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Rotavirus Vaccine - Questions & Answers

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What vaccines against rotavirus are available in the United States?

There are two licensed rotavirus vaccines in the United States: RotaTeq®, produced by Merck, and Rotarix®, produced by GlaxoSmithKline.

How is the vaccine given?

Rotavirus liquid vaccines are given by mouth (orally) to young infants.

At what age should children receive rotavirus vaccine?

RotaTeq® is administered in a 3-dose series, with doses administered at ages 2, 4, and 6 months. Rotarix® is administered in a 2-dose series, with doses administered at ages 2 and 4 months. The minimum age for dose 1 of rotavirus vaccine is 6 weeks; the maximum age for dose 1 is 14 weeks and 6 days. Vaccination should not be initiated for infants aged 15 weeks and 0 days or older because of insufficient data on safety of dose 1 of rotavirus vaccine in older infants. The minimum interval between doses of rotavirus vaccine is 4 weeks; no maximum interval is set. All doses should be administered by age 8 months and 0 days.

How well does rotavirus vaccine work to prevent rotavirus disease?

Efficacy studies have demonstrated that rotavirus vaccine is 85%-98% protective against severe rotavirus disease and 74%-87% protective against rotavirus disease of any severity in the first year after vaccination.

For full details, consult the MMWR article dated February 6, 2009 (Volume 58): Prevention of Rotavirus Gastroenteritis Among Infants and Children.

Can children get rotavirus vaccine when they are breastfeeding?

Yes. Children who are being breastfed should get rotavirus vaccine on schedule.

Who should not be vaccinated?

Your healthcare provider is the best source of information on the benefits and risks of vaccines. Before your child receives a dose of any vaccine, discuss with your healthcare provider any health problems that your child may have and any medications that your child is currently taking or has been prescribed. Also, discuss any concerns you might have about vaccination. Infants who are allergic to any of the ingredients of the vaccine or who have an allergic reaction after getting a dose of the vaccine should not be vaccinated. Tell your doctor about any allergies your child has. Infants diagnosed with severe combined immunodeficiency syndrome (SCID) should not receive rotavirus vaccine.

There may be other children who should not receive the vaccine, so talk with your doctor if your child has any chronic disease.

Can the vaccine be given with other vaccines?

Rotavirus vaccine can be administered together with DTaP vaccine, Hib vaccine, IPV, hepatitis B vaccine, and pneumococcal conjugate vaccine. Available evidence suggests that rotavirus vaccine does not interfere with the immune response to these vaccines. The infant's immune response to influenza vaccine administered at the same time as rotavirus vaccine has not been studied. However, ACIP (Advisory Committee on Immunization Practices) has recommended previously that an inactivated vaccine (e.g., inactivated influenza vaccine) may be administered either simultaneously or at any time before or after a different inactivated vaccine or live vaccine (e.g., rotavirus vaccine).

Does the vaccine contain mercury or thimerosal?

No. The vaccines do not contain thimerosal or any other preservative.

How can I report a serious side effect of RotaTeq®, Rotarix®, or other vaccine?

Adverse reactions and other problems related to vaccines should be reported to the Vaccine Adverse Event Reporting System, which is maintained by FDA and CDC. For a copy of the vaccine reporting form, call 1-800-822-7967 or report online to www.vaers.hhs.gov

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