FDA accepts for priority review Biologics License Application (BLA) for 15-valent pneumococcal conjugate vaccine (V114)

V114 is a 15-valent pneumococcal conjugate vaccine made up of pneumococcal polysaccharides from 15 serotypes, including 22F and 33F, which are linked to invasive pneumococcal disease in older adults globally and are not in pneumococcal conjugate vaccines currently on the market.

SPS commentary:

The BLA are built on data from phase II and III trials in healthy adults and ones at increased risk, such as HIV patients, people with chronic medical conditions, and people 65 years of age and older. The vaccine is also being reviewed by the European Medicines Agency,

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