On Oct. 29, 2014, Pfizer announced the U.S. Food and Drug Administration (FDA) had granted accelerated approval of TRUMENBA^® (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed. As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains.

TRUMENBA was reviewed and approved under the FDA’s Breakthrough Therapy designation and Priority Review programs.

Meningococcal disease can be unpredictable and occur quickly and without warning in otherwise healthy individuals. Outbreaks and cases of meningococcal group B disease occurred in the U.S. in 2013 and 2014. The majority of invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis serogroups (A, B, C, W and Y). In 2012, approximately 40 percent of all meningococcal disease cases in the U.S. were caused by serogroup B. Meningococcal disease affects all age groups in the U.S., but incidence is highest among infants younger than one year, adolescents and young adults, and the elderly.

Meningococcal disease may result in life-altering, significant long-term and permanent medical disabilities. Despite the availability of antibiotic treatment, between 10 and 15 percent of patients with meningococcal disease die and 11 to 19 percent of those who survive are afflicted with long-term disabilities, such as brain damage, hearing loss, learning disabilities or limb amputations.

TRUMENBA (meningococcal group B vaccine) is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years of age. Approval of TRUMENBA is based on the demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.