Delay expected as meningitis vaccine gets EU approval

A lifesaving vaccine against the deadliest form of meningitis has been approved by EU scientists but it will take at least a year before it is available in Ireland, the country which has the highest rate of the disease in Europe.

The European Medicines Agency, which scientifically evaluates medicines developed for use in the EU, yesterday gave the green light to 4CMenB, a vaccine developed by Swiss drug manufacturer Novartis. It protects against the B strain of meningitis which claims the lives of around 17 Irish people every year, mostly young children.

Meningitis B is one of the most feared strains of the illness, as it can kill in less than 24 hours and leaves survivors with devastating disabilities.

It is caused by bacteria, leading to inflammation of the lining around the brain and spinal cord and infants are at the highest risk.

Testing of the new vaccine against meningococcal B meningitis and septicaemia (MenB) revealed that just two doses gave effective protection to young children, teenagers, and adults against roughly 80% of meningitis strains that are found in Europe.

Ireland’s leading meningitis charity, Meningitis Research Foundation, has welcomed the news that the potentially lifesaving vaccine is one step closer.

According to the foundation, the B strain is responsible for an average of 170 cases across Ireland each year, mostly in young children. Around one in 10 people affected will die, and a further one in 10 survivors will be left with serious after-effects, such as limb amputations, deafness, blindness, and brain damage.

The new vaccine will require a licence from the European Commission before governments can consider it for implementation.

In Ireland the Government takes vaccination advice from the National Immunisation Advisory Committee. If it agrees, the earliest it could be implemented in Ireland will be the end of 2013, says the Meningitis Research Foundation.

“The incidence of meningococcal serogroup B (MenB) disease in Ireland is the highest in Europe, killing more children under five years of age than any other infectious disease.” said the foundation’s manager, Diane McConnell.

“The lack of a vaccine has meant too many Irish parents are grieving for their children or left coping with serious life-long disabilities. It’s why we campaign so hard to raise awareness of the symptoms and fundraise for vital research. News that a MenB vaccine is finally on the horizon is more than welcome, and the next step is to get it on the routine immunisation schedule as a priority and start saving lives.”

There are five types of bacterial meningitis. While vaccines exist to protect against the other four, none has previously been licensed for type B meningitis. In Europe, type B is the most common, causing 3,000 to 5,000 cases every year.

Novartis said it was committed to making the vaccine — to be sold under the trade name Bexsero — available “as soon as possible.”

In a statement, Andrin Oswald of Novartis said he is “proud of the major advance” the company has made in developing its vaccine. It is aimed at children over two months of age, and Novartis is hoping countries will include it in routine vaccination against childhood diseases like measles.

* For more information on the disease, go to www.meningitis.org/MenB

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