FDA Fast-Tracks Approval Of Serogroup B Meningitis Vaccine. USA Today (10/29, Szabo) reports that the FDA today “gave accelerated approval to a new meningitis vaccine,” called Trumenda, which “protects against type B” meningococcal bacteria. Previously, “vaccines targeted only four of the five major kinds of meningococcal bacteria – types A, C, Y and W.” Meningococcal bacteria are spread via “respiratory or throat secretions, such as through coughing, kissing or sharing drinks,” and can lead to the “sometimes life-threatening inflammation of the lining around the brain and spinal cord,” or “dangerous bloodstream infections.” According to CDC data, “There were 500 cases of meningococcal disease in the USA in 2012,” of which 160 were type B. Trumenda was developed by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. of Philadelphia. The Washington Post (10/29, Zauzmer) reports that meningitis outbreaks “sickened students at Princeton and at the University of California at Santa Barbara last year.” Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, “said that the 2013 outbreaks ‘underscored the urgent public health need’ for a vaccine for serogroup B meningcoccal disease” in the US. The affected schools “had to seek special permission to vaccinate their students” with a vaccine “that was not yet approved for use in the United States.” The CDC has not indicated “whether it would start recommending Trumenba for all adolescents or just for use in locations where a meningitis outbreak is occurring.” The New York Times (10/29, Thomas, Subscription Publication) adds that Trumenda’s approval “was based on results showing an immune response to four different strains of serogroup B,” which are the strains prevalent in the US. Pfizer has said the vaccine’s “effectiveness against other strains in the serogroup had not been confirmed and that the company was conducting additional studies.” The additional testing is a condition of approval. NBC News (10/30), the AP (10/30, Perrone), Reuters (10/29), HealthDay (10/30, Preidt), MedPage Today (10/30, Smith), and Medscape (10/30) also report on the story.
Posted on: Sun, 02 Nov 2014 20:39:40 +0000
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