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Pfizer Receives European Approval To Expand Use Of Prevenar 13* To Adults Aged 18 To 49 Years For The Prevention Of Invasive Pneumococcal Disease

Prevenar 13, or Prevnar 13 as it is called in the United States, Canada and Taiwan, was first introduced for use in infants and young children in December 2009 in the EU. It is now approved in more than 120 countries worldwide for use in infants and young children, and in more than 80 countries for use in adults 50 years of age and older.

Pneumococcal Disease (PD)

Pneumococcal Disease is a group of illnesses caused by the bacterium S. pneumoniae, also known as pneumococcus. 3 It can affect people of all ages, although older adults, young children and individuals with certain chronic medical conditions are at heightened risk. 4,5 PD is associated with significant morbidity and mortality. 4,5 Invasive manifestations of the disease include bacteremia (bacteria in the blood) and meningitis (infection of the tissues surrounding the brain and spinal cord). 3,6

Indication for Prevenar 13 in Europe

Prevenar 13 is approved in the EU for the prevention of invasive disease, pneumonia and acute otitis media caused by S. pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in children and adolescents aged 6 weeks to 17 years. 1 It is also approved in the EU for the prevention of invasive disease caused by 13 S. pneumoniae serotypes (single dose) in adults 18 years of age and older. For the full prescribing information for Prevenar 13 in the EU, please see the Summary of Product Characteristics.

Indication for Prevnar 13 in the United States

  • Prevnar 13 is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 S. pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F) 7
  • Based upon immune responses to the vaccine, Prevnar 13 is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains 7
  • Prevnar 13 is not 100% effective and will only help protect against the 13 strains included in the vaccine 7
  • Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known 7

Important Safety Information

  • Prevnar 13 should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13 or any diphtheria toxoid–containing vaccine
  • Children and adults with weakened immune systems (e.g., HIV infection, leukemia) may have a reduced immune response
  • A temporary pause of breathing following vaccination has been observed in some infants born prematurely
  • The most commonly reported serious adverse events in infants and toddlers were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In children 6 weeks through 17 years, the most common side effects were tenderness, redness, or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever. Most commonly reported side effects in children 5 years through 17 years also included hives
  • In adults, immune responses to Prevnar 13 were reduced when given with injected seasonal flu vaccine
  • In adults, the common side effects were pain, redness, or swelling at the injection site, limitation of arm movement, fatigue, headache, muscle pain, joint pain, decreased appetite, chills, or rash
  • Ask your health care provider about the risks and benefits of Prevnar 13. Only a health care provider can decide if Prevnar 13 is right for you or your child

For the full prescribing information for Prevnar 13, please click here http://www.pfizer.com/products/#prevnar13.

Pfizer Inc: Working together for a healthier world™

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care 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 one of the world's premier innovative biopharmaceutical companies, we 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, please visit us at www.pfizer.com.

*Trademark. Prevnar 13™ is the trade name in the United States, Canada, and Taiwan.

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