NEW YORK CITY (dpa-AFX) - Pfizer Inc. (PFE) announced Friday that the U.S. Food and Drug Administration has granted approval of pneumococcal conjugate vaccine Prevnar 13, or Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein], as a single dose for use in adults.
Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine.
Pneumococcal disease is a leading public health issue in adults 50 years of age and older, a population rapidly increasing in the United States.
Pfizer said that it is currently conducting the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA) to fulfill requirements under the accelerated approval pathway.
In addition, Pfizer has agreed, as a post-marketing commitment in connection with the approval by the U.S. FDA, to conduct a study evaluating concomitant use of Prevnar 13 and TIV or annual trivalent inactivated influenza vaccine in adults 50 years of age and older who have been previously immunized with PPSV.
In addition to the United States, Pfizer has been granted approval for use of Prevnar 13 for various indications in adults 50 years of age and older in the European Union, Australia, Mexico and more than 10 other countries.
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