- 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. To date, PCV1 and PCV2 continue to contaminate RotaTeq vaccines.
