| Rotavirus |
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| Disease Issues |
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| Why is it
important to vaccinate against rotavirus?
Isn't the disease benign? |
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| Before rotavirus
vaccines were available, rotavirus was the
most common cause of severe gastroenteritis in
infants and young children in the United
States
and worldwide. Almost all children were
infected by age 5 years. Before vaccine was
introduced in the United States, rotavirus was
responsible each year
for about 3 million episodes of gastroenteritis, 410,000 physician visits,
205,000–272,000 emergency department visits,
55,000–70,000 hospitalizations,
and between 20 and 60 deaths among children
younger than age 5 years. |
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| How is
rotavirus spread? |
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| Rotavirus is
contagious and the infection is usually spread
from person to person, through the fecal-oral
route. Fecal-oral transmission occurs when
bacteria or viruses found in the stool of one
person are swallowed by another person. This
can occur when small amounts of fecal matter
may be found on
surfaces such as toys, books, clothing, etc.
and on the hands of parents or child-care
providers; but are usually invisible.
Rotavirus may also be
transmitted through intake of fecally-contaminated
water or food or by respiratory droplets that
people sneeze, cough, drip, or exhale. Rates
of the illness
among children in developed and less developed
countries are similar. |
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| Is it possible
for adults to contract rotavirus? What are the
symptoms in adults? |
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| Yes. Rotavirus
infection of adults is usually asymptomatic
but may cause diarrheal illness. Outbreaks of
diarrheal illness caused by rotavirus have
been
reported, especially among elderly persons
living in retirement communities. For more
information on this issue see
www.cdc.gov/mmwr/pdf/wk/mm6042.pdf, page 1456. |
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| Where can I
get the most recent recommendations for the
use of rotavirus vaccine? |
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| Advisory
Committee on Immunization Practices (ACIP)
recommendations for use of rotavirus vaccines
are available at
www.cdc.gov/mmwr/PDF/rr/rr5802.pdf. |
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| What are the
recommendations for use of rotavirus vaccines? |
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| Two rotavirus
vaccines are available in the United States.
RotaTeq (RV5; Merck) is recommended for
routine oral administration for all infants as
a 3-dose
series. The usual schedule is at ages 2, 4,
and 6 months. Rotarix (RV1; GlaxoSmithKline)
is recommended as a 2-dose series at ages 2
and 4 months. |
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| The minimum
interval between doses of rotavirus vaccine is
4 weeks. The minimum age for the first dose is
6 weeks and the maximum age for dose #1 is
14 weeks 6 days. Vaccination should not be
initiated for infants age 15 weeks 0 days or
older because there are insufficient data on
the safety of dose #1
in older infants. The maximum age for the last
dose of rotavirus vaccine is 8 months and 0
days. |
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| How do the two
rotavirus vaccines differ? |
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| The two rotavirus
vaccine products differ in composition and
schedule of administration. RotaTeq was
approved by the Food and Drug Administration
(FDA) in 2006. It contains five reassortant
rotaviruses developed from human and bovine
parent rotavirus strains; 3 doses are given in
the series. Rotarix
was approved by the FDA in 2008 and contains
an attenuated human rotavirus strain; 2 doses
are given in the series. |
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| According to
the package inserts the maximum age for a dose
of RotaTeq is 32 weeks and the maximum age for Rotarix is 24 weeks. According to ACIP
recommendations the maximum age for a dose of
rotavirus vaccine is 8 months 0 days. Eight
months 0 days is older than age 24 weeks and
may be older
than age 32 weeks. Should I follow the package
labels or the ACIP recommendation? |
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| ACIP
recommendations and package inserts do not
always match. Occasionally, ACIP may use
different data to formulate its
recommendations, or try to
add flexibility to its recommendations (as was
the case in this situation), which results in
a recommendation different than the package
insert. Published
recommendations of national advisory groups
(such as ACIP or AAP's Committee on Infectious
Diseases) should be considered equally as authoritative as
those on the package insert. You should
consider 8 months 0 days as the maximum age
for a dose of rotavirus vaccine. |
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| Can RotaTeq
and Rotarix vaccines be used interchangeably?
