Rotarix

Description

Rotarix is a monovalent, live attenuated human rotavirus vaccine derived from the human 89-12 strain (G1P[8]) used to prevent rotavirus gastroenteritis. The vaccine is provided as a clear, colorless oral suspension, ready for use. It also contains an antacid component (calcium carbonate) to protect the vaccine virus from stomach acid upon ingestion.

Active Ingredient / Composition

• Live attenuated human rotavirus (G1P[8]).

• Contains at least 10^6.0 CCID₅₀ of the virus per dose.

• Excipients include sucrose, buffer salts, Dulbecco’s Modified Eagle Medium (DMEM) components, and calcium carbonate in the diluent.

Mechanism of Action

After oral administration, the attenuated rotavirus replicates in the small intestine and induces immune responses that protect against future infection by rotavirus strains. The exact immunologic correlates of protection are not fully defined.

Indications

Rotarix is indicated for active immunization of infants, beginning at 6 weeks of age, to prevent rotavirus gastroenteritis caused by G1 and non-G1 strains such as G3, G4, and G9.

Dosage & Administration

• Series consists of two oral doses, given at least 4 weeks apart.

• Must be completed by 24 weeks of age.

• Oral dosing applicator presentation: 1.5 mL per dose (no reconstitution required).

• Vial + diluent presentation: must be reconstituted; 1 mL is administered orally.

• If most of the dose is spit out or regurgitated, a replacement dose may be given once at the same visit.

• Breastfeeding does not interfere with the vaccine’s effectiveness.

Contraindications

• Hypersensitivity to any component of the vaccine.

• History of intussusception or congenital malformation of the gastrointestinal tract that predisposes to intussusception.

• Severe Combined Immunodeficiency (SCID).

• Hypersensitivity reaction to a prior dose of a rotavirus vaccine.

Precautions & Warnings

• Monitor for adverse events post-vaccination, such as intussusception (rare).

• For oral use only; not for injection.

• Avoid mixing with other solutions that may inactivate the vaccine.

• Any unused vaccine or waste material should be discarded according to local guidelines.

Side Effects / Adverse Reactions

Common: irritability, fever, diarrhea, vomiting, nasopharyngitis, upper respiratory tract infection, anorexia.
Rare: intussusception, severe allergic reactions.

Efficacy / Clinical Data

• Rotarix significantly reduces the incidence of rotavirus gastroenteritis, including severe cases, compared with placebo.

• Large-scale clinical studies in Latin America and Finland (over 63,000 infants) found no increased risk of intussusception within 31 days post-vaccination.

Storage & Handling

• Store refrigerated at 2–8 °C.

• Do not freeze.

• Protect from light.

• Inspect for particulate matter or discoloration; discard if abnormal.

Doctor’s Review

Rotarix is a safe and effective oral vaccine for preventing rotavirus gastroenteritis in infants. The simple two-dose schedule improves compliance and facilitates use in routine immunization programs. By inducing intestinal immunity, Rotarix reduces hospitalizations and severe illness due to rotavirus infections. While its safety record is strong, healthcare providers should remain alert for rare but potential adverse effects like intussusception.

Disclaimer

This information is provided for educational purposes only and does not substitute medical advice. Always consult a qualified healthcare professional for vaccination guidance and treatment decisions.