Rotavirus Vaccine

Before your baby is given rotavirus vaccine, make sure your doctor knows:

• If your baby has been unwell recently or has a high temperature (fever).
• If your baby has been sick (vomited) or has had loose, watery stools (diarrhoea) recently.
• If your baby has previously had an allergic reaction to a vaccine or medicine.
• If your baby has had a blockage in their bowel, called intussusception.
• If you have been told your baby has a weakened immune system or is being treated with a medicine that can weaken the immune system.
• If whilst pregnant with your baby or whilst breast-feeding you have been given a treatment, called a TNF-alpha inhibitor, that weakens the immune system.

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with rotavirus vaccine. You will find a full list in the manufacturer's information leaflet. Ask the person giving the vaccine for a copy of the leaflet and speak with your doctor or pharmacist if any side-effects become troublesome.

As with all vaccines, there is a very small risk of an allergic reaction. Contact your doctor straightaway if you have any concerns, or if your child experiences any other symptoms which you think may be due to this vaccine.

• Human Rotavirus Vaccine, Attenuated (HRV)
• Pentavalent Human-Bovine Reassortant Rotavirus Vaccine (PRV)
• Rotavirus Vaccine, Pentavalent
• RV1 (Rotarix)
• RV5 (RotaTeq)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Powder, for suspension, oral [preservative free; human derived]:

Rotarix: G1P[8] ≥106 CCID50 per 1 mL [contains sorbitol, sucrose; supplied with diluent which may contain natural rubber/natural latex in packaging]

Solution, oral [preservative free; bovine and human derived]:

RotaTeq: G1 ≥2.2 x 106 infectious units, G2 ≥2.8 x 106 infectious units, G3 ≥2.2 x 106 infectious units, G4 ≥2 x 106 infectious units, and P1A [8] ≥2.3 x 106 infectious units per 2 mL (2 mL) [contains sucrose]

• Rotarix
• RotaTeq

Following administration of rotavirus vaccine, efficacy of protecting against any grade of rotavirus gastroenteritis through two seasons was 71% to 79%.

Prevention of rotavirus gastroenteritis: Oral:

Manufacturer's labeling:

Infants 6 to 24 weeks of age: Rotarix: A total of two 1 mL doses (U.S. labeling) or two 1.5 mL doses (Canadian labeling), the first dose given at 6 weeks of age, followed by the second dose given ≥4 weeks later. The 2-dose series should be completed by 24 weeks of age.

Infants 6 to 32 weeks of age: RotaTeq: A total of three 2 mL doses, the first dose given at 6 to 12 weeks of age, followed by subsequent doses at 4- to 10-week intervals. Administer all doses by 32 weeks of age.

ACIP recommendations (CDC/ACIP [Cortese, 2009]): The first dose can be given at 6 to 14 weeks of age. The series should not be started in infants ≥15 weeks. The final dose in the series should be administered by 8 months 0 days of age. The minimum interval between doses is 4 weeks. RotaTeq should be given in 3 doses administered at 2-, 4-, and 6 months of age. Rotarix should be given in 2 doses administered at 2- and 4 months of age. For infants inadvertently administered rotavirus vaccine at ≥15 weeks of age, the vaccine series may be completed according to schedule. The ACIP recommends to complete the vaccine series with the same product whenever possible. If continuing with same product will cause vaccination to be deferred, or if product used previously is unknown, vaccination should be completed with the product available. If RotaTeq was used in any previous doses, or if the specific product used was unknown, a total of 3 doses should be given. Infants who have had rotavirus gastroenteritis before getting the full course of vaccine should still initiate or complete the recommended schedule; initial infection provides only partial immunity.

Rotarix: Reconstitute only with provided diluent and transfer adapter. After removing the vial cap, connect transfer adapter onto vial and push downwards until transfer adapter is in place. Shake oral applicator containing the liquid diluent (suspension will be a turbid liquid). Connect oral applicator to transfer adapter and transfer entire contents (diluent) of oral applicator into the lyophilized vaccine. With transfer adapter in place, shake vigorously. Withdraw entire mixture back into oral applicator. Twist and remove oral applicator.

