The US Food and Drug Administration (FDA) has approved the extended use of Pfizer’s pneumococcal conjugate vaccine- Prevnar 13 as a single-dose treatment for pneumonia in adults.
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The Prevnar 13 vaccine uses the company’s conjugate technology, which combines the pneumococcal polysaccharide sugar chains found on the surface of each bacterial serotype with a CRM197 carrier protein.
Pfizer said that the vaccine is indicated for active immunisation to prevent pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes in adults aged 50 and older.
The approval is based on Phase III safety and immunogenicity studies involving around 6,000 adults.
Pfizer chairman and CEO Ian Read said the FDA approval of Prevnar 13 for the adults provides the ability to contribute to the health of millions of aging Americans.
"This approval is representative of Pfizer’s dedication to discovering and bringing to market life-changing medicines and vaccines," Read added.
Pfizer Vaccine Research chief scientific officer Emilio Emini said Prevnar 13 was licensed under an accelerated approval pathway to help address pneumonia.
Currently, the company is performing a trial in adults to investigate whether Prevnar 13 is effective in preventing the first episode of community-acquired pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.
Pfizer has also agreed to conduct a study evaluating concomitant use of Prevnar 13 and annual trivalent inactivated influenza vaccine in adults aged 50 and older who have been previously immunized with pneumococcal polysaccharide vaccine.
Prevnar 13 has also been approved in the European Union, Australia, Mexico and a number of other countries.
Caption: Pfizer’s world headquarters.