If so, what schedule should we follow? |
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| ACIP recommends
that the rotavirus vaccine series be completed
with the same product whenever possible. However, vaccination should not be deferred
because the product used for a previous dose
is not available or is unknown. In these
situations, the provider should continue or
complete the series with
the product available. If any dose in the
series was RotaTeq, or the vaccine product is
unknown for any dose in the series, a total of
3 doses of rotavirus
vaccine should be administered. The minimum
interval between doses of rotavirus vaccine is
4 weeks. All doses should be administered by
age 8 months
and 0 days. |
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| A child
received the first rotavirus vaccine and later
got laboratory-confirmed rotavirus diarrhea.
Should we continue the vaccine? |
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| ACIP recommends
that infants who have had rotavirus
gastroenteritis before receiving the full
series of rotavirus vaccination should still
start or complete
the schedule according to the age and interval
recommendations because the initial rotavirus
infection might provide only partial
protection against
subsequent rotavirus disease. |
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| Can preterm
infants receive rotavirus vaccine? |
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| ACIP supports
vaccination of preterm infants according to
the same schedule and precautions as full-term
infants and under the following conditions: if
the
infant's chronological age meets the age
requirements for rotavirus vaccine (for
example, age 6 weeks to 14 weeks 6 days for
dose #1), the infant is
clinically stable, and the vaccine is
administered at the time of discharge from the
hospital or after discharge from the hospital. |
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| We have a
20-week-old infant who was born prematurely.
The infant has never received rotavirus
vaccine and is technically past the maximum
age for first
dose. Should we give rotavirus vaccine to this
infant? |
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| ACIP recommends
vaccination of preterm infants according to
the same schedule and precautions as full-term infants. In preterm infants (as in full-term
infants), the maximum chronological age for
the first dose is 14 weeks 6 days. Vaccination
should not be initiated for infants aged 15
weeks 0 days or
older because of insufficient data on safety
of dose 1 of rotavirus vaccine in older
infants. For more information, see page 19 of ACIP's recommendations
on rotavirus vaccination, available at
www.cdc.gov/mmwr/PDF/rr/rr5802.pdf. |
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| If we don't
know which rotavirus vaccine an infant
previously received, how should we complete
the schedule? |
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| If the product
used for a previous dose is unknown, and the
infant is at an age when the vaccine can still
be given, give a total of 3 doses of rotavirus
vaccine. All doses should be administered by
age 8 months and 0 days. |
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| If the first
dose of rotavirus vaccine is inadvertently
given to a child age 15 weeks 0 days or older,
should the series be continued? |
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| Infants for whom
the first dose of rotavirus vaccine was
inadvertently administered at age 15 weeks or
older should receive the remaining doses of
the
series at the routinely recommended intervals.
Timing of the first dose should not affect the
safety and efficacy of the remaining doses.
Rotavirus vaccine
should not be given after age 8 months 0 days
even if the series is incomplete. |
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| Our experience
has been that many babies who receive the oral
rotavirus vaccine spit a lot of it out. We know not to give them more. But how can we be
sure that the little they ingest is enough? |
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| Try to follow
general guidelines for oral administration of
liquid vaccines. First, give this vaccine at
the beginning of the office visit, while the
baby is still
happy, and before you administer injections or
perform other procedures. Second, make every
effort to aim the dropper containing the
vaccine down one
side and toward the back of the child's mouth.
Don't put the dropper so far back that you gag
the child. You may find the following
information from the
RotaTeq manufacturer helpful:
www.merckvaccines.com/Products/RotaTeq/Pages/dosageandadministration.
You can also find a pictorial description of
both reconstitution and administration of
Rotarix at
www.gsksource.com/pharma/content/gsk/source/us/en/brands/rotarix/pi/dosing.html. |
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| Can rotavirus
vaccine be given via G-Tube? If so, is it okay
to flush with normal saline or sterile water? |
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| The manufacturer
has not addressed this issue but CDC considers
administration of rotavirus vaccine via gastrostomy tube to be acceptable practice.