RotaTeq: Clear the fluid from the dispensing tip by holding the tube vertically and tapping the cap. Puncture the dispensing tip by screwing the cap clockwise until it becomes tight and then remove the cap by turning it counterclockwise.

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine administration (NCIRD/ACIP, 2011).

• Intussusception: An increased risk of intussusception was observed with a previously licensed rotavirus vaccine. Cases have been noted in postmarketing reports and a temporal association has been observed in postmarketing observational studies with current vaccines. Cases were noted within 21 to 31 days of the first dose, with a clustering of cases within the first 7 days following administration. An increased risk was also observed within the first 7 days of the second dose. Use of RotaTeq and Rotarix is contraindicated with a history of intussusception. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose.

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Consider deferring administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (NCIRD/ACIP, 2011).

• Gastrointestinal disease: Use with caution in infants with history of GI disorders, acute mild GI illness, chronic diarrhea, failure to thrive, congenital abdominal disorders, and abdominal surgery; vaccine may be used with controlled gastroesophageal reflux disease. ACIP recommends that the vaccine should generally not be administered to infants with acute moderate or severe gastroenteritis. (CDC/ACIP [Cortese, 2009]). Rotarix is contraindicated with a history of an uncorrected congenital malformation of the GI tract; RotaTeq and Rotarix are contraindicated with a history of intussusception.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist (NCIRD/ACIP, 2011).

Special populations:

• Adults: Not intended for use in adults.

• Immunocompromised family members: Virus from live virus vaccines may be transmitted to nonvaccinated contacts; use with caution in the presence of immunocompromised family members. Viral shedding occurs within the first weeks of administration; peak viral shedding generally occurs ~7 days after the first dose. The ACIP recommends vaccination of infants living in households with persons who are immunocompromised (CDC/ACIP [Cortese, 2009]).

• Immunocompromised infants: Safety and efficacy have not been established for use in immunocompromised infants (including blood dyscrasias, leukemia, lymphoma, malignant neoplasms affecting bone marrow or lymphatic system), infants on immunosuppressants (including high-dose corticosteroids; may be administered with topical corticosteroids or inhaled steroids), or infants with primary and acquired immunodeficiencies (including HIV/AIDS, cellular immune deficiencies, hypogammaglobulinemic and dysgammaglobulinemic states). The ACIP recommendations support vaccination of HIV-exposed or infected infants, since the diagnosis of infection may not be made prior to the first dose of the vaccine and also because strains of rotavirus vaccine are considerably attenuated (CDC/ACIP [Cortese, 2009]). In general, live vaccines should be administered ≥4 weeks prior to planned immunosuppression and avoided within 2 weeks of immunosuppression when feasible. Specific recommendations for use of this vaccine in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin, 2014).

Dosage form specific issues:

• Latex: Some packaging may contain natural latex/natural rubber

Other warnings/precautions:

• Antipyretics: Antipyretics have not been shown to prevent febrile seizures; antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).

• Appropriate use: Administration errors have been reported. This vaccine is for oral administration only; doses inadvertently administered by injection are not considered valid and an oral replacement dose should be given according to the appropriate age and schedule (CDC [Hibbs, 2014]).

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (NCIRD/ACIP, 2011).

• Postexposure prophylaxis: Information is not available for use in postexposure prophylaxis.

• Discuss specific use of vaccine and side effects with caregiver as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience irritability, rhinorrhea, lack of appetite, abnormal crying, or pharyngitis. Have caregiver report immediately to prescriber ear pain, wheezing, cough, blood in stool, severe diarrhea, vomiting, abdominal pain, or signs of Kawasaki disease (high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs) (HCAHPS).

• Educate caregiver about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Caregiver should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.