“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.
“We are pleased with the outcome of the [Community-Acquired Pneumonia Immunization Trial in Adults] study, which demonstrated that Prevenar 13 can prevent vaccine-type pneumococcal community-acquired pneumonia in adults,” Pfizer’s senior vice president for Vaccine Clinical Research, Dr. William Gruber, said in the press release. More specifically, the study found that Prevenar 13 prevented adults from community-acquired pneumonia caused by 13 strains of the s. pneumoniae bacteria, which was the study’s major goal. The study also meet Pfizer researchers’ secondary objectives: determining the efficacy of the vaccine against a so-called “first episode” of non-invasive, vaccine-type community-acquired pneumonia, where bacteria is not detected in the patient’s bloodstream, and efficacy against a first episode of vaccine-type invasive pneumococcal disease.
The full analysis of the study will be presented at a conference in India on March 12, but the fact that the study met its primary and secondary objectives is reason for analysts to be optimistic. Wall Street analysts will sift through the results of the trial as the data indicates Prevenar’s uses can be greatly extended, which could push sales to more than $5 billion, according to Reuters. Following the data release, investors — who bid shares up 16.91 percent in the past 12 months — pushed the stock up as much as 1.78 percent, to $32.02.
In a 2011 interview with Emini conducted by Forbes, titled “The Germ-Fighting Warrior Priming Pfizer’s Next Big Hit,” Matthew Harper quoted Vanderbilt University’s chair of preventive medicine, William Schaffner, as saying that if the trial shows Prevnar 13 can prevent pneumonia, “the interest of physicians and providers would shift very strongly toward that vaccine.” As Harper reported at the time, Pfizer believed the adult market for the vaccine could amount to $2 billion, while the size of the market was just $3.7 billion. That boost to Pfizer’s drug arsenal was much needed then, as it is now. Not only has the pharmaceutical company had an extremely poor track record for developing breakthrough and top-selling products, its legendary $11-billion-per-year drug Lipitor lost patent protection several years ago, making Prevenar a top seller.
Of course the problem is, as Emini told Harper, that, “Once you introduce a vaccine, if it’s a successful vaccine, within a very, very short period of time the disease that you are immunizing against goes away.”
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