Pfizer Inc announced that the US Food and Drug Administration (FDA) has granted approval of the company's pneumococcal conjugate vaccine Prevenar 13 (Pneumococcal 13-valent Conjugate Vaccine) as a single dose for use in adults. Prevenar 13 is indicated for adults 50 years of age and older for active immunisation for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.
"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the United States. The FDA approval of Prevenar 13 for these adults offers the potential to contribute to the health of millions of aging Americans," said Ian Read, chairman and chief executive officer, Pfizer Inc "This approval is representative of Pfizer's dedication to discovering and bringing to market life-changing medicines and vaccines."
Pneumococcal disease (PD) is a leading public health issue in adults 50 years of age and older, a population rapidly increasing in the United States. In this population, there are estimated to be hundreds of thousands of S. pneumoniae infections per year, including more than 440,000 cases of pneumococcal pneumonia, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalisations.
Pfizer's application to the US FDA was based on safety and immunogenicity studies involving approximately 6,000 adults 50 years of age and older. In these Phase 3 trials, vaccination with Prevenar 13 was shown to induce a functional antibody response to the 13 serotypes contained in the vaccine in adults 50 years of age and older, including individuals previously vaccinated with the conventional pneumococcal polysaccharide vaccine (PPSV) and those naïve to pneumococcal vaccines.
"As adults grow older they become more susceptible to infectious diseases, such as pneumococcal pneumonia, due to their aging immune systems," said Thomas M. File, Jr., M.D., M.S., president-elect, National Foundation for Infectious Diseases. "As a conjugate vaccine, Prevenar 13 offers an important new option for adults 50 years and older to include as part of their preventive strategy for healthy aging."
In addition to the United States, Pfizer has been granted approval for use of Prevenar 13 for various indications in adults 50 years of age and older in the European Union, Australia, Mexico and more than 10 other countries. Prevenar 13 was first approved by the US FDA in February 2010 for the prevention of invasive pneumococcal disease in infants and young children from 6 weeks through 5 years of age.-PR