(RxWiki News) A European agency has taken a step toward approving a new meningitis vaccine. It will be the first vaccine for all age groups for a particularly deadly and common strain of meningitis.
"Follow established immunization schedules."
The Committee for Medicinal Products for Human Use (CMPH) within the European Medicines Agency (EMA) – a European version of the US Food and Drug Administration – has issued a "positive opinion" for the Bexsero meningitis B vaccine.
The next step will be for the EMA to approve the vaccine for use, which will be for individuals aged two months and older.
Meningitis B accounts for up to 90 percent of all the meningitis cases throughout Europe and up to 60 percent of all meningitis cases in the US. The disease is most common in children under one year old.
The disease is frequently misdiagnosed because its symptoms resemble those of many other conditions.
Meningitis B can also kill a person within 24 hours. About 10 percent of all patients who contract it die from the disease even if they are treated, and one in five of those who survive end up with serious disabilities, such as brain damage, deafness or losing limbs.
Typically, drugs recommended by the CMPH are approved for use by the European Commission within three months. This approval would apply to all countries in the European Union and the European Economic Area.
The studies showing the effectiveness and safety of the vaccine included trials with just under 8,000 babies, children, teenagers and adults.
Novartis is still having discussions with the US FDA regarding additional necessary trials on effectiveness of the vaccine before they can file for approval in the US.