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General information - rotavirus vaccine
Why is it important to vaccinate against rotavirus? Isn't the disease benign?
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.
Is it possible for adults to contract rotavirus? What are the symptoms in adults?
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 MMWR 2011;60:1456.
What are the recommendations for use of rotavirus vaccines?
Two rotavirus vaccines are available in the United States. RotaTeq (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 (GlaxoSmithKline) 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.
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.
How do the two rotavirus vaccines differ?
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.
Can RotaTeq (RV5; Merck) and Rotarix (RV1; GlaxoSmithKline) vaccines be used interchangeably? If so, what schedule should we follow?
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.
If we don't know which rotavirus vaccine an infant previously received, how should we complete the schedule?
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.
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?
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.
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?
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 in the package insert at http://us.gsk.com/products/assets/us_rotarix.pdf.
Can rotavirus vaccine be given via G-Tube? If so, is it okay to flush with normal saline or sterile water?
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.
A child received the first rotavirus vaccine and after a while he got the disease (laboratory confirmed). Should we continue the vaccine?
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.
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?
Yes. Rotavirus vaccine virus is shed during the first weeks after administration of rotavirus vaccine. Handwashing after diaper changing is always recommended.
Which infants should not receive rotavirus vaccine?
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 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) and infants with a history of intussusception.
Can rotavirus vaccine be given to an infant who has an immunosuppressed household contact?
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 Recommendations on Immunization, available at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf.
Can preterm infants receive rotavirus vaccine?
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.
Have these vaccines (RotaTeq or Rotarix) been associated with intussusception?
Large prelicensure clinical trials of both RotaTeq and Rotarix did not find an increased risk for intussusception among vaccine recipients. A large postlicensure 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. Additional information on this topic can be found on the FDA website at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm356758.htm.
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.
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?
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.
What are the storage and handling guidelines for rotavirus vaccine (RotaTeq and Rotarix)?
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.
Reviewed and revised August 2013
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