FDA Approves New Vaccine Against Pneumonia
Last reviewed: 16.10.2021
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FDA approved the vaccine against pneumonia prevnar 13 for use in people over 50 years old. Prevnar 13 - pneumococcal 13-valent conjugated vaccine, which can prevent pneumonia and illness caused by Streptococcus bacteria.
Karen Midtun, Doctor of Medical Sciences, Director of the FDA Center for Biological Evaluation, said: "According to the latest information, about 300 thousand adults aged 50 years and older are hospitalized due to pneumococcal pneumonia in the United States."
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 to prevent invasive diseases caused by 13 different serotypes of Streptococcus pneumonia and for prevention inflammation of the middle ear caused by seven grades of bacteria.
In later randomized multicenter studies conducted in the United States and Europe, people at the age of 50 and older received either Prevnar 13 or Pneumovax 23. Testing showed that Prevnar 13 causes the production of protective antibodies at a level that are comparable to the levels induced by Pneumovax 23.
To confirm the safety of the product, the Prevnar 13 vaccine tested 6,000 people at the age of 50. The most common undesirable reactions turned out to be: pain, redness and swelling in the injection site, hand restriction, fatigue, headache, chills, appetite, muscle pain and joint pain. Similar reactions were observed with the use of Pneumovax 23.
Research data indicates that the product is relatively safe. In addition, studies of 85,000 patients aged 65 years and older who have not previously received Pneumovax 23 are still conducted in order to evaluate the clinical efficiency of Prevnar 13 in the prevention of pneumococcal pneumonia.
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