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EMA Accepts Pfizer's MAA For 20-valent Pneumococcal Conjugate Vaccine Candidate For Adults

Pfizer Inc. (PFE) said the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in adults 18 years of age and older.

"The epidemiology of pneumococcal serotypes causing disease has been changing due to the success of pneumococcal conjugate vaccines targeting pediatric and adult populations. In many countries across Europe and around the world, more than half of all cases of invasive pneumococcal disease in older adults are due to the 20 serotypes covered in 20vPnC, including seven serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F) that are not included in any currently licensed pneumococcal conjugate vaccine," said Kathrin U. Jansen, Senior Vice President and Head of Vaccine Research and Development, at Pfizer.

The FDA has accepted for priority review the biologics license application of 20vPnC in adults 18 years of age and older, with a decision expected in June 2021.

In June 2020 Pfizer had announced the initiation of two Phase III trials for 20vPnC evaluating the safety and efficacy of the investigational vaccine in infants.

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