The Importance of an Additional Dose

An effective way to help prevent invasive pneumococcal disease (IPD) is through vaccination.
Since 2000, a vaccine called Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) has been available to help protect young children against IPD. Prevnar^® offers protection against 7 strains of pneumococcal bacteria.

However, additional strains of pneumococcal bacteria that are not covered by Prevnar^® continue to cause serious disease in young children. Certain diseases, such as pneumococcal meningitis (an infection of the tissues surrounding the brain and spinal cord), can result in long-term disability or death. That's why it's important to ask your child's health care provider about Prevnar 13^®.

Prevnar 13^®, indicated for children 6 weeks through 5 years of age, offers broader coverage than Prevnar^® because it helps protect against 6 additional strains of pneumococcal bacteria. If your child is 15 months to 5 years of age and has received a full 4-dose series of Prevnar^®, you and your child's doctor can provide coverage against 6 more strains of pneumococcal bacteria with an additional dose of Prevnar 13^®.

The immune responses provided by this dose of Prevnar 13^® might not increase the number of antibodies ("infection-fighting cells") for the 6 additional strains (types 1, 3, 5, 6A, 7F, and 19A), as much as if your child had received the full 4 doses of Prevnar 13^® (routinely given at 2, 4, 6, and 12 to 15 months). It's not known how medically important this difference is.

Ask your child's health care provider about the risks, benefits, and if
Prevnar 13^® is right for your child.

INDICATION FOR PREVNAR 13^®

• Prevnar 13^® is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday).
• Prevnar 13^® is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
• Prevnar 13^® is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13^®

• Prevnar 13^® should not be given to anyone with a severe allergic reaction to any component of Prevnar 13^®, Prevnar^® or any diphtheria toxoid–containing vaccine.
• Prevnar 13^® may not protect all individuals receiving the vaccine.
• Protection against ear infections is expected to be less than that for invasive disease.
• Children with weakened immune systems may have a reduced immune response to Prevnar 13^®.
• A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
• The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs) (0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine) (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13^® and Prevnar^®, respectively.
• The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Any side effects associated with the vaccination should be reported to your child's health care provider.
• Ask your child's health care provider about the risks, benefits and if Prevnar 13^® is right for your child.

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^®