Merck & Co's RotaTeq (rotavirus vaccine, live, oral, pentavalent)

JULY 01, 2006
rx PRODUCTnews PROFILE: Merck & Co's RotaTeq (rotavirus vaccine, live, oral, pentavalent)

The FDA has approved Merck & Co's RotaTeq (rotavirus vaccine, live, oral, pentavalent). RotaTeq is indicated for infants and children for the prevention of rotavirus gastroenteritis from the G1, G2, G3, and G4 rotavirus serotypes.1

RotaTeq is an orally administered vaccine given as a series of 3 subsequent doses. The initial dose should be given at 6 to 12 weeks of age, with the following doses given at 4-to 10-week intervals. The final dose should be given before 32 weeks of age.1 To enhance patient convenience and compliance, many providers recommend administering the vaccine at the 2-, 4-, and 6-month wellbaby visits.2 RotaTeq is available as a ready-to-administer oral solution in a latex-free dosing tube.1

The exact mechanism of RotaTeq is unknown. The live oral vaccine has been shown, however, to replicate in the small intestine, thus creating immunity in the patient.

About Rotavirus

Initially discovered in 1973, rotavirus gastroenteritis is a leading cause of severe diarrhea, vomiting, fever, and dehydration in infants and young children.3,4 It is most common in children between ages 6 and 24 months. An estimated 95% of all infants and children are infected by 5 years of age.1,2 Symptoms of rotavirus infection after age 5 are rare, probably as a result of prior infections with rotavirus, which eventually lead to resistance.

In temperate climates, cases of rotavirus gastroenteritis tend to be more common in the colder seasons. In tropical regions, however, rotavirus gastroenteritis has been noted to occur year-round.3

Various strains of rotavirus exist, and classification of the viruses is based on their 2 outer capsid proteins: VP7, which is also referred to as G protein, and VP4, also referred to as P protein. Although strain types vary by year and location, the most common strains include G1, G2, G3, G4, and G9.3

In the United States each year, rotavirus infection is responsible for >400,000 doctor visits, 200,000 emergency department visits, 55,000 to 70,000 hospitalizations, and 20 to 60 deaths of children under age 5.4Worldwide, ~400,000 children die from rotavirus each year, accounting for about 5% of all childhood deaths.3

Due to the severe complications of rotavirus gastroenteritis, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices has recommended that RotaTeq become included in the CDC's Vaccines for Children (VFC) program. The VFC program provides vaccines to un-or underinsured children.2

Clinical Trials

RotaTeq was evaluated in 72,324 infants in 3 placebo-controlled, phase 3 clinical studies. The vaccine was administered to healthy infants, with the first dose given between age 6 and 12 weeks and the following 2 doses at 4-to 10-week intervals. The final dose was administered before age 32 weeks. End points evaluated in the trial were the incidence of any severity of rotavirus gastroenteritis, the incidence of severe rotavirus gastroenteritis, and rotavirus-related hospitalization rates. RotaTeq was found to prevent ~74% of all rotavirus gastroenteritis cases and ~98% of severe cases. Additionally, 95% of rotavirus-related hospitalizations were prevented in the RotaTeq group.1,4


Diarrhea, vomiting, fever, runny nose, sore throat, wheezing, coughing, and ear infection were the most common side effects after vaccination with RotaTeq. RotaTeq should not be given to immunocompromised infants or to infants with a known hypersensitivity to the product. Unless the benefit outweighs the risk, infants with a fever >100.5º F (38.1º C) should not receive RotaTeq.

Patient Education

Protection against rotavirus gastroenteritis after 1 or 2 doses has not been determined. Unless circumstances prevent it, parents should be encouraged to complete the RotaTeq series. As with all vaccines, vaccination with RotaTeq does not guarantee complete protection from rotavirus gastroenteritis, nor does it protect against gastroenteritis caused by viruses other than rotavirus.1

Dr. Holmberg is a pharmacist with Phoenix Children's Hospital, Phoenix, Ariz.

For a list of references, send a stamped, self-addressed envelope to: References Department, Attn. A. Stahl, Pharmacy Times, 241 Forsgate Drive, Jamesburg, NJ 08831; or send an e-mail request to: