The FDA has approved a vaccine for adults 50 years and older to help prevent pneumonia. The vaccine Prevnar 13 will protect against 13 strains of bacterium called Streptococcus pneumoniae, or pneumococcus which causes meningitis, pneumonia and ear infections. Pneumonia is the biggest cause of death in older people. The FDA reported around 300,000 adults 50 or older are hospitalized every year for pneumococcal pneumonia.
Director of FDA’s Center for Biologics Evaluation and Research Dr. Karen Midthun said, “Pneumococcal disease is a substantial cause of illness and death. Approval provides an additional vaccine for preventing pneumococcal pneumonia and invasive disease in this age group.”
Pfizer’s chairman and chief executive, Ian Read said in a statement, “The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans.”
Currently the only vaccine for pneumococcal bacteria approved in the United States for adults 50 years of age or older is Merck & Co‘s Pneumovax. The only problem is, Merck (NYSE:MRK) is known as a free polysaccharide vaccine which means it’s only effective against invasive pneumonia and not effective on the more common, pneumococcal pneumonia. The new pneumonia vaccine by Pfizer, Prevnar 13 is a conjugate which means it contains a pneumococcal bacteria bound to a protein to help the body’s immune system recognize the bacteria and will have a longer lasting immune response time.
Prevnar 13 vaccine will help protect the pneumonia from invading into the lungs or other parts of the body like the blood system and spinal fluid, when the pneumococcus bacteria is present. According to figures from the Centers for Disease Control and Prevention 5,000 adults die from pneumonia every year.
Pfizer (NYSE:PFE) said the vaccine is already approved in European Union, Australia, Bolivia, Colombia, Ecuador, Thailand, and the Philippines. Known as Prevenar in Europe, it has had around $3.7 billion in sales this last year.
Prevnar 13 still needs to go through a confirmatory trial and is expected to be complete in 2013. Right now, more than 80,000 people are enrolled in the clinical trials in the Netherlands to help find out if the pneumonia vaccine will prevent pneumococcal pneumonia in adults and not just cause the body to produce antibodies.