There should be no problem flushing the tube
after vaccine has been administered. |
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| Is it okay to
administer rotavirus vaccine and immune
globulin at the same time? |
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| Yes. The
effectiveness concerns with
antibody-containing blood products (ACBP) do
not apply to rotavirus vaccine, since it is
administered orally and
replication of the vaccine virus occurs in the
GI tract, "separate" from the site of the ACBP.
Note that the child should be carefully
screened for other
potential contraindications or precautions to
vaccination since administration of immune
globulin could indicate immunosuppression. |
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| We received a
report of an infant who received rotavirus
vaccine intramuscularly rather than orally. Is this dose valid? If not, when should it be
repeated? |
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| The rotavirus
vaccine dose given by the intramuscular route
is not valid and should be repeated by the
oral route as soon as possible. In a review of
such
rotavirus vaccine administration errors, there
usually were not adverse reactions, and those
documented were limited to local reactions and
general, brief
irritability. See
www.cdc.gov/mmwr/pdf/wk/mm6304.pdf,
page 81, for more information. |
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| Please take steps
to ensure that such vaccine administration
errors are avoided in the future. This event
should be reported to the Vaccine Adverse
Event
Reporting System at
vaers.hhs.gov even if an
adverse reaction does not result from it. |
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| Should we warn
parents/guardians to wash their hands after
diaper changes, which they should be doing anyway, after the baby has received rotavirus
vaccine? |
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| Yes. Rotavirus
vaccine virus is shed during the first weeks
after administration of rotavirus vaccine.
Handwashing after diaper changing is always
recommended. |
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| Which infants
should not receive rotavirus vaccine? |
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| Do not give
rotavirus vaccine to an infant who has a
history of a severe allergic reaction (for
example, anaphylaxis) after a previous dose of
rotavirus
vaccine or to a vaccine component. The oral
applicator for Rotarix contains natural latex
rubber so infants with a severe (anaphylactic)
allergy to latex
should not be given Rotarix; the RotaTeq
(Merck) dosing tube is latex-free. Rotavirus
vaccine is contraindicated in infants with the
rare disorder severe
combined immunodeficiency (SCID) and in
infants with a history of intussusception. |
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| Practitioners
should consider the potential risks and
benefits of administering rotavirus vaccine to
infants with known or suspected altered
immunocompetence, including those whose
mothers received immunosuppressive biologics
(such as infliximab) during pregnancy.
Consultation with an
immunologist or infectious diseases specialist
is advised. |
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| Children and
adults who are immunocompromised because of
congenital immunodeficiency, hematopoietic transplantation, or solid organ
transplantation
sometimes experience severe or prolonged
rotavirus gastroenteritis. However, few safety
or efficacy data are available for the
administration of rotavirus
vaccine to infants who are immunocompromised
or potentially immunocompromised, including 1)
infants with primary and acquired
immunodeficiency,
cellular immunodeficiency, and
hypogammaglobulinemia and dysgammaglobulinemia;
2) infants with blood dyscrasias, leukemia,
lymphomas, or other
malignant neoplasms affecting the bone marrow
or lymphatic system; 3) infants on
immunosuppressive therapy (including high-dose systemic
corticosteroids); and 4) infants who are
HIV-exposed or infected. |
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| A woman in our
practice received infliximab (Remicade,
Janssen Pharmaceuticals) for treatment of Crohn's Disease while she was pregnant. Should
we
modify her infant's vaccination schedule
because of this treatment? |
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| Infliximab is an
IgG monoclonal antibody that neutralizes the
biological activity of tumor necrosis
factor-alpha. Like other IgG antibodies
infliximab crosses
the placenta. Infliximab has been detected in
the blood of infants up to 6 months following
birth. Consequently, these infants may be at
increased risk of
serious infection. |
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| Neither ACIP nor
CDC provides specific guidance on this issue
because there are few data on safety or
efficacy in children exposed to potentially
immunosuppressive biologics during pregnancy.
