Has Pfizer Finally Hit Upon a New Blockbuster?
“Pneumococcal pneumonia is a significant cause of illness and death in adults around the world, and the potential to reduce the burden of this disease through direct vaccination of adults represents a meaningful public health benefit,” Pfizer’s (NYSE:PFE) senior vice president of Vaccine Research and Development, Dr. Emilio A. Emini, said in a Monday press release. That press release reported the results of the pharmaceutical company’s 85,000-patient study, which suggested that its Prevenar13 vaccine prevents community-acquired pneumonia, or pneumonia spread from normal social contact rather than a hospital, and invasive bacterial infection in adults aged 65 and older. According to Pfizer, that study was the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.
Both Prevenar — a vaccine currently used to prevent infection in infants and young children — and an older vaccine developed by Merck (NYSE:MRK) have been already approved by the U.S. Food and Drug administration in February 2010 to inoculate adults against the pneumococcus bacteria, which causes illness if allowed to enter the bloodstream or the lungs. However, so far, neither vaccine has been used with any regularity among adults because there exists no conclusive evidence as to how well the vaccine prevents people from contracting pneumococcal diseases. In fact, Pfizer’s Netherlands-based study marked the first time such a vaccine was ever used in that country, a fact that paved the way for the study to be completed there.
Prevenar was initially licensed by the FDA under an accelerated approval process to address the unmet medical need for a pneumonia vaccine for older adults, and this study was a requirement of the accelerated approval pathway.