ROTARIX is an oral vaccine used for the prevention of rotavirus infections, which are a leading cause of severe diarrhea in infants and young children. The vaccine contains a live, attenuated strain of rotavirus, which helps to build immunity against the virus without causing the disease itself. ROTARIX is administered in two doses, typically starting at 6 weeks of age, to prevent rotavirus gastroenteritis, a condition that can lead to dehydration, hospitalization, and in severe cases, death, particularly in young children. The vaccine is available in liquid form, packaged for oral administration.

Pharmaceutical Properties:

• Active Ingredient: ROTARIX contains the live, attenuated human rotavirus strain.

• Appearance: The vaccine is a clear to slightly opalescent liquid, typically colorless to pale yellow in appearance.

• Formulation: ROTARIX is formulated for oral administration. Each dose is delivered as a single 1.5 ml volume of liquid.

• Stability: The vaccine should be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) and should not be frozen. It should be used within the expiry date indicated on the packaging.

Indications for Use:

ROTARIX is primarily indicated for the prevention of rotavirus gastroenteritis in infants. It is recommended as part of the routine vaccination schedule for infants aged 6 to 24 weeks to provide protection against rotavirus infection, which is a major cause of severe diarrhea, vomiting, and dehydration in children. The vaccine helps prevent hospitalizations due to severe diarrhea, which can lead to dehydration and other complications.

Mechanism of Action:

ROTARIX works by stimulating the immune system to produce an immune response against rotavirus. When administered, the vaccine contains a weakened form of the virus that does not cause illness. This weakened virus activates the immune system, prompting the body to produce antibodies. If the child is later exposed to the actual rotavirus, these antibodies will recognize and neutralize the virus, preventing the development of severe symptoms. The immune response primarily targets the viral proteins that are involved in infection, helping to prevent rotavirus-related gastroenteritis.

Clinical Protocol in Dubai:

1. Patient Selection:

   • ROTARIX is recommended for infants between the ages of 6 weeks and 6 months. It is typically given to infants as part of their regular vaccination schedule.

   • ROTARIX should not be administered to infants who are immunocompromised or who have a history of severe allergic reactions to the vaccine or its components.

   • It is also contraindicated for infants who have a history of intussusception (a form of bowel obstruction).

2. Dosage and Administration:

   • First Dose: The first dose should be administered at 6 weeks of age.

   • Second Dose: The second dose should be given at least 4 weeks after the first dose. The entire vaccination schedule should be completed by 24 weeks of age.

   • Route of Administration: ROTARIX is administered orally. The vaccine should be given directly into the infant’s mouth using the provided dropper or syringe.

   • Precautions: Care should be taken to ensure that the entire dose is administered. The vaccine should not be administered to infants who are above the recommended age for vaccination (i.e., older than 24 weeks).

3. Monitoring:

   • Infants should be observed for at least 15 minutes after the vaccination to monitor for any immediate adverse reactions, especially allergic reactions.

   • No routine monitoring is necessary after the second dose, but parents should be instructed to seek medical attention if the child exhibits unusual symptoms.

4. Precautions and Contraindications:

   • Infants with a history of severe allergic reactions to ROTARIX or any of its components should not receive the vaccine.

   • Infants with a history of intussusception or other gastrointestinal disorders should not receive ROTARIX.

   • Special caution is required when administering ROTARIX to infants with weakened immune systems.

Other Characteristics:

• Adverse Effects:

  • The most common side effects of ROTARIX are mild and include irritability, mild diarrhea, and fever. These side effects are typically transient and resolve without medical intervention.

  • Rare side effects include more severe allergic reactions such as anaphylaxis, which require immediate medical attention.

  • There is also a very small risk of intussusception, a type of bowel obstruction, but this risk is much lower than with previous rotavirus vaccines.

• Efficacy:
  ROTARIX has shown high efficacy in preventing rotavirus gastroenteritis. Clinical studies demonstrate a significant reduction in the incidence of severe diarrhea, hospitalizations, and associated complications caused by rotavirus infection.

ROTARIX is an essential vaccine for preventing rotavirus infections in infants, significantly reducing the risk of severe diarrhea and related complications, including dehydration and hospitalization. It is safe and effective when administered according to the recommended vaccination schedule. The vaccine provides broad protection against multiple strains of rotavirus, ensuring that infants are shielded from a potentially life-threatening illness. As with all vaccines, it is crucial to follow the recommended administration schedule and monitor for any adverse effects to ensure the best health outcomes for infants.