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World Health Organization Grants Expansion To The Prequalification For Prevenar 13 To Include Adults 50 Years Of Age And Older

The First and Only Conjugate Vaccine

Prevnar 13/Prevenar 13 is the only pneumococcal conjugate vaccine approved for use in adults 50 years of age and older. The vaccine uses company-pioneered conjugate technology that links the pneumococcal antigens to a carrier protein CRM 197, which has more than 20 years of clinical and commercial use in vaccines.

About Pneumococcal Disease

Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae, also known as pneumococcus, which can infect people of all ages, although young children, older adults and individuals with certain chronic medical conditions are at heightened risk. Invasive pneumococcal disease occurs when bacteria invade parts of the body that are normally free from bacteria, such as blood or spinal fluid.

Pneumococcal disease is a leading global public health problem associated with high mortality and morbidity. It can be difficult to diagnose, as antibiotic-resistant strains can complicate treatment decisions, cause treatment failures, as well as increase the duration and cost of care.

Symptoms of pneumococcal disease vary depending on the particular type of clinical illness and its severity. For example, symptoms of pneumococcal pneumonia can include fever, shaking chills, cough and shortness of breath, while symptoms of pneumococcal meningitis can include fever, headache and neck stiffness.

Indications for Prevnar 13/Prevenar 13

In the United States, Prevnar 13 is 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). The vaccine is also 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).

In the European Union, Prevenar 13 is indicated for active immunisation for the prevention of invasive pneumococcal disease caused by Streptococcus pneumoniae in adults aged 50 years of age and older caused by 13 Streptococcus pneumoniae serotypes. The vaccine is also indicated for active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from six weeks to 5 years of age.

Important Safety Information for Prevnar 13

  • 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
  • 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
  • In adults, immune responses to Prevnar 13 were reduced when given with injected seasonal flu vaccine
  • 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

For the full prescribing information for Prevnar 13 in the U.S., 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 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.

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