FDA to Review New Meningitis B Vaccine

Meningitis B is a serogroup of meningococcal bacteria and is the most common case of bacterial meningitis. Two drug manufacturers announced on Tuesday that they've submitted applications to the FDA for their meningitis B vaccines.

Novartis and Pfizer hope that the Food and Drug Administration swiftly review and approve their applications for the first-ever vaccines that could prevent meningitis B - a sometimes fatal strain of meningitis. The bacterial infection affects over 200 people each year in the U.S., killing 10% of those infected and leaving another 20% with lifelong side effects.

Bexsero, Novartis' vaccine, has already been approved in the European Union, Canada, and Australia, and over 30,000 doses were given to students and staff at Princeton University and UC Santa Barbara following meningitis B outbreaks last year. Their vaccine is aimed to treat adolescents and young people.

Pfizer's bivalent rLP2086 (along with Bexsero) was granted breakthrough therapy status by the FDA in recent months, which could expedite the approval process. Pfizer began conducting a global clinical development program for their drug in March, which included over 20,000 participants, 14,000 of whom received the vaccine.

Both companies hope to help treat those who are affected by the bacterial infection each year (estimated between 20,000 and 80,000). A considerable percentage of meningitis B sufferers either die or develop serious complications such as brain damage, hearing loss, or learning disabilities. Infants and young children are most susceptible and affected by Haemophilus influenza type b (meningitis B).

The Meningitis Research Foundation in the UK has praised Bexsero's effectiveness, revealing that its past trials were successful because the vaccine triggered a strong immune response in infants, toddlers, and adolescents. It is now available for free in the UK for people with medical conditions that increase their risk of meningitis B.

"It's clearly the vaccine that makes the most sense," said Dr. Andrin Oswald, head of Novartis' vaccine division, in this NBC News article. "For most parents, they want to protect their children and teenagers with one shot."

However, once approved, it could still take months before either vaccine is available to consumers in the United States.