The Food and Drug Administration (FDA) has given accelerated approval to Trumenba, the first vaccine licensed in the United States to prevent meningitis B in people 10 to 25 years old.
Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream and the lining that surrounds the brain and spinal cord. The bacterium N. meningitidis is a leading cause of bacterial meningitis.
The bacteria are passed from person to person through respiratory or throat secretions, which can be spread by coughing, kissing, or sharing eating utensils.
In 2012, about 500 cases of meningococcal disease were reported in the United States. Of those cases, 160 were caused by serogroup B, according to the Centers for Disease Control and Prevention (CDC). The B bacterial strain has also been responsible for six deaths of college students in the past couple of years.
Prior to the approval of Trumenba, meningococcal vaccines approved for use in the United States have only covered four of the five main serogroups of N. meningitidis: groups A, C, Y, and W.
“Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a press statement. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”
Key symptoms of meningitis include a fever, stiff neck, headache, nausea, and flu-like symptoms.
The safety of Trumenba was assessed in about 4,500 individuals who received the vaccine in studies conducted in the United States, Europe, and Australia.
Three randomized studies were also conducted in the United States and Europe in about 2,800 teens. Among study participants who received three doses of Trumenba, 82 percent had antibodies in their blood that killed four different N. meningitidis serogroup B strains, compared with less than 1 percent of participants before vaccination. These four strains are representative of strains that cause serogroup B meningococcal disease in the United States.
The most commonly reported side effects of Trumenba were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.
Trumenba is manufactured by Wyeth Pharmaceuticals, a subsidiary of Pfizer. Accelerated FDA approval, which is given to products that address life-threatening diseases, requires Wyeth to perform additional long-term safety tests on Trumenba.