Prevenar 13 is also approved for use in adults 50 years of age and older in more than 80 countries, and is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the older adult population.Prevenar 13 is marketed in the United States as Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]). In the United States, Prevnar 13 is not indicated for the prevention of pneumococcal pneumonia in the pediatric population. Pneumococcal Disease Pneumococcal Disease (PD) is a group of illnesses caused by the bacterium Streptococcus pneumoniae ( S. pneumoniae), also known as pneumococcus. While pneumococcus can infect people of all ages, infants, and young children and individuals with certain underlying chronic conditions, are at heightened risk. Certain underlying medical conditions, such as asthma and illnesses that impact a person’s immune system, can increase an individual’s risk of PD. PD is associated with significant morbidity and mortality. Indication for Prevenar 13 in Europe Prevenar 13 is approved in the EU for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type S. pneumoniae in infants and children from 6 weeks to 17 years of age and invasive pneumococcal disease in adults aged 50 years and older. Important Safety Information for Prevenar 13 The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas. In clinical studies, the most commonly reported adverse reactions were injection-site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Risks are associated with all vaccines, including Prevenar 13. Hypersensitivity to any component, including diphtheria toxoid, is a contraindication to its use. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Prevenar 13 does not provide 100 percent protection against vaccine serotypes or protect against non-vaccine serotypes.
Indications for Prevnar 13 in the United StatesIn the United States, Prevnar 13 is indicated for use in children six weeks through 5 years of age for the prevention of invasive disease (e.g., meningitis, bacteremia) caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The vaccine is also indicated in 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 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). Indication is based on immune responses. 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, 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 January 8, 2013. 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 potential indications for Prevnar 13/Prevenar 13 in age groups for which it has not received regulatory approval in various jurisdictions. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities in jurisdictions in which applications have been or may be filed for such potential indications regarding whether and when to approve such applications, as well as their decisions regarding labeling and other matters that could affect the availability and commercial potential of such indications; 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, 2011, and in its reports on Form 10-Q and Form 8-K. *Trademark