Pfizer's (PFE) Bivalent rLP2086 treatment has received a breakthrough designation from the FDA for preventing Meningococcal B Disease in sufferers aged 10-25.
Pfizer is conducting Phase II and III trials for rLP2086 in studies that involve over 20,000 participants, of which 14,000 will receive the vaccine.
Meningococcal disease is caused by a bacterium called Neisseria meningitidis and can lead to meningitis and widespread blood infection (sepsis), as well as death or long-term disabilities such as brain damage and hearing loss.
Of the five main meningococcal serogroups, serogroup B is the only one for which there is no FDA approved broadly-protective vaccine. (PR)