NEW YORK, Dec. 22, 2010 /PRNewswire/ -- 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.
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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.
For full product and prescribing information for Prevenar 13 in the European Union, please click here.
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
DISCLOSURE NOTICE: The information contained in this release is as of December 22, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding a potential indication for Prevnar 13 for use in adults in various markets, including the U.S. and the EU, and the potential benefits of Prevnar 13. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory applications will be submitted in various markets other than the U.S. and the EU for a potential indication for Prevnar 13 for use in adults; whether and when the FDA, the EMA and regulatory authorities in other jurisdictions will approve applications that have been or may be submitted for this potential indication and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.
* Prevnar 13 is referred to as Prevenar 13*** in most countries outside the United States.
**Prevnar is referred to as Prevenar*** in most countries outside the United States.
*** Trademarks.
SOURCE Pfizer Inc.