30 October 2014 | News | By BioSpectrum Bureau
FDA grants approval for Pfizer's meningitis B vaccine
Globally around 20,000 to 80,000 people fall prey to meningitis every year (PC: consumerwarningnetwork.com)
Singapore: The US-based drug maker Pfizer scored high with the FDA winning approval for its novel meningitis B vaccine, Trumenba. Meningitis B is a potentially deadly bacterial disease that has recently caused many global outbreaks.
The vaccine is considered as one of the most important drugs in Pfizer's pipeline. Trumenba is approved for use in individuals under the age group of 10 to 25 years. The vaccine was granted accelerated approval recently, ahead of tests in 2,800 adolescents in the United States and Europe.
Trumenba showed promise in safety and efficacy tests, providing 82 percent protection against four different strains of meningtitis B that typically cause the disease. The most common side effects associated with the vaccine included inflammation at the site of the injection, headache and diarrhea.
According to Pfizer, globally around 20,000 to 80,000 people fall prey to Neisseria meningitidis. Though the disease can be treated with antibiotics, around 19 percent of survivors suffer permanent disabilities including brain damage and limb amputations.
Dr Emilio Emini, senior vice president, Vaccine Research and Development, Pfizer, said, "The approval of Trumenba is an important public health advance in protecting adolescents and young adults from invasive meningitis B. Pfizer is proud to have developed the first and only FDA-approved vaccine against the life-threatening and devastating disease."
Dr Emini further said that Pfizer was looking forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations. Trumenba is to be administered as a 3-dose series at an interval of 0, 2 and 6 months.