- Ages: ROTARIX live oral vaccine is approved for use in infants between the ages of six and 24 weeks (see GlaxoSmithKline product insert for recommended schedule and other indications.)
- Description: ROTARIX is a genetically engineered vaccine made of live attenuated human rotaviruses. Other ingredients include: amino acids, dextran, sorbitol, sucrose, and Dulbecco’s Modified Eagle Medium (DMEM). DMEM contains sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the stomach and prevents its inactivation due to the acidic environment of the stomach.
- Estimated Efficacy: According to a study published in the New England Journal of Medicine, the efficacy of ROTARIX against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001).
- Use with other vaccines: In pre-licensing clinical trials, ROTARIX was given simultaneously with PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Haemophilus Influenzae Type B (HIB), and pneumococcal conjugate vaccines; however, no information is available on administering ROTARIX with influenza vaccine.
- Commonly Reported Adverse Events: Diarrhea, fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
- Serious Reported Adverse Events: Intussusception, Kawasaki Disease, hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID), idiopathic thrombocytopenic purpura, convulsions, pneumonia and death.
- Contraindications to ROTARIX vaccination:
- Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
- Severe Combined Immunodeficiency Disease (SCID)
- A history of intussusception
- A history of uncorrected congenital malformation of the gastrointestinal tract that would make an infant susceptible to intussusception
- Precautions to ROTARIX vaccination:
- Current gastrointestinal illness
- History of rotavirus infection
- History of gastrointestinal illness and frequent diarrhea
- Latex sensitivity – the tip caps of the prefilled oral applicators of the diluent contain natural rubber latex
- Infants with weakened immune systems
- Living in a home with individuals who are immunocompromised
ROTARIX is a live virus vaccine and transmission of vaccine virus has been reported from vaccine recipients to non-vaccinated contacts. This vaccine has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
On March 22, 2010, the FDA announced that an independent U.S. academic research team had found DNA from porcine circovirus 1 (PCV1) in the ROTARIX vaccine. The FDA recommended that healthcare practitioners temporarily suspend use of ROTARIX vaccine in the U.S. while the agency learned more about PCV1; however, they reported that this finding posed no safety concerns and stated that PCV1 was not known to cause illness in humans or other animals. On May 14, 2010, the FDA announced that they had reviewed the scientific evidence and determined that the vaccine was safe and use of the product should continue. PCV1 remains a contaminant of the ROTARIX vaccine.
IMPORTANT NOTE: NVIC encourages you to become fully informed about rotavirus and rotavirus vaccines by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
