion is one of the final steps before regulatory approval. As part of its assessment the EMA reviewed immunogenicity and safety data from more than 8000 patients aged 1 year and above. The clinical program included 17 clinical studies conducted in 17 countries worldwide. This new vaccine was submitted for approval by GlaxoSmithKline Biologicals.
Responding to this news Christopher Head, MRF’s Chief Executive, said: “We are delighted to see another meningitis vaccine recommended for licensure in Europe. This news marks another significant step in the fight against meningitis. This vaccine presents a renewed opportunity for broader protection against these deadly infections than is currently provided within the routine immunisation programme, and MRF urges government to consider its use.”
The vaccine offers protection against four major types of meningococcal disease, A, C, W and Y. Whilst this is promising news, it is important to remember that not all forms of meningitis and septicaemia are vaccine-preventable. For this reason, vaccine research must continue, and MRF is currently funding 19 research projects, many of which are focused on vaccine development.
It also remains crucial to be aware of the symptoms of meningitis and septicaemia.
Meningitis and septicaemia can be hard to recognise at first. Symptoms can appear in any order, and can include fever, vomiting, headache and feeling unwell, just like in many mild illnesses. Symptoms, such as cold hands and feet, pale or mottled skin, and limb, joint or muscle pain, often appear earlier than these symptoms so people need to be vigilant.
For information on the signs and symptoms of meningitis and septicaemia, you can call the Freefone helpline on 080 8800 3344 or download the free app from I-tunes: ‘Meningitis – Know the Symptoms’.