In a 14-1 vote, a panel of FDA experts say Pfizer's ($PFE) Prevnar 13 protected adults over 50 from pneumococcal infections, paving the way for a likely approval in January. Earlier this week agency staffers said that the vaccine was more effective than Merck's ($MRK) vaccine Pneumovax at preventing the common infection pneumococcal pneumonia in adults. Additionally, staffers said no additional safety risks were identified from Pfizer's vaccine.
Prevnar 13 is currently approved for children 6 weeks to 5 years old, notes Reuters. Merck's Pneumovax is currently the only approved vaccine to prevent pneumococcal infections in adults, but Pfizer sees a lot of promise for Prevnar 13 in adult populations. Earlier this year, Pfizer vaccines chief Emilio Emini told FierceVaccines that adult vaccines would be a major target for the company, which inherited its vaccines division from Wyeth in 2009.
"For years the focus of vaccines has been in pediatrics, then adolescence," Emini said at the time. "Now we can also envision another group of vaccines for adults--such as the herpes zoster vaccine for shingles, the pneumococcal vaccine, a whole series of vaccines for the prevention of infection in older adults." The world's largest drugmaker is counting on an expanded approval of the vaccine to add $1.5 billion to Prevnar 13's $3.7 billion in annual sales.
The FDA will require ongoing studies of the vaccine to confirm that it sufficiently protects adults from pneumococcal infections. To that end, Pfizer is conducting an 85,000-person trial in the Netherlands, with results expected in 2013. Prevnar 13 is already approved in adult populations in the EU and 6 other countries.