FDA accepts Pfizer's meningococcal vaccine license application
The FDA also granted the bivalent recombinant vaccine, which is intended for people ages 10-25, a Priority Review designation.
"Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease," Emilio Emini, the senior vice president of vaccine research and development at Pfizer, said. "Both the acceptance of Pfizer's Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents."
The investigational vaccine is composed of two recombinant LP2086 antigens. Pfizer is currently conducting a global clinical development program for bivalent rLP2086 evaluating more than 20,000 participants, approximately 14,000 of which will receive the investigational vaccine.
The vaccine targets meningococcal disease caused by Neisseria meningitides serogroup B. Approximately 500,000 cases of meningococcal disease occur each year worldwide due to Neisseria meningitides.
Despite the availability of antibiotic treatment for the disease, there is currently no approved vaccine for meningococcal disease in the U.S.