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FDA Approves New Vaccine Against Pneumonia
Last reviewed: 16.10.2021
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The FDA approved the Prevnar 13 pneumonia vaccine for use in people over 50 years of age. Prevnar 13 is a pneumococcal 13 valent conjugate vaccine that can prevent pneumonia and diseases caused by Streptococcus bacteria.
Karen Midtun, MD, director of the FDA Center for Biological Evaluation, said: "According to recent information, in the United States, about 300,000 adults aged 50 and older are annually hospitalized because of pneumococcal pneumonia."
Prevnar or Prevnar 13 is produced by Pfizer, while GlaxoSmithKline produces 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 diseases caused by 13 different serotypes of Streptococcus pneumonia bacteria and for preventing the inflammation of the middle ear caused by seven bacterial serotypes.
In later randomized multicenter studies in the United States and Europe, people aged 50 years and older received either Prevnar 13 or Pneumovax 23. Tests have shown that Prevnar 13 induces the production of protective antibodies at a level that is comparable to levels induced by Pneumovax 23 .
To confirm the safety of the product, the Prevnar 13 vaccine was tested by 6,000 people aged 50 years. The most frequent undesirable reactions were: pain, redness and swelling at the injection site, limiting movement of the hand, fatigue, headache, chills, decreased appetite, muscle pain and joint pain. Similar reactions were observed with Pneumovax 23.
Research data indicates that the product is relatively safe. In addition, studies are still in progress for 85,000 patients aged 65 years and older who have not previously received Pneumovax 23, in order to assess the clinical efficacy of Prevnar 13 in preventing pneumococcal pneumonia.
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