by Steve Schutz, MD
Rotavirus is a leading cause of
severe acute gastroenteritis in
infants and young children,
resulting in an estimated 55,000 to
70,000 hospitalizations, more than
200,000 emergency room visits and
approximately 400,000 visits to doctor’s
offices per year in the United
States. It is highly prevalent and contagious,
infecting nearly all children by
age five, many more than once.
Rotavirus is similar to flu in that
there are different types of rotavirus.
Many of these rotavirus serotypes can
circulate simultaneously, but their distribution
can vary from year to year
and region to region.
A vaccine is available for infants that
helps prevent rotavirus disease caused
by common circulating serotypes G1,
G2, G3 and G4, which have been
responsible for approximately 90 percent
of rotavirus G serotypes identified
in the United States.
I recommend that parents talk to
their healthcare provider about rotavirus
vaccination, to see if vaccination
is appropriate for their infants.
One rotavirus vaccine available in
the United States is RotaTeq® (rotavirus
vaccine, live, oral, pentavalent).
RotaTeq is indicated for the prevention
of rotavirus gastroenteritis in infants
and children caused by the serotypes
G1, G2, G3, and G4 when administered
as a three-dose series to infants
between the ages of six to 32 weeks.
The first dose of RotaTeq should be
administered between six and 12
weeks of age, with the subsequent
doses administered at 4- to 10-week
intervals. The third dose should not
be given after 32 weeks of age.
RotaTeq was approved by the FDA
on February 3, 2006.
Select Safety Information
About RotaTeq
• RotaTeq should not be administered
to infants with a demonstrated history
of hypersensitivity to any component
of the vaccine.
• No safety or efficacy data are available
for the administration of
RotaTeq to infants who are potentially
immunocompromised, including
those who have received
blood products within 42 days
of vaccination.
• More than 71,000 infants were evaluated
in three placebo-controlled clinical
trials. Serious adverse events occurred
in 2.4 percent of recipients of
RotaTeq when compared to 2.6 percent
of placebo recipients within the
42-day period of a dose of RotaTeq.
Hematochezia, reported as a serious
adverse event for RotaTeq compared to
placebo, was less than 0.1 percent vs.
less than 0.1 percent. The most frequently
reported serious adverse
events for RotaTeq compared to
placebo were bronchiolitis (0.6 percent
vs. 0.7 percent), gastroenteritis
(0.2 percent vs. 0.3 percent), pneumonia
(0.2 percent vs. 0.2 percent), fever
(0.1 percent vs. 0.1 percent), and urinary tract infection (0.1 percent vs.
0.1 percent).
• In a subset of more than 11,000
infants in these trials, the presence
of adverse events was reported for
42 days after each dose. Fever was
observed at similar rates in vaccine
and placebo recipients (42.6 percent
vs. 42.8 percent). Adverse events
that occurred at a statistically higher
incidence within 42 days of any
dose among recipients of RotaTeq as
compared with placebo recipients
were diarrhea (24.1 percent vs. 21.3
percent), vomiting (15.2 percent vs.
13.6 percent), otitis media (14.5
percent vs. 13.0 percent), nasopharyngitis
(6.9 percent vs. 5.8 percent),
and bronchospasm (1.1 percent
vs. 0.7 percent).
• In post-marketing experience, cases
of intussusception have been
reported in temporal association
with RotaTeq.
• Vaccination with RotaTeq may not
result in complete protection in
all recipients.
• Prescribing information for RotaTeq
follows and is also available at www.rotateq.com
Rotavirus Fact Sheet
About Rotavirus
Rotavirus is a leading cause of severe acute gastroenteritis in infants and
young children. It is highly prevalent and contagious, infecting nearly all
children by age five, many more than once.
Rotavirus symptoms vary but typically include fever, vomiting, and
watery diarrhea that can be profuse and can persist for three to nine days.
