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Pfizer Receives European Approval To Expand Use Of Prevenar 13 To Older Children And Adolescents Aged 6 To 17 Years For The Prevention Of Pneumococcal Disease

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.

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