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FDA approves new pneumonia vaccine
Last reviewed: 01.07.2025
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The FDA has approved the pneumonia vaccine Prevnar 13 for use in people over age 50. Prevnar 13 is a pneumococcal 13-valent conjugate vaccine that can prevent pneumonia and illness caused by Streptococcus bacteria.
Karen Midthun, MD, director of the FDA's Center for Biologics Assessment, said: "The latest information suggests that in the United States, approximately 300,000 adults aged 50 and older are hospitalized each year due to pneumococcal pneumonia."
Prevnar or Prevnar 13 is manufactured by Pfizer, while GlaxoSmithKline makes a similar product called Synflorix. Synflorix was approved in February 2010 for use in children aged 6 weeks to 5 years for the prevention of invasive disease caused by 13 different serotypes of Streptococcus pneumoniae bacteria and for the prevention of otitis media caused by seven serotypes of the bacteria.
In more recent randomized, multicenter studies conducted in the United States and Europe, people aged 50 years and older received either Prevnar 13 or Pneumovax 23. The trials showed that Prevnar 13 induced protective antibody production at levels comparable to those induced by Pneumovax 23.
To confirm the safety of the product, the Prevnar 13 vaccine was tested in 6,000 people aged 50. The most common adverse reactions were: pain, redness and swelling at the injection site, limited arm movement, fatigue, headache, chills, decreased appetite, muscle pain and joint pain. Similar reactions were observed with Pneumovax 23.
The study data indicate that the product is relatively safe. In addition, studies are ongoing in 85,000 patients aged 65 years and older who have not previously received Pneumovax 23 to evaluate the clinical effectiveness of Prevnar 13 in preventing pneumococcal pneumonia.
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