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| General information - rotavirus |
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| Why is
it important to vaccinate against rotavirus? Isn't the disease benign? |
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| Rotavirus is the most common cause of
severe gastroenteritis in infants and young children. The disease may
cause severe dehydrating diarrhea with vomiting and fever. Almost all
children are infected by age 5 years. Annually, rotavirus in the U.S. is
responsible for 3 million infections, more than 400,000 physician
visits, 160,000 emergency department visits, 55,000-70,000
hospitalizations, and between 20 and 60 deaths. |
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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. The first dose may be given as early as age 6 weeks. A second
rotavirus vaccine, Rotarix (by GlaxoSmithKline), was licensed on April
3, 2008. It is approved for oral administration as a 2-dose series to
infants at ages 2 and 4 months. The initial ACIP recommendations (issued
before the licensure of Rotarix) can be found at
www.cdc.gov/mmwr/PDF/rr/rr5512.pdf Following the licensure of
Rotarix, CDC issued provisional (adopted 6/25/2008) recommendations that
harmonize the two rotavirus vaccines; they can be found at
www.cdc.gov/vaccines/recs/provisional |
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| How do
the two rotavirus vaccines differ? |
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| The rotavirus vaccination series
consists of either two 1-mL doses of Rotarix (GSK) given at 2 and 4
months of age or three 2-mL doses of RotaTeq (Merck) given at 2, 4, and
6 months of age. CDC has revised its recommendations to make the
schedule less confusing: neither vaccine should be initiated in an
infant once the infant becomes age 15 weeks (i.e., is older than 14
weeks 6 days) and the series should be completed before the infant turns
8 months 0 days. The minimum interval between doses is 4 weeks. CDC's
provisional (adopted 6/25/2008) recommendations for rotavirus vaccine
are available at
www.cdc.gov/vaccines/recs/provisional |
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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 (a
monovalent vaccine containing a live, attenuated human G1P1A[8] virus),
and RotaTeq as RV5 (a pentavalent vaccine comprising 5 live reassortant
rotaviruses). 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 1 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(s) 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 you have any doubt about which
vaccine the infant previously received and the infant is at an age when
the vaccine can still be given, give a total of 3 doses of rotavirus
vaccine. |
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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 may 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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| If a
child has received all of the indicated doses of rotavirus vaccine on
schedule but doesn't get the final dose by age 8 months 0 days, should
we vaccinate or not? |
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| An infant should not receive any
rotavirus vaccine once she or he is age 8 months 0 days or older. |
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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 severe allergic reaction to any rotavirus vaccine
component or following a prior dose, has altered immunocompetence, has a
pre-existing chronic gastrointestinal disease or history of
intussusception, or has a moderate or severe acute illness at the time
of the clinic visit. 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. |
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| Can
preterm infants receive rotavirus vaccine? |
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| CDC recommends the vaccination of a
preterm infant if the infant is at least age 6 weeks, is being or has
been discharged from the hospital, and is clinically stable. |
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| What is
the evidence that these two rotavirus vaccines (RotaTeq or Rotarix) will
not be followed by intussusception? |
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| The clinical trial that led to licensure
of RotaTeq included more than 70,000 infants; the clinical trial that
led to the licensure of Rotarix included 63,225 infants. Neither of
these trials found any evidence of an increased risk of intussusception
in vaccine recipients. Subsequent studies of infants who have received
RotaTeq have found no increase in numbers of cases of intussusception
above what would normally be expected to occur. |
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| Reviewed on 10/09 |
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