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FREQUENTLY ASKED QUESTIONS ABOUT
PREVNAR 13 FOR PEDIATRIC USE
About Prevnar 13®
What is Prevnar 13®?
Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine
[Diphtheria CRM197 Protein]) is a vaccine approved by the
U.S. Food and Drug Administration (FDA) for use in children
6 weeks through 5 years of age for the prevention of invasive
disease caused by 13 strains of Streptococcus pneumoniae
(S. pneumoniae) (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
and 23F).1
What are the common side effects
associated with Prevnar 13?
The most common side effects are redness, swelling and
tenderness at the injection site, fever, decreased appetite,
irritability, increased sleep, and decreased sleep.1
Why was there a need for Prevnar 13
when Prevnar was already available?
Prevnar® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) was the first pneumococcal conjugate
vaccine (PCV) introduced to help protect infants and young
children against invasive pneumococcal disease (IPD) and
otitis media caused by seven strains of pneumococcus (4, 6B,
9V, 14, 18C, 19F and 23F).
Prevnar has had a substantial impact on public health where
it has been routinely used, dramatically reducing the rate
of IPD in infants and young children caused by the seven
serotypes in the vaccine.2 Despite this significant reduction, invasive disease due to serotypes not included in
Prevnar have been increasing in prevalence in the
U.S. In particular, serotype 19A is the most common cause of IPD among children younger than
5 years of age in the U.S. and is often antibiotic resistant.3,4
Prevnar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C,
19F, and 23F) in Prevnar, plus six additional serotypes (1, 3,
5, 6A, 7F, and 19A). Together, these 13 serotypes, including
19A, are responsible for the majority of remaining invasive
pneumococcal disease observed in infants and young
children in the U.S.3 Prevnar 13 does not provide 100%
protection against vaccine serotypes or protect against
nonvaccine serotypes.1
What is the dosing schedule
for Prevnar 13?
The Centers for Disease Control and Prevention (CDC)
recommends that children 2 months through 59 months of age
receive Prevnar 13.5 Both the CDC recommendations and the
FDA approved label include the following:
•For infants and toddlers, Prevnar 13 is to be administered
as a four-dose series at 2, 4, 6, and 12-15 months of age.1
•Children who have received one or more doses of Prevnar
may transition to Prevnar 13 to complete the four-dose
immunization series.1
•Children 15 months to 5 years of age who have received
four doses of Prevnar may receive one dose of Prevnar 13
to elicit immune responses to the six additional serotypes.1
The immune responses induced by the latter two Prevnar 13
schedules may result in lower antibody concentrations for the
six additional serotypes (1, 3, 5, 6A, 7F, and 19A) compared
to antibody concentrations following four doses of Prevnar 13
(given at 2, 4, 6, and 12 to 15 months).1
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Can a child receive Prevnar 13 if he or she
already finished his or her vaccination
schedule with Prevnar?
Children 15 months to 5 years of age who have received four
doses of Prevnar may receive one dose of Prevnar 13 to help
protect children against the six additional serotypes that can
cause IPD, including increasingly drug-resistant serotype 19A.1
The immune responses induced by this Prevnar 13 catch-up
schedule may result in lower antibody concentrations for
the six additional serotypes (types 1, 3, 5, 6A, 7F, and 19A)
compared to antibody concentrations following four doses of
Prevnar 13 (given at 2, 4, 6, and 12 to 15 months).1
Can Prevnar 13 be co-administered with
other routine pediatric vaccines?
In clinical trials, Prevnar 13 was effectively administered
concomitantly with the following U.S.–licensed vaccines*:
Pediarix™ and ActHIB® for the first three doses and with
PedvaxHIB®, M-M-R® II, and Varivax® or ProQuad® and
VAQTA® for dose 4. Based on limited data, responses to
mumps and rubella antigens in Prevnar 13 recipients were
similar to those in Prevnar recipients.1
*These brands are trademarks of their respective owners.
What studies support the use of Prevnar 13?
The clinical trial program for Prevnar 13 comprised 13
Phase 3 studies involving more than 7,000 children worldwide
of which 4729 received at least one dose of Prevnar 13.6 Data
from the Phase 3 trials support the use of Prevnar 13 for the
prevention of invasive pneumococcal disease in infants
and young children.1
Is there a federally funded program
for Prevnar 13?
The Vaccines for Children (VFC) program is a federally funded
program that provides vaccines at no cost to children who
might not otherwise be vaccinated because of inability to
pay. Children who are eligible under the VFC program are
entitled to receive pediatric vaccines that are recommended
by the CDC.
