FDA approves Pfizer's Prevnar 13 for adults over 50

Pfizer ($PFE) has won a much-anticipated FDA approval for Prevnar 13 for older adults to prevent pneumonia and other diseases caused by 13 Streptococcus pneumoniae serotypes contained in the vaccine. The vaccine is already approved for children between the ages of 6 weeks and 5 years.

S. pneumoniae is responsible for 440,000 cases of pneumonia in older adults each year, and results in 200,000 ER visits and 300,000 hospitalizations annually, Pfizer explained in a statement. Vaccine chief Emilio Emini noted his company was granted accelerated approval for Prevnar 13 because of its potential to "address this significant disease burden."

An 85,000-person trial of Prevnar 13 is ongoing in the Netherlands, and investigators hope to determine whether the vaccine can prevent the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine. Pfizer will conduct a post-marketing study evaluating the use of Prevnar 13 and the annual flu vaccine in adults over 50.

"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the United States," said Pfizer CEO Ian Read (photo) 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."

The next stop for Pfizer is the CDC; insurance coverage of the shot will depend largely on whether the public health agency recommends the vaccine for older adults. Prevnar 13 raked in $2.82 billion in sales in the first 9 months of 2011, and expanded access to the vaccine promises to add significantly to Pfizer's bottom line.

- here's the FDA release on the approval
- check out Pfizer's release for more
- read the BusinessWeek article for more