What Can Happen If My Child is Not Vaccinated?

Infection with pneumococcal bacteria can cause serious illness and death. Before the introduction of Prevnar^®, invasive pneumococcal disease (IPD) caused about 200 deaths each year among children under
5 years old and approximately:

• More than 700 cases of meningitis
• 13,000 blood infections

Pneumococcal bacteria infection can also cause other health problems in children, including:

• Deafness
• Brain damage

REMEMBER: Even children who have been vaccinated with all 4 doses of Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) might not be protected against the strains of pneumococcal bacteria most commonly seen today.

What can I do to help protect my child against IPD? Vaccination is one way you can help protect against IPD. Prevnar^® was the vaccine developed to help protect infants and young children against IPD. It was made to protect against the 7 strains of pneumococcal bacteria that were most common before it was introduced. At that time, IPD caused thousands of serious infections and hundreds of deaths in young children. But since Prevnar^®, there are a lot fewer cases. In fact, in 2005, 77% fewer children under 5 got sick from IPD compared to 1998-1999.

However, other strains of pneumococcal bacteria not covered by Prevnar^® continue to make young children sick. That's why the introduction of Prevnar 13^® is important. Prevnar 13^® helps protect against 6 more strains of pneumococcal bacteria, including strains that are seen more today.

Learn more: The Importance of an Additional Dose of Prevnar 13^®

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^® 

INDICATION FOR PREVNAR^®

Prevnar^® is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of S. pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12 to 15 months of age.

Prevnar^® is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

As with any vaccine, Prevnar^® may not protect all individuals receiving the vaccine from serious invasive disease caused by S. pneumoniae. This vaccine should not be used for treatment of active infection.

IMPORTANT SAFETY INFORMATION FOR PREVNAR^®

In clinical studies, the most frequently reported adverse events included injection site reactions, fever (≥38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar^®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar^® does not protect 100% of children vaccinated. Immunization with Prevnar^® does not substitute for routine diphtheria immunization.

Please see Prescribing Information for PREVNAR^®