Where can I get more information?
Parents can talk to their child’s health care provider or visit
www.prevnar13.com or www.cdc.gov/vaccines.
About Invasive Pneumococcal
Disease (IPD)
What is invasive pneumococcal disease?
IPD occurs when bacteria invade parts of the body that are
normally free from bacteria, such as blood or spinal fluid, and
includes bacteremia (bacteria in the blood) and meningitis
(infection of the tissues surrounding the brain and spinal cord).7
Which factors could increase a child’s risk
of IPD?
There are several factors that may increase a child’s risk of
IPD, including the following:
•Age: Recommendations from the CDC state that
children younger than 2 years of age are at greater risk
of developing IPD.8
•Group child care attendance: Studies conducted in
the U.S. and Finland have found that children younger
than 2 years of age who attend daycare are at greater
risk for contracting IPD. Additional U.S. studies indicated
that daycare attendance in children aged 24 to 48
months led to increased incidence of IPD.8,9
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How does IPD spread?
Pneumococcal bacteria are spread by exposure to respiratory
droplets – including coughing and sneezing – from a person
who is infected with or carrying the bacteria.7
Can IPD infections be treated with
antibiotics?
While pneumococcal infections may be treated with antibiotics
like penicillin, antibiotic resistance of S. pneumoniae is an
increasing problem.10 This means that many cases of IPD are
difficult to treat, making prevention even more important.
Vaccines are valuable to public health, and may offer protection
against IPD.11
What should people do to help protect
their children against IPD?
The most effective preventive measure against IPD is vaccination. Parents should discuss IPD vaccination and how best
to help protect their children against IPD with their health
care provider.
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® (Pneumococcal 7-valent Conjugate Vaccine
[Diphtheria CRM197 Protein]), 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 and
benefits of Prevnar 13®. Only a health care provider can
decide if Prevnar 13® is right for your child.
Please see accompanying full Prescribing Information.
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References
1.
Prevnar 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) Prescribing Information,
Wyeth Pharmaceuticals Inc.
2. Pilishvili T, Lexau C, Farley MM, et al; for the Active Bacterial Core Surveillance/Emerging Infections Program Network.
Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201:32-41.
3. Centers for Disease Control and Prevention. Invasive pneumococcal disease in young children before licensure of 13-valent
pneumococcal conjugate vaccine – U.S., 2007. MMWR. 2010;59(9):253-257.
4. Kyaw MH, Lynfield R, Schaffner W, et al. Effect of introduction of the pneumococcal conjugate vaccine on drug-resistant
Streptococcus pneumoniae. N Engl J Med. 2006;354:1455-1463.Moore MR, Gertz RE Jr, Woodbury RL, et al. Population
snapshot of emergent Streptococcus pneumoniae serotype 19A in the U.S., 2005. J Infect Dis. 2008; 197:1016-1027.
5. Centers for Disease Control and Prevention. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and
recommendations for use among children — Advisory Committee on Immunization Practices (ACIP), 2010.
MMWR. 2010;59(9):258-261.
6.
Data on file. Pfizer Inc., New York, NY. [PCV13 ISS. Clinical Summary, Summary of Clinical Safety. 1-105.]
7.
Centers for Disease Control and Prevention. Pneumococcal disease. In: Atkinson W, Wolfe S, Hamborsky J, eds. Epidemiology
and Prevention of Vaccine-Preventable Diseases. 12th ed. Washington, DC: Public Health Foundation; 2011:233-248.
http://www.cdc.gov/vaccines/pubs/pinkbook/pink-chapters.htm.
8.
Centers for Disease Control and Prevention. Prevention of pneumococcal disease: recommendations of the Advisory
Committee on Immunization Practices (ACIP). MMWR. 1997;46(RR-08):1-24.
9.
Levine OS, Farley M, Harrison LH, et al, for the active bacterial core surveillance team. Risk factors for invasive pneumococcal
disease in children: A population-based case-control study in North America. Pediatrics. 1999;103:1-5.
10. Jones RN, Sader HS. Declining antimicrobial susceptibility of Streptococcus pneumoniae in the U.S.: report from the SENTRY
Antimicrobial Surveillance Program (1998-2009). Diag Microbiol Infect Dis. 2010;68:334-336.
11. Centers for Disease Control and Prevention. Vaccines & Immunizations: How vaccines prevent disease.
http://www.cdc.gov/vaccines/vac-gen/howvpd.htm.
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