Rotavirus vaccine is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). It is approved for use in infants aged 6 to 24 weeks.

Your child should not receive the rotavirus vaccine if:

• He or she has had an allergic reaction after a previous dose of this vaccine.
• He or she is allergic to any component of the vaccine (see ingredient list in the leaflet).
• He or she has Severe Combined Immunodeficiency (SCID).
• He or she has a history of intussusception (a type of intestinal blockage).

Rotavirus vaccine contains:

• Five live rotavirus strains (G1, G2, G3, G4, and P1)
• Sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, and fetal bovine serum

Rotavirus vaccine is an oral vaccine used to help prevent rotavirus infection in children. Rotavirus infection can cause fever, vomiting, and diarrhea, which may become severe and lead to dehydration, hospitalization, and in some cases, death. The vaccine may not provide complete protection for all children, and it is not effective in children who are already infected with the virus.

Rotavirus is a major cause of severe acute gastroenteritis in infants and young children. There are two commonly available types of rotavirus vaccines. One is a live attenuated monovalent vaccine derived from a human strain (G1), which protects against gastroenteritis caused by G1, G3, G4, and G9 serotypes. The other is a live pentavalent human-bovine reassortant vaccine, which protects against G1, G2, G3, and G4 serotypes. Although porcine circovirus (PCV1 and PCV2) DNA has been detected in some rotavirus vaccines, current evidence indicates that it does not pose a safety risk to humans. The exact mechanism of action is not fully understood; however, it is known that the vaccine viruses replicate in the small intestine and stimulate active immunity.

The vaccine is administered orally. Your child will receive a total of 3 doses. The first dose is given at 6 to 12 weeks of age, the second dose 4 to 10 weeks later, and the third dose 4 to 10 weeks after the second dose. All doses should be completed by 32 weeks of age.The doctor will gently squeeze the vaccine into your child’s mouth. If the infant spits out part or all of the dose, it is not necessary to repeat the dose at that time.

All three doses must be completed by 32 weeks of age. Your doctor will advise the schedule for follow-up doses. It is important to attend all scheduled appointments. If a dose is missed, consult your doctor for further guidance.

Rotavirus vaccine can be administered at the same time as other vaccines, either as single vaccines or in combination, including: Diphtheria-tetanus-whole cell pertussis (DTwP), Diphtheria-tetanus-acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), inactivated polio vaccine (IPV), Hepatitis B vaccine, and Pneumococcal vaccine.

Co-administration with oral polio vaccine (OPV) does not affect the immune response to polio antigens. Although OPV given together may slightly reduce the immune response to rotavirus, there is no evidence that this affects clinical protection against severe rotavirus gastroenteritis. The immune response to rotavirus vaccine remains unchanged if OPV is given two weeks apart. Effects on the ability to drive or operate machinery are not applicable.

This vaccine should not be given to individuals with a history of intussusception or those diagnosed with Severe Combined Immunodeficiency (SCID). Minor infections, such as a common cold, are not considered a contraindication to vaccination.

The most commonly reported side effects after rotavirus vaccination include diarrhea, vomiting, fever, runny nose, sore throat, wheezing or coughing, and ear infections. Contact your doctor or go to the emergency department immediately if your child develops any of the following symptoms after vaccination, even weeks later, as they may indicate a serious condition called intussusception:

• Severe vomiting
• Severe diarrhea
• Intense abdominal pain
• Blood in the stool

Intussusception is a condition where a part of the intestine becomes blocked or twisted.

Other reported side effects include:

• Allergic reactions, which may be severe and include swelling of the face or mouth, difficulty breathing, wheezing, hives, or skin rash
• Kawasaki disease (a serious condition affecting the heart), with symptoms such as fever, rash, red eyes, red mouth, swollen glands, and swelling of hands and feet; if untreated, it may be fata

Pregnancy Category C. Animal studies have shown adverse effects on the fetus, and there are no adequate, well-controlled studies in humans. However, the potential benefits may justify use in pregnant women despite possible risks.

Before vaccination, a thorough review of medical history (especially previous vaccinations and any adverse reactions) along with a clinical examination is recommended. Parents or caregivers should seek medical attention promptly if any concerning symptoms appear. There is a possibility of transmission from recently vaccinated individuals; therefore, caution is advised for infants who have close contact with immunocompromised persons, such as those with malignancies or receiving immunosuppressive therapy. Recently vaccinated individuals should maintain proper personal hygiene.

Vaccines, Anti-sera & Immunoglobulin

Store the vaccine in a refrigerator at 2°C to 8°C, and protect the vials from light.