Pfizer seeds approval to expand Prevnar 13 ® use
Pfizer Inc (NYSE: PFE) today announced that it has submitted supplemental applications to both the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expand the use of Prevnar 13®* (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) to adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine.
The FDA is targeting a review cycle of 10 months from the application's submission date, resulting in an expected action date in October 2011, subject to the FDA's acceptance of the application. The EMA will follow the centralized procedure for review of Pfizer's application.
“We are pleased to be another step closer to potentially bringing Prevnar 13 to adults aged 50 and older,” says Emilio Emini, PhD, chief scientific officer, Vaccine Research, Pfizer. “These milestones are further examples of the company's commitment to help prevent pneumococcal disease through vaccination and to improve health and well-being at every stage of life.”
Prevnar 13, which is based on the scientific foundation of Prevnar®** (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), was approved for use in infants and young children in Europe in December 2009 and in the United States in February 2010. Like Prevnar, Prevnar 13 uses conjugate technology that has been shown to confer a high antibody response in infants and toddlers.
In the United States, Pfizer is seeking approval from the FDA to market Prevnar 13 for the active immunization of adults 50 years of age and older for the prevention of pneumococcal disease (including pneumonia and invasive disease) caused by the Streptococcus pneumoniae (S. pneumoniae) serotypes in the vaccine. In the European Union, the Company is seeking marketing authorization for active immunization for the prevention of disease caused by S. pneumoniae in adults aged 50 years and older. Pfizer plans regulatory submissions in additional countries in 2011.
Pfizer's applications to the FDA and EMA are based on six Phase III studies involving approximately 6,000 subjects. Data from the studies are expected to be shared in peer-reviewed forums beginning in 2011.
Pneumococcal Disease
Pneumococcal disease is a group of illnesses caused by the bacterium S. pneumoniae, also known as pneumococcus. It includes invasive infections such as bacteremia, sepsis, and meningitis, as well as non-invasive infections, such as pneumonia and otitis media. Pneumococcal disease is a major cause of illness and death in adults worldwide.
Indication for Prevnar 13 for Pediatric Use in the United States
In the United States, Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the sixth birthday). Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 serotypes of S. pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by seven serotypes of S. pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
Prevnar 13 is not indicated for the prevention of pneumonia in the United States.
Important Safety Information for Prevnar 13 for Pediatric Use in the United States
Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar, or any diphtheria toxoid–containing vaccine.
Prevnar 13 may not protect all individuals receiving the vaccine. Protection against ear infections is expected to be less than that for invasive disease.
Children with weakened immune systems may have a reduced immune response to Prevnar 13.
A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13 and Prevnar, respectively.
The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your child's health care provider.
Ask your child's health care provider about the risks and benefits of Prevnar 13. Only a health care provider can decide if Prevnar 13 is right for your child.
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