The FDA’s Vaccines and Related Biological Products Advisory Committee voted 14 to 1 that the immunogenicity data on the vaccine, marketed as Prevnar 13 by Wyeth Pharmaceuticals Inc., supported its effectiveness in preventing pneumococcal disease caused by the serotypes contained in the vaccine in people aged 50 and older. The panel also voted 14 to 1 that the available data supported its safety in this older age group, with the panel’s consumer representative casting the no vote on both questions.
Prevnar 13 is under FDA review as an accelerated approval, which applies to products that "provide meaningful clinical benefit" over existing treatments for serious and life-threatening illnesses, which in the case of this vaccine is the protection of adults and the elderly from nonbacteremic pneumococcal pneumonia and protection from invasive pneumococcal disease, according to the FDA. A product can be approved under the accelerated approval regulation based on studies using surrogate effectiveness end points, if a follow-up clinical study confirming the benefits is conducted. If that study is negative, the FDA can withdraw approval.
The proposed adult indication for Prevnar 13 is for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the Streptococcus pneumoniae serotypes contained in the vaccine, in adults aged 50 years and older. Prevnar 13 was recently approved for this indication in 29 countries in Europe and 8 other countries.
The vaccine was approved in 2010 for preventing invasive disease caused by the S. pneumoniae serotypes in the vaccine in children aged 6 weeks through 5 years; it is also approved for preventing otitis media caused by seven serotypes.
The FDA usually approves products that win support from its advisory panels, and is due to make a final decision in January.
The agency is considering the vaccine under its accelerated approval process, meaning the FDA believes the medicine represents an unmet medical need.
The vaccine is designed to fight 13 forms of a bacterium called streptococcus pneumoniae, or pneumococcus.
Pneumonia caused by the pneumococcal organism is one of the biggest causes of death in older people and its incidence begins to increase after age 50.
The Prevnar vaccine is currently only approved for children, but Pfizer has said an expanded population of adults could generate more than $1.5 billion in annual sales for what is already among the world's biggest selling vaccines.
The Prevnar franchise -- known as Prevenar in Europe and other countries -- generated about $3.7 billion in global sales last year.
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