Rotavirus Vaccine

Two rotavirus vaccines (Rotateq® and Rotarix®) are recommended for babies to reduce the risk of gastroenteritis. One of the most severe vaccine side effects is intussusception, a life-threatening intestinal blockage.

What is the rotavirus vaccine?

Two different rotavirus vaccines are both recommended for infants to prevent gastroenteritis, an intestinal infection caused by rotavirus. The disease spreads easily among children in daycare and school. Around 40-70% of infants who get the vaccine will be protected from infection.

What are rotavirus vaccine names?

There are two rotavirus vaccines licensed for use in the United States:

  • RotaTeq® (RV5) — Contains 5 reassortant rotaviruses. It is given orally in 3 doses at ages 2 months, 4 months, and 6 months. It was approved in 2006 and is manufactured by Merck & Co.
  • Rotarix® (RV1) — Contains 1 attenuated (weakened) human rotavirus strain. It is given orally in 2 doses at ages 2 months and 4 months. It was approved in 2008 and is manufactured by GlaxoSmithKline.

These vaccines were developed to replace RotaShield®, the first vaccine against rotavirus. RotaShield was withdrawn in 1999 because it was associated with an increased risk of intussusception.

Who gets the rotavirus vaccine?

The first dose of the rotavirus vaccine is most effective if it is given before a child is 15 weeks old. Infants should receive their final dose of the rotavirus vaccine before they are 8 months old. The minimum interval between each dose is 4 weeks. Rotavirus vaccines are given orally by putting drops in the mouth, instead of a shot or injection.

What is the immunization schedule for rotavirus?

RotaTeq (RV5) is given orally in 3 doses, with one dose given at each of the following ages: 2 months, 4 months, and 6 months.

Rotarix (RV1) is given orally in 2 doses, with one dose given at each of the following ages: 2 months and 4 months.

Both vaccines are recommended for infants. The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends both RV1 and RV5 in the routine childhood immunization schedule.

What are common side effects of rotavirus vaccines?

  • Airway tightening (bronchospasm)
  • Cough
  • Diarrhea
  • Ear infection (otitis media)
  • Fever
  • Irritability
  • Loss of appetite
  • Runny nose (nasopharyngitis)
  • Vomiting

Do rotavirus vaccines cause intussusception?

Yes. Intussusception is a rare but potentially deadly side effect of rotavirus vaccines. Intussusception is a severely painful type of bowel obstruction that occurs when the intestines fold in on themselves like a telescope.

The first dose of the rotavirus vaccine is associated with 1 to 1.5 cases of Intussusception per 100,000 doses. Rotavirus vaccines should NOT be given to infants with a history of intussusception or a rare disorder called Severe Combined Immunodeficiency (SCID).

Overall, the estimated risk of intussusception from rotavirus vaccines ranges from 1 in 20,000 infants to 1 in 100,000 infants, usually within 7 to 21 days of the baby’s 1st or 2nd dose of the rotavirus vaccine.

What are severe side effects of rotavirus vaccines?

Vaccinated children can spread rotavirus infections to caregivers and other children. The virus in the vaccine is shed in the infant’s stools in the first weeks after administration of the vaccine. Therefore, caregivers must be very careful to wash their hands after diaper changes.

Rotavirus vaccines may also cause anaphylaxis, a life-threatening allergic reaction. These reactions are very rare, estimated to occur after fewer than 1 in a million doses, and usually within a few hours.

There have also been reports of other severe rotavirus vaccine side effects, such as:

  • Anaphylactic reaction
  • Angioedema
  • Death
  • Fever causing seizure (febrile convulsion)
  • Gastroenteritis with vaccine viral shedding
  • Hematochezia
  • Idiopathic thrombocytopenic purpura
  • Intussusception resulting in death
  • Kawasaki disease
  • Rotavirus infections
  • Seizures
  • Transmission of vaccine rotavirus strains from vaccine recipient to non-vaccinated contacts

Where can I get more information?

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