Rotavirus Vaccines

//Rotavirus Vaccines

Rotavirus Vaccine Suspended

The Centers for Disease Control (CDC) and the American Academy of Pediatrics (AAP) announced on 7/15/99 that all rotavirus vaccination is being suspended because of reports of bowel obstruction developing within weeks of vaccination.

Intussuseption Cases

Rotavirus vaccine was licensed on August 31, 1998, and subsequently recommended for routine use for all U.S. infants. From October 1998 to December 1999, 112 cases of intussusception were reported to the passive surveillance system (VAERS) — known for it’s underreporting problems.(1) At least a fourfold increase over the expected number of intussusception cases occurring within 1 week of receipt of rotavirus vaccine. In light of these and other data, the rotavirus vaccine manufacturer voluntarily removed its product from the market, and the recommendation for routine use of rotavirus vaccine among US infants has been withdrawn.(2)

Other Adverse Reactions

Rotavirus shedding was detected in 125 (50.4%) subjects(3). Irritability, decreased appetite and abdominal cramping on Days 3 to 5 postvaccination were also more common in the RRV-TV vaccine recipients than in the placebo recipients. One child was hospitalized and 2 more infants seen in the clinic, vs. none in the placebo group. “Conclusions: The first dose of RRV-TV vaccine is associated with a relatively high rate of febrile and other reactions, which may require a physician visit and, rarely, hospitalization.” (4)


Highly Treatable

Infant diarrhea caused by rotavirus is highly treatable with rehydration therapy and, unlike in poor Third World countries, rotavirus does not cause widespread death among children in the US. Vaccination is unnecessary.


Rotavirus Vaccines by Brand

Rotarix® Rotavirus vaccine, live
Manufacturer GSK Biologicals, Belgium
Microorganism Rotavirus
Licensed 02/21/2006
Recommendations Two doses, four weeks apart, first dose may be given from the age of 6 weeks.
Ingredients Sorbitol, Sucrose, Virus: Rotavirus (live, attenuated), Dextran, Amino acids, Dulbecco’s Modified Eagle Medium, Calcium carbonate, Xanthan gum
Product Descriptions

Rotashield Rotavirus Vaccine, Live, Oral, Tetravalent
Manufacturer Wyeth-Aherst
Microorganism Rotavirus gastroenteritis
Licensed withdrawn from the market in 1999
Recommendations 2, 4, 6 months, may be administered as early as six weeks with subsequent doses 3 weeks apart, initiation of vaccination after 6 months not recommended.
Ingredients Amphotericin B, Monosodium Glutamate (MSG), Sucrose, Bovine (cow) serum, Potassium phosphate, Virus: Rotavirus (live, attenuated), Minimum Essential Medium, Potassium monophosphate
Product Descriptions

RotaTeq For Prevention of Rotavirus Gastroenteritis
Manufacturer Merck
Microorganism Rotavirus Gastroenteritis
Licensed 02/12/2007
Recommendations 3 injections for full term infants beginning at 6-12 weeks of age.
Ingredients Polysorbate 80, Sucrose, Sodium phosphate-monobasic, Bovine (cow) serum, Sodium hydroxide, Virus: Rotavirus (live, attenuated), Sodium citrate
Product Descriptions Corporate