New Drug Reviews

Rotavirus Vaccine, Live, Oral, Pentavalent (RotaTeq) for Prevention of Rotavirus Gastroenteritis


Am Fam Physician. 2006 Sep 15;74(6):1014-1015.


Rotavirus immunization is back with a live, oral, pentavalent vaccine (RotaTeq) that targets the strains responsible for more than 90 percent of rotavirus gastroenteritis in the United States.1 The pentavalent rotavirus vaccine should not be confused with either the monovalent vaccine (Rotatrix) that is licensed in Central and South America or the earlier tetravalent rotavirus vaccine (RotaShield) that was withdrawn from use because of an increased risk of intussusception. Rotavirus pentavalent vaccine is given as a three-dose series with the first dose given to infants between six to 12 weeks of age and the last dose administered by 32 weeks of age.

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NameStarting dosageDose formApproximate cost*

Rotavirus pentavalent vaccine (RotaTeq)

2-mL orally at two, four, and six months of age


$243 ($81 per dose)

*—Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2006.

NameStarting dosageDose formApproximate cost*

Rotavirus pentavalent vaccine (RotaTeq)

2-mL orally at two, four, and six months of age


$243 ($81 per dose)

*—Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2006.


The safety of rotavirus pentavalent vaccine has been demonstrated in studies that have included approximately 35,000 infants.14 Unlike the earlier tetravalent rotavirus vaccine, this pentavalent vaccine has not been associated with an increased risk of intussusception in prelicensure trials.14 Statements from the manufacturer and the Advisory Committee on Immunization Practices (ACIP) are unclear regarding the vaccination of infants who are immunocompromised and infants who have close contact with immunodeficient persons.13

The safety of rotavirus pentavalent vaccine during pregnancy has not been established; therefore, the vaccine should not be given to women who are pregnant or lactating. It is safe to give to infants living in households with pregnant women.2,3 Rotavirus pentavalent vaccine does not contain any preservatives, thimerosal, or egg products.13 Absolute contraindications include a history of serious allergic reaction to a previous dose of vaccine or history of severe hypersensitivity to any vaccine component.1,3


Rotavirus pentavalent vaccine is well tolerated. Common side effects such as diarrhea, vomiting, otitis media, nasopharyngitis, and bronchospasm occur but only at a slightly higher rate than with placebo.14 The manufacturer has not commented on the product’s taste or the likelihood that a dose will be regurgitated. If, for any reason, a dose is incompletely administered, a replacement dose is not recommended.1


Approximately 1.4 to 2.5 percent of children in the United States will be hospitalized for treatment of rotavirus infection. In healthy infants who receive the vaccine series as labeled, hospitalization and emergency care for rotavirus gastroenteritis will be decreased by 95 percent.4 In clinical practice, about 94 infants have to be immunized to prevent one rotavirus gastroenteritis episode requiring emergency or hospital care (number needed to treat = 94; 95% confidence interval, 84 to 105).4

Immunization with rotavirus pentavalent vaccine decreases office visits for rotavirus gastroenteritis and decreases lost work days by parents or guardians. Protection lasts at least one year and is 88 percent effective against severe rotavirus disease in the second year following immunization, covering the period when infants are most susceptible.1,4 The three-vaccine series is recommended by the ACIP.2


Rotavirus pentavalent vaccine costs approximately $243 for the three-part series.1 It is coded as a preventive service and will likely be reimbursed by third party insurance plans.5


Each 2-mL dose is ready to use and is given orally. It should be refrigerated. Rotavirus vaccine can be administered with other childhood vaccines at two, four, and six months of age or at four-to 10-week intervals beginning at six to 12 weeks of age, with completion of the three-dose series by 32 weeks; vaccination outside of this age group is not recommended.14

Bottom Line

Although costly, rotavirus pentavalent vaccine has been shown to be safe, with no increased risk of intussusception. It also has shown to reduce the need for hospitalization and emergency department visits connected with rotavirus gastroenteritis, decrease office visits associated with rotavirus, and reduce lost work days for parents or guardians. Rotavirus pentavalent vaccine can be administered with other vaccinations at two, four, and six months of age. Because it is given orally, it does not add to the number of injections given to infants.


show all references

1. RotaTeq (rotavirus pentavalent vaccine) [Product information]. Whitehouse Station, N.J.: Merck & Co., Inc., 2006. Accessed July 21, 2006, at:

2. Prevention of rotavirus gastroenteritis among infants and children: provisional ACIP recommendations for the use of rotavirus vaccine (RV). Accessed July 21, 2006, at:

3. U.S. Food and Drug Administration. RotaTeq questions and answers. Accessed July 21, 2006, at:

4. Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, et al., for the Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006;354:23–33.

5. Aetna clinical policy bulletin, no. 0723. Rotavirus vaccine. Accessed July 21, 2006, at:

STEPS drug updates cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each update provides an independent review of a new medication by authors who have no financial association with the drug manufacturer.

The series coordinator is Allen F. Shaughnessy, Pharm.D., Tufts University Family Medicine Residency Program, Malden, Mass.



Copyright © 2006 by the American Academy of Family Physicians.
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