Novartis' Bexsero successfully protects vast majority of infants

A vaccine against meningococcal B disease, a devastating bacterial infection that is hard to diagnose and can kill in 24 hours, has come a step closer with infant Phase IIb data for Novartis' ($NVS) vaccine, Bexsero. The vaccine, also known as 4CMenB, could fill an unmet need--licensed vaccines are available to protect against meningococcal A, C, W-135 and Y disease, but there is no broadly effective vaccine available targeted against meningococcal B disease.

In the study, 1,800 infants were given three Bexsero shots during their first year, either at the same time as or separately from their routine shots. Almost all of the babies demonstrated the appropriate immune response to the vaccine. In addition, no major difference was observed when Bexsero was given alone or with other the routine vaccines.

"The development of a broadly protective vaccine against MenB disease has been a formidable challenge and, if successful, would represent an enormous step forward in the prevention of childhood meningitis," said Dr. Matthew Snape, consultant in vaccinology and general pediatrics, University of Oxford, U.K. "This study provides important data on how well infants' immune systems respond to this new MenB vaccine when given in a variety of schedules. This information is vital when considering how the vaccine could be incorporated into different immunization regimens around the world."

In a previous study, Bexsero protected nearly 100% of adolescents, and there have also been results showing the vaccine's effectiveness in protecting infants--it has been tested in Phase III trials in more than 8,000 infants, toddlers and adults. However, the significance of this particular study is the vaccine was well-tolerated and showed an effect when given with other routine vaccinations before the age of 1. This shows it can be used in the real world, as well as within the often strict environment of a clinical trial, and also can protect babies when they are most vulnerable to the disease. Bexsero is not currently available anywhere, but approval is pending in Europe and elsewhere, and the company hopes for a decision later this year.

- read the press release
- see the abstract of the paper in JAMA
- check out the abstract of an editorial in JAMA