As noted above, practitioners should consider
the potential risks and benefits of
administering rotavirus
vaccine to infants with known or suspected
altered immunocompetence. Consultation with an
immunologist or infectious diseases specialist
is advised. |
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| The manufacturer
recommends that live vaccines (rotavirus and
BCG) be deferred for at least six months after birth for infants whose mothers received
infliximab during pregnancy. Hence, if a
practitioner follows the manufacturer’s
recommendation the child would not be eligible
to receive rotavirus vaccine
because according to ACIP guidelines the
rotavirus vaccine series should not to be
started after age 15 weeks 0 days. |
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| Inactivated
vaccines should be given on schedule. |
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| Can rotavirus
vaccine be given to an infant who has an
immunosuppressed household contact? |
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| Having an
immunocompromised household contact is not
usually a reason for delaying routine
vaccination for others in the household.
Rotavirus vaccine
should be administered to susceptible
household contacts and other close contacts of
immunocompromised patients when indicated. All
members of the
household should wash their hands after
changing the diaper of an infant. This
minimizes rotavirus transmission from an
infant who received rotavirus
vaccine. Additional information on this topic
can be found in the ACIP General Best Practice
Guidelines for Immunization, available at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/immunocompetence.html. |
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| What adverse
reactions have been reported following
rotavirus vaccines? |
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| In the RotaTeq
clinical trials in the first week after any
dose vaccine recipients had a small but
statistically significant increased rate of
diarrhea (18.1% in
the RotaTeq group, 15.3% in the placebo group)
and vomiting (11.6% in the RotaTeq group, 9.9%
in the placebo group). During the 42-day
period
following any dose, statistically
significantly greater rates of diarrhea,
vomiting, otitis media, nasopharyngitis and
bronchospasm occurred in RotaTeq
recipients compared with placebo recipients. |
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| In the Rotarix
clinical trials, in the first week after
vaccination, Grade 3 (i.e., those that
prevented normal everyday activities) cough or
runny nose
occurred at a slightly but statistically
higher rate in the Rotarix group (3.6 %) compared with placebo group (3.2%). During the
31 day period after
vaccination, these unsolicited adverse events
occurred at a statistically higher incidence
among vaccine recipients: irritability (11.4%
in Rotarix group,
8.7% in placebo group) and flatulence (2.2% in
Rotarix group, 1.3% in placebo group). |
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| In clinical
trials of both vaccines the occurrence of
intussusception was studied very carefully
(see next Q&A). |
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| Have the
current rotavirus vaccines been associated
with intussusception? |
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| Large
pre-licensure clinical trials of both RotaTeq
and Rotarix did not find an increased risk for
intussusception among vaccine recipients. A
large post-licensure study of more than 1.2 million
rotavirus vaccine recipients found a very
small increased risk of intussusception (1 to
1.5 additional cases of
intussusception per 100,000 vaccinated infants) in the 7 to 21 days following the
first dose. No increased risk of
intussusception was found after the
second or third doses. CDC and the Food and
Drug Administration (FDA) continue to believe
that the benefits of rotavirus vaccination
outweigh the risks
associated with vaccination and that routine
vaccination of infants should continue. |
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| A study conducted
by the CDC Vaccine Safety Datalink (VSD)
between May 2006 to February 2010 found no increased risk of intussusception following
vaccination with RotaTeq. However, the study
indicated an increased risk of intussusception
following dose 1 and dose 2 of Rotarix. Over
200,000 doses of
Rotarix have been given to children monitored
in VSD. Based on these findings, one case of
intussusception would be expected for approximately each
20,000 children who are fully vaccinated. |
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| What are the
storage and handling guidelines for rotavirus
vaccine (RotaTeq and Rotarix)? |
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| Both vaccines
should be stored at refrigerator temperature
and protected from light. Do not administer
the vaccine if it has been frozen or exposed
to
freezing temperatures. |
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ACIP Recommendations
Vaccine Information Statements 
