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| General information - rotavirus
vaccine |
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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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| What
are the recommendations for use of rotavirus vaccines? |
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| RotaTeq (by Merck) was licensed
in February 2006 and 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. A second rotavirus vaccine, Rotarix (by GlaxoSmithKline), was
licensed in April 2008 and is recommended as a 2-dose series at ages 2
and 4 months. ACIP recommendations for use of rotavirus vaccines are
available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm?s_cid=rr5802a1_e. 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 minimum interval between doses
of rotavirus vaccine is 4 weeks. 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 (RV5)
contains five reassortant rotaviruses developed from human and bovine
parent rotavirus strains; 3 doses are given in the series. Rotarix (RV1)
contains an attenuated human rotavirus strain; 2 doses are given in the
series. |
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| Now
that there are two licensed vaccines for rotavirus that have different
schedules, how can we keep track of which vaccine an infant might have
previously received? |
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| That may be difficult at first. The
generic abbreviation for the rotavirus vaccine was recently changed to
"RV" (it used to be "Rota"). CDC has also developed abbreviations to
distinguish the two RV vaccines. Rotarix is now abbreviated as RV1 and
RotaTeq as RV5. Immunization providers should use these new
abbreviations when recording the vaccine they administered. |
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| Can RotaTeq (RV5;
Merck) and Rotarix (RV1; GlaxoSmithKline) vaccines be used
interchangeably? If so, what schedule should we follow? Will giving one
formulation alter the schedule for giving the other? |
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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 RV5, 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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| 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 resource helpful: www.merckvaccines.com/rotateqProductPage_frmst.html. Click on
"Dosage and Administration," and scroll down for an educational video on
administration. You can also find a pictorial description of both
reconstitution and administration of Rotarix in the package insert at http://us.gsk.com/products/assets/us_rotarix.pdf. |
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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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| 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 (e.g.,
anaphylaxis) after a previous dose of rotavirus vaccine or to a vaccine
component. The oral applicator for Rotarix contains latex rubber so
infants with a severe (anaphylactic) allergy to latex should not be
given Rotarix; the RotaTeq dosing tube is latex-free. Rotavirus vaccine
is contraindicated in infants diagnosed with the rare disorder, Severe
Combined Immunodeficiency (SCID). |
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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
(e.g., 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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| Have
these vaccines (RotaTeq or Rotarix) been associated with intussusception? |
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| The clinical trial that led to licensure
of RotaTeq included 69,625 infants; the clinical trial that led to the
licensure of Rotarix included 63,225 infants. Neither of these trials
found evidence of an increased risk of intussusception in vaccine
recipients compared with placebo recipients. A post-licensure evaluation
of U.S. infants in the Vaccine Safety Datalink also found that the
number of cases of intussusception among infants who had received
RotaTeq was not greater than the number of cases expected to occur by
chance alone. |
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| Reviewed on 4/06/10 |
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