EU approval for meningitis vaccine
pharmafile | January 23, 2013 | News story | Sales and Marketing | Bexsero, CHMP, Novartis, meningitis
European regulators have approved Novartis’ Bexsero, making it the first broad coverage vaccine to target the leading cause of meningitis.
Bexsero (meningococcal group B vaccine) is aimed at preventing meningococcal serogroup B (MenB) infections in all age groups, and is designed to be used from two months.
Infants are at the highest risk for infection by MenB, which can lead to a sudden, aggressive illness capable of causing death within 48 hours and serious disability such as brain damage, limb loss or deafness in survivors.
Preventative vaccination programmes will certainly be one option considered by health authorities, and the manufacturer says it is working with governments to provide access to the new treatment ‘as soon as possible’.
“Our priority is to work with decision makers across Europe to ensure there is broad and timely access to vaccination,” said Andrin Oswald, division head, Novartis Vaccines and Diagnostics.
European Commission approval comes after the drug received a positive opinion from the CHMP in November.
Novartis says its tolerability and immunogenicity has been proved in Phase II/III trials involving almost 8,000 infants, children, adolescents and adults.
Meningitis UK Founder Steve Dayman welcomed the EC decision, saying Bexsero could ‘save thousands of lives’ and should be put into the immunisation schedule as soon as possible.
The approval is a feather in the cap for Novartis’ R&D operation: the vaccine was developed using so-called ‘reverse vaccinology’, decoding the genome sequence of MenB and selecting proteins most likely to be broadly-effective vaccine candidates.
Novartis now has, along with its existing jab Menveo, two brands which between them protect against all five main serogroups of meningococcal bacteria (A, B, C, W-135, Y) that cause the majority of meningitis cases worldwide.
Adam Hill
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