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June 29, 2018

European approval for lower dose of GSk’s Meningitis vaccine

The European Medicines Agency (EMA) has approved GSK’s alternative 2+1 dosing schedule for its Bexsero vaccine to protect infants against invasive meningococcal disease (IMD) caused by serogroup B (Meningitis B).

The European Medicines Agency (EMA) has approved GSK’s alternative 2+1 dosing schedule for its Bexsero vaccine to protect infants against invasive meningococcal disease (IMD) caused by serogroup B (Meningitis B).

The new immunisation option involves two primary doses of Bexsero and one booster dose. It was observed that this reduced schedule stimulates an immune response similar to that of the existing 3+1 option.

Health care professionals and public health officials will now be able to continue the 3+1 schedule or start using the 2+1 Bexsero vaccinations at three months of age. The schedule requires a minimum interval of two months between the first and second dose.

GSK Vaccines senior vice-president and chief medical officer Thomas Breuer said: “Reducing the doses required to complete the course from four to three, with similar immune response, lowers costs and is easier on babies.

“Depending on local epidemiology or recommendations, the additional 2+1 schedule for Bexsero provides more options to complete a course of vaccination to help protect against Meningitis B infection.”

The authorisation for the 2+1 schedule comes after review of data from a previous study conducted to assess various Bexsero dosing schedules in healthy infants beginning from three months of age.

“Reducing the doses required to complete the course from four to three, with similar immune response, lowers costs and is easier on babies.”

Currently, Bexsero is licensed in more than 40 countries, including the EU, Argentina, Australia, Chile, Israel and Uruguay for individuals aged two months and above.

The Canadian indication is for 2-17 years of age, US approval covers people aged between ten and 25 years, and Brazil granted authorisation for two months to 50 years of age.

IMD is the leading cause of meningitis across the world. It develops rapidly and has flu-like symptoms making it hard to diagnose. Approximately one in ten who contract the disease die and 10% of those who survive may suffer a serious physical or neurological disability.

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