Pfizer's Trumenba is approved by the FDA to prevent serogroup B Meningococcal disease

WASHINGTON - Nov. 10, 2014 - PRLog -- The approval of Pfizer's Trumenba represents the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Trumenba had initially received accelerated approval from the FDA which is usually designated for therapies for serious or life-threatening diseases based on evidence of efficacy.

This approval stems from an immune response measured by serum bactericidal activity against four serogroup B strains demonstrative of dominant strains in the United States. Randomized studies were conducted in the United States and Europe in approximately 2, 800 adolescents and according to the results, 82 percent  who received three doses of Trumenba had antibodies in their blood compared with less than 1 percent before vaccination. Trumenba’s efficacy against other diverse strains has not been confirmed and Pfizer will continue with studies to assess effectiveness of the vaccine against different serogroup B strains.

“The approval of TRUMENBA is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer Inc. “Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the U.S. As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations.”

Meningococcal disease  is a life-threatening illness caused by the type of bacteria called Neisseria meningitidis, also known as meningococcus [muh-ning-goh-KOK-us]. The bacteria’s mode of transmission is usually through respiratory or throat secretions (e.g., by coughing, kissing, or sharing eating utensils). According to the Centers for Disease Control and Prevention, 160 cases of Meningococcal disease in 2012 were caused by serogroup B.

“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

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