Prevnar 13: Pneumococcal 13-valent Conjugate Vaccine
   

*Compared to Prevnar®
About the Importance of an Additional Dose of Prevnar 13®
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What Diseases Can Pneumococcus Cause?

Pneumococcal disease (PD) includes some infections that may be familiar to you, such as meningitis (an infection of the covering of the brain and spinal cord), bacteremia (an infection in the blood), and otitis media* (an ear infection).

Bacterial Meningitis
Prior to the introduction of Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), pneumococcal bacterial strains were the most common cause of bacterial meningitis in the United States. Before the introduction of Prevnar®, there were more than 700 cases of pneumococcal meningitis annually in children under 5 years of age. And this can be a very serious infection: in one 1998 study, pneumococcal meningitis in childhood was associated with a 7.7% death rate. It can also lead to neurological problems (25%) and hearing loss (32%).

Bacteremia
Before the introduction of Prevnar®, there were an estimated 13,000 cases of pneumococcal bacteremia every year in children under the age of 5. Bacteremia often resolves on its own, but it can lead to serious infections such as sepsis (disease caused by the spread of bacteria in the bloodstream) and meningitis. Bacteremia occurs when bacteria continue to multiply in the blood and spread to other sites in the body.

Ear Infection
Some pneumococcal infections, such as an ear infection, are not invasive or life-threatening. Pneumococcal ear infections are an inflammation of the middle ear that can cause ear pain, irritability, loss of appetite and fever. It can be caused by a variety of viruses and bacteria in addition to pneumococcus. Pneumococcal bacterial strains were responsible for 20% to 40% of bacterial ear infections before the introduction of Prevnar®.

Complications of pneumococcal ear infections include fluid remaining in the ear (persistent effusion), which can lead to hearing loss and problems with language development. More than 60% of all children experience an episode of ear infection by the age of 1 year, and more than 90% have had an episode by the age of 5 years. Ear infections and other ear tube disorders resulted in nearly 25 million doctor visits in 1997.

Prevnar 13® protection against ear infections is expected to be less than that for invasive disease.

Prevnar 13® can only help provide protection against ear infections caused by the seven strains found in both Prevnar® and Prevnar 13®.

Learn more: Why Is There Still a Risk of IPD?

INDICATIONS FOR PREVNAR 13®

  • Prevnar 13® is a vaccine approved for use in children 6 weeks through 5 years for prevention of invasive disease (caused by the 13 strains of Streptococcus pneumoniae included in the vaccine) and ear infections (caused by 7 of the 13 strains)
  • Based upon immune responses to the vaccine, Prevnar 13® is also approved for adults 50 years and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains
  • Prevnar 13® is not 100% effective and will only help protect against the 13 strains included in the vaccine
  • Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known

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 (eg, 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 children were bronchiolitis (an infection of the lungs) (0.9%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%), and pneumonia (0.9%)
  • In infants and toddlers, the most common side effects were tenderness, redness or swelling at the injection site, irritability, decreased appetite, decreased or increased sleep, and fever
  • 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 your child

You are encouraged to report negative side effects of vaccines to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.

Please see Prescribing Information for Prevnar 13® Adobe Reader

*Compared to Prevnar®

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PREVNAR® and PREVNAR 13® are registered trademarks of Wyeth LLC.
Wyeth Manufactured by Wyeth Pharmaceuticals Inc.   Marketed by Pfizer Inc.
PSP445810-01   © 2012 Pfizer Inc.   All rights reserved.   March 2012
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