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Rotavirus is a virus that causes severe diarrhea, mainly in infants and young children. In fact, 95% of all children have had rotavirus illness by 5 years of age. Rotavirus spreads from person to person by the fecal-oral route. People become infected by eating or drinking something that has been contaminated with feces from an infected person. The virus also can be found in water sources, such as private wells, that have been contaminated with feces from infected persons.

Rotavirus can be found in the stool of an infected person about 1 day after exposure until about 10 days after symptoms begin. Symptoms usually begin about two days after exposure and last from three to seven days. Symptoms typically begin with fever and upset stomach followed by diarrhea.

Because large amounts of fluids are lost in diarrhea and fluid intake is often poor, dehydration is a major complication of rotavirus infections. There is no specific treatment for rotavirus infections; instead, treatment focuses on fluid replacement and supportive care. If the person cannot drink enough, intravenous fluids may be needed.      

About the Vaccine

There are currently two rotavirus vaccines available for use in the United States. Both are live attenuated oral vaccines.

Rotavirus Vaccines Licensed for Use in the U.S.

Product: Rotarix® (Rotavirus)
Manufacturer: GlaxoSmithKline
Year licensed: 2008
Product Insert

Product: RotaTeq® (Rotavirus)
Manufacturer: Merck & Co.
Year licensed: 2006
Product Insert

Indications Contraindications and precautions
  • Infants 6 through 32 weeks of age. Note: Must begin vaccine series before 15 weeks of age.
  • Infants who have had a severe allergic reaction to a previous dose of rotavirus vaccine or a rotavirus vaccine component.*
  • Infants who are moderately or severely ill should wait until recovery before receiving any vaccine. Minor illnesses, such as a cold, are not a contraindication.
  • Infants who are or have a history of immune compromised due to disease, treatment, or medication.
  • Infants who have a history of intussusception.
  • Infants younger than 6 weeks of age or older than 8 months of age.
  • Caution is advised when administering vaccine to infants with a history of gastrointestinal disorders or acute gastrointestinal illness.
  • History of uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusceptions.
  • Vaccine virus transmission from vaccine recipient to non-vaccinated contacts has been reported. Caution is advised when considering whether to administer RotaTeq to individuals with immunodeficient contacts.
  • Spina bifida or bladder exstrophy are precautions to rotavirus vaccine.

* Rotarix® oral applicator contains latex.

Vaccine Dose/Route Routine Administration Schedule
Rotarix Dose: 1 ml

Route: Oral
2 doses at 2 and 4 months of age.*
RotaTeq Dose: 2 ml

Route: Oral
3 doses at 2, 4, and 6 months of age.*

* First dose can be given as early as 6 weeks of age and should be given by 14 weeks and 6 days. Vaccination should not be initiated for infants 15 weeks and 0 days of age or older because of insufficient data on safety when first dose is given to older infants. The maximum age for the last dose of rotavirus vaccine is 8 months and 0 days.

Rotavirus Side Effects
  • Slightly increased rate of irritability
  • Mild diarrhea or vomiting.
  • Severe allergic reaction (very rare).
  • Intussusception (1 case per 100,000 infants):
    • Stomach pain
    • Severe crying
    • Bloody stools
    • Weakness
Product Name Supplied Storage and Handling
1 mL single dose vial with diluent (10 sets per package). Store refrigerated between 2° to 8°C (35° to 46°F). No not freeze. Diluent can be stored in the refrigerator or at room temperature.

Reconstituted vaccine needs to be administered within 24 hours or discarded.
Merck & Co
1 mL single dose tubes (10 or 25 per package). Store refrigerated between 2° to 8°C (35° to 46°F). Do not freeze. Protect from light.

RotaTeq is a pale yellow clear liquid that may have a pink tint.     
rotavirus vaccine, live, oral, pentavalent
Rotavirus PDF 02 Dec 15
Information Paper
Package Insert - Vaccine
RotaTeq (Merck) 01 Sep 11
Package Insert - Vaccine
Vaccine Information Statement (Interim)