Rotavirus vaccine (Rotarix) is used to prevent severe diarrhea in children caused by Rotavirus infection. Rotavirus infection is the most common cause of diarrhea in children in developed and developing countries.

Rotavirus vaccine (Rotarix) Uses:

• Rotavirus gastroenteritis prevention:
  • Rotarix: To prevent gastroenteritis caused by rotavirus in infants 6 to 24 weeks of age caused by the serotypes G1, G3, G4, and G9 when administered as a 2-dose series.
  • RotaTeq: To prevent gastroenteritis caused by rotavirus in infants 6 to 32 weeks of age caused by the serotypes G1, G2, G3, G4, and G9 when administered as a 3-dose series.
• The Advisory Committee on Immunization Practices (ACIP) has recommended routine vaccination of all infants (CDC/ACIP [Cortese 2009]).

Rotavirus vaccine (Rotarix) Dose in Adults

Not indicated.

Rotavirus vaccine (Rotarix) Dose in Children

Note:

• CDC/ACIP annual immunization schedules or National Advisory Committee on Immunization (NACI) guidelines (Canada) should be consulted regarding additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions.
• According to ACIP, doses are considered valid when administered ≤4 days before minimum interval or age; however, local or state mandates may supersede this timeframe.

Rotavirus vaccine (Rotarix) Dose as Primary immunization:

The ACIP has recommended that the vaccine series should be completed with the same product whenever possible. Use the available product to complete vaccination if continuing with the same product will cause vaccination to be deferred, or if the product used previously is unknown. Give a total of 3 doses, if RotaTeq was used in any previous doses, or if the specific product used was unknown.

Rotarix:

• Infants 6 to 24 weeks of age:
  • Oral: 1 mL per dose should be given for 2 doses, give the first dose given at 6 weeks of age, and the second dose should be given at ≥4 weeks later. Complete the 2-dose series by 24 weeks of age.

RotaTeq:

• Infants 6 to 32 weeks of age:
  • Oral: 2 mL per dose should be given for 3 doses, give the first dose at 6 to 12 weeks of age, and the subsequent doses should be given at 4- to 10-week intervals. All doses should be administered by 32 weeks of age.
• ACIP recommendations:
  • Give the first dose at 6 weeks through 14 weeks at 6 days of age.
  • Do not start the series in infants ≥15 weeks.
  • Give the final dose in the series by 8 months 0 days of age.
  • 4 weeks minimum interval should be there between doses. Give Rotarix in 2 doses administered at 2and 4 months of age.
  • Give RotaTeq in 3 doses administered at 2-, 4-, and 6 months of age.
  • The vaccine series may be completed according to schedule in infants who are inadvertently administered the rotavirus vaccine at ≥15 weeks of age.
  • The vaccine should still be initiated or completed as per the recommended schedule in infants who have had rotavirus gastroenteritis before getting the full course because only partial immunity is provided by the initial infection.

Canadian labeling:

• Rotarix:
  • Infants 6 to 24 weeks of age:
    • Oral: A total of 2 doses of 1.5 mL each, give the first dose at 6 weeks of age, and the second dose should be given ≥4 weeks later.
    • Complete the 2-dose series by 24 weeks of age.

Rotavirus vaccine (Rotarix) Dose in the Catch-up immunization:

• ACIP Recommendations:
  • Oral: Note:
    • The series should not be restarted. Begin the catch-up schedule at the applicable dose number if doses have been given and separate doses by 4 weeks; a total of three doses. Do not start the series in infants ≥15 weeks and 0 days. Give the final dose in the series by 8 months 0 days of age. The vaccine series should be completed according to schedule and prior to 8 months and 0 days of age in infants who were inadvertently administered the rotavirus vaccine at ≥15 weeks of age. Give a total of 3 doses if RotaTeq was used in any previous doses, or if the specific product used was not known.

Pregnancy Risk Factor C

• There have not been any reproduction studies.
• Avoid use for women who are pregnant. You may vaccinate infants who live in households with mothers.

Rotavirus vaccine use during breastfeeding:

• Breastfeeding is permitted for infants who have received the vaccine.

Dose in Kidney Disease:

No dosage adjustments have been provided in the manufacturer's labeling.

Dose in Liver disease:

No dosage adjustment is recommended.

Ranges reported; actual percentage may vary between products.