In a severe case, more than 20 episodes of diarrhea or vomiting could
occur in 24 hours. These symptoms can lead to loss of body fluids, putting
an infant at risk of severe dehydration.
Severity of rotavirus disease can be unpredictable and ranges from
asymptomatic infection to severe, dehydrating gastroenteritis. Severe disease
occurs primarily in young children, most commonly between six and
24 months of age.
Because rotavirus serotypes can vary from season to season and region
to region, it is difficult to predict the serotype to which a child will
be exposed.
Rotavirus is similar to flu in that there are different types of rotavirus.
Many of these rotavirus serotypes can circulate simultaneously in a given
region, and these serotypes can vary from year to year. Historically, common
circulating serotypes (G1, G2, G3 and G4) have been responsible for
approximately 90 percent of rotavirus disease in the United States.
In the United States and other countries with a temperate climate,
rotavirus has a winter-spring seasonal pattern and occurs most often from
November to April.
Global and U.S. Impact of Rotavirus
In the United States, rotavirus is responsible for an estimated 55,000 to
70,000 hospitalizations, more than 200,000 emergency room visits and
approximately 400,000 visits to doctor's offices per year among children
under five.
Rotavirus infection accounts for approximately one-third of the cases of
severe diarrhea requiring hospitalizations worldwide.
However, the incidence of rotavirus disease was observed to be similar
in both industrialized and developing countries, suggesting that adequate control may not be achieved by improvements
in water supply, hygiene, and sanitation.
Although the incidence of illness caused by rotavirus is
similar in developing and developed countries, the mortality
caused by rotavirus infection is significantly greater
in developing countries.
Worldwide, nearly 600,000 children under five, approximately
one child per minute, die from rotavirus every year,
with 80 percent of deaths occurring in low-income countries.
In the United States, there are approximately 20 to 60
deaths per year among children under five.
Overview of RotaTeq
• RotaTeq (rotavirus vaccine, live, oral, pentavalent),
approved by the U.S. Food and Drug Administration
(FDA) on February 3, 2006, is the only pentavalent
vaccine available in the United States to help prevent
rotavirus gastroenteritis in infants and children.
Rotavirus gastroenteritis is a leading cause of severe
dehydrating diarrhea in infants and young children.
• RotaTeq is indicated for the prevention of rotavirus
gastroenteritis in infants and children caused by the
serotypes G1, G2, G3, and G4 when administered as a
three-dose series to infants between the ages of six to
32 weeks.
• In the United States, infants are now routinely receiving
RotaTeq as recommended by the Advisory Committee
on Immunization Practices (ACIP) and the American
Academy of Pediatrics (AAP).
• RotaTeq can be easily incorporated into the routine childhood vaccination schedule during the two, four,
and six month well baby visits. The vaccination series
consists of three, ready-to-use liquid doses requiring
no reconstitution.
• RotaTeq is approved for use in more than 60 countries.
• RotaTeq is included in all 55 projects of the Centers for
Disease Control and Prevention (CDC) Vaccine for
Children (VFC) program, which provides vaccines to
children who are Medicaid-eligible, uninsured, underinsured
or Native American.
• In a pre-licensure clinical trial, RotaTeq was shown to
help protect against rotavirus gastroenteritis caused by
G1, G2, G3 and G4 serotypes through two rotavirus
seasons. An additional study is evaluating its efficacy
through the third season.
• Many children can get infected more than once with
rotavirus during the first few years of life with the same
or different serotype.
• RotaTeq helps prevent rotavirus gastroenteritis caused
by common circulating serotypes G1, G2, G3, and G4,
which have been responsible for approximately 90 percent
of rotavirus disease in the United States.
• Overall, G2 has been the second most common
serotype found in the United States over the last 15
years, although rotavirus serotype distribution has
varied by region and year.
• From 1996 to 1999, G2 accounted for approximately
11 percent of identified G serotypes in the United States.
