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Who Should Not Get Rotavirus Vaccine?


contraindication

Contraindications to receiving the RotaTeq vaccine documented in Merck’s package insert include:1

  • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
  • A diagnosis of Severe Combined Immunodeficiency Disease (SCID)
  • A history of intussusception

Infants with the following medical conditions may be at a greater risk of harm from RotaTeq vaccination:2

  • 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

Infants living with immunocompromised individuals might put others at risk of rotavirus infection through vaccine strain shedding and transmission from RotaTeq vaccines.

RotaTeq is FDA approved for use in infants between six and 32 weeks of age. Infants under six weeks or older than 32 weeks should not receive RotaTeq.3

Contraindications to receiving the ROTARIX vaccine documented in GlaxoSmithKline’s package insert include:4

  • Hypersensitivity to any ingredient found within the vaccine or to a previous vaccine dose
  • A diagnosis of 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

Infants with the following medical conditions may be at a greater risk of harm from ROTARIX vaccination:5

  • 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 a latex sensitivity or allergy may be at risk of harm if exposed to the oral applicators
  • Infants with weakened immune systems

Infants living with immunocompromised individuals might put others at risk of rotavirus infection through vaccine strain shedding and transmission from ROTARIX vaccines.

ROTARIX is FDA approved for use in infants between six and 24 weeks of age. Infants under six weeks or older than 24 weeks should not receive ROTARIX.6

The first dose of rotavirus vaccine should not be administered to an infant after 14 weeks and 6 days of age and no vaccine doses should be administered after eight months of age.7

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

1Merck Sharp & Dohme Corp. RotaTeq – Label. U.S. Food and Drug Administration.  Aug. 17, 2020.

2 U.S. Food and Drug Administration. RotaTeq (Rotavirus Vaccine) Questions and Answers. In: Vaccines, Blood, and Biologics. Mar. 26, 2018.

3 Merck Sharp & Dohme Corp. RotaTeq – Label. U.S. Food and Drug Administration. Aug. 17, 2020.

4 GlaxoSmithKline Biologicals. Package Insert and Patient Information – Rotarix. U.S. Food and Drug Administration. Dec. 12, 2019.

5 GlaxoSmithKline Biologicals. Package Insert and Patient Information – Rotarix. U.S. Food and Drug Administration. Dec. 12, 2019.

6 GlaxoSmithKline Biologicals. Package Insert and Patient Information – Rotarix. U.S. Food and Drug Administration. Dec. 12, 2019.

7 Cortese MM, Parashar UD. Prevention of Rotavirus Gastroenteritis Among Infants and Children Recommendations of the Advisory Committee on Immunization Practices (ACIP) MMWR Feb. 6, 2009; 58(RR02):1-25.


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