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What is Rotavirus Vaccine?


rotavirus

There are two FDA approved rotavirus vaccines available for use in the United States. These vaccines differ in how they are made and in the number of doses prescribed when they are given. Both are given orally and contain genetically engineered live attenuated human rotavirus strains or hybrid human-bovine (cow) reassortment rotavirus strains.

About RotaTeq® Vaccine in Brief

  • Ages:  RotaTeq live oral vaccine is approved for use in infants between the ages of six and 32 weeks (see Merck product insert for recommended schedule and other indications.)
  • Description: RotaTeq is a genetically engineered vaccine made of live, attenuated human-bovine hybridized reassortant (mix of genetic material from different species) rotaviruses. Other ingredients include sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. It does not contain preservatives.
  • Estimated Efficacy: RotaTeq will not prevent diarrhea or vomiting caused by viruses other than rotavirus. Studies indicate RotaTeq will prevent about 74 percent of rotavirus cases, about 98 percent of severe cases, and about 96 percent of hospitalizations due to rotavirus.
  • Use with other vaccines: In pre-licensing clinical trials, RotaTeq was given simultaneously with DTaP, IPV (polio), hepatitis B, Haemophilus Influenzae Type B (HIB), and pneumococcal conjugate vaccines; however, no information is available on administering RotaTeq with influenza vaccine.
  • Commonly Reported Adverse Events: Vomiting, diarrhea, irritability, fever, otitis media, nasopharyngitis, and bronchospasm.
  • Serious Reported Adverse Events: Intussusception, bronchiolitis, pneumonia, fever, gastroenteritis, urinary tract infection, hematochezia (fresh blood in the stool), seizures, Kawasaki disease, anaphylactic reaction, urticaria, angioedema, and death
  • Contraindications to RotaTeq vaccination:
    • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
    • Severe Combined Immunodeficiency Disease (SCID)
    • A history of intussusception
  • Precautions to RotaTeq vaccination:
    • Infants born to HIV infected mothers unless it has been determined that the infant does not have HIV infection
    • Infants with weakened immune systems
    • Fever greater than 100.5F (38.1C)
    • Current gastrointestinal illness
    • History of rotavirus infection
    • History of gastrointestinal illness and frequent diarrhea
    • Failure to thrive
    • History of stomach problems since birth
    • History of abdominal surgery
    • Receipt of blood or blood products within 42 days
    • Living in a home with individuals who are immunocompromised

RotaTeq 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 May 7, 2010, the FDA announced that RotaTeq vaccine was contaminated with DNA from two porcine circoviruses: PCV1 and PCV2.  Although PCV1 has not been associated with clinical disease in pigs, PCV2 is a lethal pig virus that causes immune suppression and a serious wasting disease in baby pigs that damages lungs, kidneys, the reproductive system, brain and ultimately causes death.  The FDA recommended temporary suspension of the use of ROTARIX vaccine on March 22, 2010 after DNA from PCV1 was identified in ROTARIX but did not call for suspension of the use of RotaTeq vaccine after PCV2 was found in RotaTeq.1  To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines.2

About ROTARIX® Vaccine in Brief

  • 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). 3
  • 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.4 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.5 PCV1 remains a contaminant  of the ROTARIX vaccine.6

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.

« Return to Vaccines & Diseases Table of Contents

References

1 Schnirring L. Second rotavirus vaccine found to contain porcine circovirus. CIDRAP News. May 7, 2010.

2 Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Appendix B: Vaccine Excipient Summary - Excipients included in U.S. Vaccines, by Vaccine In: Epidemiology and Prevention of Vaccine-Preventable Diseases. February 2020.

3 Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med Jan. 2006;354(1):11-22.

4 Schrinning L. FDA urges clinicians to suspend use of GSK rotavirus vaccine CIDRAP News Mar. 22, 2010.

5 U.S. Food and Drug Administration. Information for Parents and Caregivers. In: Vaccines, Blood, and Biologics. May 14, 2010.

6 Communication and Education Branch, National Center for Immunization and Respiratory Diseases (NCIRD) and the Centers for Disease Control (CDC). Appendix B: Vaccine Excipient Summary - Excipients included in U.S. Vaccines, by Vaccine In: Epidemiology and Prevention of Vaccine-Preventable Diseases. February 2020.


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