FDA Approves Pneumococcal Disease Vaccine for Older Adults

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At the end of December, the U.S. Food and Drug Administration (FDA) approved the vaccine Prevnar 13 for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium Streptococcus pneumoniae (S. pneumoniae). The drug is manufactured by the Wyeth Pharmaceuticals division of Pfizer Inc.

Pneumococcal pneumonia is caused when the S. pneumoniae bacterium infects the lungs, and is the most common disease caused by this bacterium in adults. When the bacterium invades parts of the body that are normally free from germs, such as the blood or spinal fluid, it is considered an invasive disease.

Among adults age 50 and older, there are an estimated 440,000 cases of pneumococcal pneumonia, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalizations. The Centers for Disease Control and Prevention reports that death occurs in 14 percent of hospitalized adults with invasive disease.

FDA approved the new use for Prevnar 13 under the agency’s accelerated approval procedure, which grants earlier approval of treatments for serious and life-threatening illnesses. The pathway allows for the demonstration of effectiveness of a vaccine using an immune marker that is reasonably likely to predict clinical benefit.

In clinical studies in the U.S. and Europe, people 50 and older received either Prevnar 13 or Pneumovax 23, a pneumococcal vaccine already for use in this age group. The studies showed that for the 12 common serotypes or sub-species of the bacteria, Prevnar 13 induced antibody levels that were either comparable to or higher than the levels induced by Pneumovax 23.

Under the accelerated approval, FDA is requiring an additional phase 4 clinical trial to document the efficacy of Prevnar 13. The trial involves more than 84,000 subjects to evaluate if Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.

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