Blockbuster prevnar pfizer inc in the vaccine ...

United States says Prevnar pneumonia vaccine for adults

(Reuters) - U.S. health regulators approved the expansion blockbuster vaccine Prevnar Pfizer Inc for use in adults 50 years and older to fight pneumonia, meningitis and other diseases, the air 'associated with the pneumococcus bacteria. Prevenar 13 is designed to deal with 13 forms of the bacterium Streptococcus pneumoniae, or pneumococcus. Pneumonia caused by pneumococcal organism is one of the leading causes of death in the elderly and its incidence begins to increase after 50 years. The vaccine, approved for children in the United States is already one of the biggest brands Pfizer and expanded populations of adults can bring more than $ 1. 5 billion annual turnover. Food and Drug Administration says about 300,000 adults in the United States that the elderly are hospitalized every year because of pneumococcal pneumonia. "Pneumococcal disease is a major cause of illness and death," said Dr. Karen Midthun, director of the Center for Biologics FDA evaluation and research. "Today's approval provides additional vaccine to prevent pneumococcal pneumonia and invasive disease in this age group."

Vaccines company Pfizer was considered under fast-track approval of FDA, which means the agency believes that medicine is not satisfied with medical needs. In November, the vaccine has provided support for FDA advisers who found him safe and effective as Merck & Pneumovax Co, which is currently the only vaccine for pneumococcal bacteria, approved in U.S. for adults age 50 and older. FDA stated that the senior vaccine from Merck, known as free polysaharydnoy vaccine was effective against invasive pneumonia, but it was shown that the effect of pneumococcal pneumonia, which often occurs in adults. Prevenar 13 belongs to a new purchase strattera generation of pneumococcal vaccines are known as conjugates that can cause more severe and more prolonged immune response. This vaccine can protect against pneumonia when the bacteria pneumococcus affects the lungs, as well as effective against the spread of bacteria to other parts of the body such as blood and spinal fluid. Side effects were similar Pneumovax Merck, including swelling at the injection site, fatigue, headache, muscle and joint pain. The vaccine is approved for adults age 50 and older in the European Union, Australia, Bolivia, Colombia, Ecuador, Thailand and the Philippines, Pfizer said. In total, Prevnar franchise - known as Prevenar in Europe and elsewhere - was about $ 3. 7000000000 in global sales last year. Under accelerated approval, Pfizer shall conduct a study to confirm that Prevnar 13 could actually prevent pneumococcal pneumonia in adults, not only cause the body to produce antibodies - which are usually used as a surrogate in clinical trials, FDA said. The results confirm the court, which trained more than 80,000 subjects in the Netherlands is expected in 2013. .