• A recent study conducted during the 2005-2006
rotavirus season in Philadelphia revealed a markedly
increased frequency of G2 cases, with 37 percent of
275 samples analyzed testing positive for G2.
Efficacy & Safety
In phase III clinical trials, including the Rotavirus
Efficacy and Safety Trial (REST), one of the largest prelicensure
vaccine clinical trials ever conducted, RotaTeq:
• demonstrated 98 percent efficacy against severe cases of
rotavirus gastroenteritis and 74 percent of all rotavirus
gastroenteritis cases caused by rotavirus serotypes G1,
G2, G3 and G4 through the first rotavirus season postvaccination
(n=5673); and
• reduced hospitalizations by 96 percent (n=68,038) and
Emergency Department visits by 94 percent (n=57,134)
through two years following the third dose.
The incidence of serious adverse events within six
weeks of a dose of RotaTeq was comparable among
vaccine and placebo recipients in phase III clinical trials
including REST. x
References
RotaTeq PI, p.1
Bernstein DI, Ward RL. Rotaviruses. In: Feigin RD, Cherry
JD, eds. Textbook of Pediatric Infectious Diseases. 5th ed.
Vol. 2. Philadelphia, Pa: Saunders; 2004;4:2110- 2133
Staat MA, Azimi PH, Berke T. Clinical presentations of
rotavirus infection among hospitalized children. Pediatr
Infect Dis J. 2002;21:221–227.
Matson DO. Rotaviruses. In: Long SS, Pickering LK, Prober
CG, eds. Principles and Practice of Pediatric Infectious
Diseases. 2nd ed. Philadelphia, Pa: Elsevier–Health
Sciences Division; 2002:1104–1110.
Clark HF, Offit PA. Pediatr Ann. 2004;33:536–543.
Cornell SL. Confronting the consequences of rotavirus:
Diarrhea and dehydration. Adv Nurse Pract. 1999;5:41-44.
Raebel MA, Ou BS. Rotavirus disease and its prevention in infants
and children. Pharmacotherapy.
1999;19:1279–1295.
Bernstein DI, Ward RL. Rotaviruses. In: Feigin RD, Cherry,
JD eds. Textbook of pediatric infectious diseases. 5th ed.
vol. 2. Philadelphia: Saunders, 2004:2110-2133.
Bernstein DI, Ward RL. Rotaviruses. In: Feigin RD, Cherry
JD, eds. Textbook of Pediatric Infectious Diseases. 5th ed.
Vol. 2. Philadelphia, Pa: Saunders; 2004;4:2110–2133.
Kapikian AZ, Hoshino Y, Chanock RM. In: Knipe DM,
Howley PM, Griffin DE, et al, eds. Fields Virology. 4th
ed. Philadelphia, Pa: Lippincott Williams & Wilkins;
2001:1787–1825.
Parashar UD, Hummelman EG, Bresee JS et al. Global illness
and deaths caused by rotavirus disease in children.
Emerging infectious Diseases. 2003;9:565-572.
Griffin DD, et al. Surveillance of Rotavirus Strains in the
United States: Identification of Unusual Strains. Journal
of Clinical Microbiology, July 2000: 38(7):2784-2787.
Centers for Disease Control and Prevention, Rotavirus
homepage, About Rotavirus. Found at: http://www.cdc.
gov/rotavirus/about_rotavirus.htm
National Immunization Program. Rotavirus. Found at:
http://www.cdc.gov/nip/diseases/rota/rota-faqs.htm
Centers for Disease Control and Prevention. Found at:
http://www.cdc.gov/ncidod/eid/vol4no4/parashar.htm
Parashar U, Gibson C, Bresee J, Glass R. http://www.path.
org/vaccineresources/files/Rotavirus_severe_childhood_
diarrhea.pdf. Rotavirus and severe childhood diarrhea.
Emerging Infectious Diseases. 2006; 12(2):304-306.
Center for Disease Control and Prevention. Found at:
http://www.immunize.org/vis/rota_06.pdf