Common Side Effects of Rotavirus vaccine (Rotarix):

• Central Nervous System:
  • Irritability
• Gastrointestinal:
  • Diarrhea
  • Vomiting
• Otic:
  • Otitis Media
• Miscellaneous:
  • Fussiness

Less Common Side Effects of Rotavirus vaccine (Rotarix):

• Gastrointestinal:
  • Flatulence
• Respiratory:
  • Nasopharyngitis
  • Bronchospasm

Contraindications to Rotavirus vaccine (Rotarix):

• Hypersensitivity to rotavirus vaccine and any component of the formulation
• History of uncorrected congenital malformations of the GI tract that predisposes an infant to intussusception (Rotarix only).
• History of intussusception
• SCID (severe combined immunedeficiency disorder)

Warnings and precautions

• Anaphylactoid reactions and hypersensitivity reactions
  • Arrange immediate treatment, including epinephrine (1 mg/mL), for any anaphylactoid or hypersensitivity reactions after administering the vaccine.
• Intussusception
  • Intussusception was a greater risk for those who had previously been licensed to use rotavirus vaccine.
  • Postmarketing reports have confirmed the cases, and observational studies postmarketing have demonstrated a temporal association between current vaccines.
  • After 21 to 31 days after the administration of the first dose, patients were observed. Clustering was seen within 7 days.
  • The 2nd dose also had an increase in risk within the first seven days.
  • After a history of intussusception following the first dose, postmarketing experience has shown that there have been cases of death from intussusception.
• Acute illness:
  • The severity of the febrile illness and its etiology will determine whether a decision should be made about giving or delaying vaccinations.
  • Patients with severe or moderate acute illness should not be vaccinated (with or with out fever), but patients with mild acute illnesses (with or with fever) should not be vaccinated.
• GI disease:
  • Avoid use in infants who have had GI problems, acute mild GI illnesses, chronic diarrhea, failure of growth, congenital abdominal conditions, or abdominal surgery.
  • You may use vaccines with controlled GERD.
  • ACIP recommends that infants suffering from acute, moderate, or severe gastroenteritis should not be given the vaccine.

Rotavirus vaccine (RV1 and RV5): Drug Interaction

Monitoring Parameters:

None mentioned.

How to administer the Rotavirus vaccine (Rotarix)?

Oral use only; not for injection.

May be given before or after food, milk, or breast milk. Should be administered gently inside the cheek to avoid potential eye splashes caused by coughing, sneezing, and spitting. As per US law, the following details should be entered into the patient's permanent medical record:

• the date of administration
• the vaccine manufacturer
• the lot number of vaccine
• and the administering person's name, title, and address

Note:

• The ACIP, AAP, and the RotaTeq prescribing information is against readministering doses if a dose is regurgitated or spit out. Give any remaining dose(s) as per schedule.

Rotarix:

• Vaccine should be reconstituted before administration. Put infant in reclining position.
• The contents should be administered into the infant's inner cheek using the oral applicator.
• A replacement dose may be given at the same visit if most of the dose is spit out or regurgitated.
• Applicator and vaccine vial should be disposed of in a biological waste container.

RotaTeq:

• The dose should be gently squeezed from the ready-to-use dosing tube into the mouth of an infant toward the inner cheek until the dosing tube is empty.
• The empty tube and cap should be disposed of in a biological waste container after use.
• Replacement dose should not be done if an incomplete dose is given (eg, infant spits or regurgitates dose).
• Continue with any remaining doses of the series at the designated time interval.
• The vaccine should not be mixed or diluted with any other vaccine or solution.

Mechanism of action of Rotavirus vaccine (Rotarix):

• It is a live vaccine that replicates in the small intestine.
• This confers active immunity against rotavirus gastroenteritis. 
• Rotarix is indicated to prevent the rotavirus gastroenteritis that is caused by serotypes G1, G3, and G9 and RotaTeq to prevent rotavirus stomachitis caused by serotypes G1, G2, G3, and G4. 
• This vaccine may provide immunity to other rotavirus types.

Notice:It is unknown if there is a relationship between anti-inflammatory antibodies and protection against gastroenteritis. Seroconversion Rotarix: 77% to 87% infants have anti-rotavirus IgA antibodies within a period of 1 to 2 months after receiving the 2dose series. RotaTeq: After the 3dose regimen was completed, an increase of 3x in anti-rotavirus IgA in 93% to 100% infants was observed TimeAfter administration of the rotavirus vaccine, 71%-79% of protection against any type of rotavirus gastroenteritis was achieved over two seasons.

International Brand Names of Rotavirus vaccine:

• Rotarix
• RotaTeq
• Luo Te Wei
• RoatTeq
• Rotarix
• RotaTeq
• Rotateq

Rotavirus vaccine Brand Names in Pakistan:

No Brands Available in Pakistan