Novartis said that its meningitis B vaccine, Bexsero, received the designation of a "breakthrough therapy" from the Food and Drug Administration (FDA). The Basel-based company plans to file for approval before June. The drug has already been used in the U.S. during the past few months at both Princeton University and the University of California, Santa Barbara, following meningitis B outbreaks on those campuses. Novartis provided roughly 30,000 doses of Bexsero to students and staff under the FDA’s Investigational New Drug designation, while the Centers for Disease Control and Prevention further recommended Bexsero to certain incoming freshman at Princeton.
"The recent outbreaks on US university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences," said Andrin Oswald, Division Head, Novartis Vaccines. "We will continue to work with the FDA to bring Bexsero to the US as soon as possible." Meningitis B is a rare yet aggressive disease that can kill or cause serious life-long disability within 24 hours of onset.
Bexsero has already been approved in Europe, Canada, and Australia to help protect against invasive meningococcal disease. In the UK, the Joint Committee on Vaccination and Immunisation recommended inclusion of Bexsero in the country's National Immunisation Programme for routine use in infants from 2 months of age. Bexsero marks Novartis’ fourth "breakthrough therapy" designation, which is intended to expedite the review process for new medicines that treat serious or life-threatening conditions. In the U.S., a licensed vaccine to protect against serogroup B remains an unmet public health need as currently available vaccines help prevent the other four most common serogroups that cause meningococcal disease (A, C, Y, and W).
The CDC explains that Bexsero will not give someone meningococcal disease, because it does not include any live bacteria. Common side effects include pain and tenderness in the arm (where the shot is given), swelling, and hardness of the skin. Other negative effects, which last a short amount of time, include nausea, feeling a little run down, and having a headache. With babies, parents may observe loss of appetite, sleepiness, unusual crying, diarrhea, vomiting, rash, fever, and irritability. Again, these effects generally last, at most, a couple of days.
Vaccination is considered the best defense against meningitis B because initial symptoms of the devastating disease are often unspecific and flu-like, making it difficult to diagnose. In fact, one in 10 people who become infected dying no matter what treatment they are given. Of those who do survive, one in five will suffer from life-long disabilities such as brain damage, hearing loss, or limb loss.