Rotavirus vaccine (study note)

Vaccine

• Rotarix® – a live attenuated vaccine
• Storage – +2°C to +8°C and protected from light.
• Presentation – oral suspension

Efficacy– Protect against gastroenteritis due to rotavirus serotypes G1P, G2P, G3P, G4P, and G9P; some efficacy against uncommon rotavirus genotypes G8P and G12P.
– Over 85% effective at protecting against severe rotavirus gastroenteritis in the first two years of life.

Administration of the vaccine

Rotarix® should not be given to infants under 6 weeks of age.
WHO recommends infants should receive their first dose only if they are younger than 15 weeks (The reason for 15 weeks is to minimise the risk of intussusception.)
It should not be given after 24 weeks (24 weeks and zero days of age or older).

UK immunisation schedule:

The first dose (1.5ml PO) at 8 weeks orally and the second (1.5ml PO) after at least 4 weeks.
It is preferable to complete 2 doses of Rotarix® before 16 weeks of age.

• It can be given with other vaccines in the infant immunisation programme, including BCG (although the rotavirus vaccine is a live vaccine, it can be given with BCG as it is not an injectable vaccine).
• There is no relation to food/drink. A single replacement dose can be given if the infant spits out/regurgitates most of the vaccine.

If infants receive their first dose before 15 weeks, they should receive their 2nd dose by 24 weeks, keeping a 4 weeks gap.

• If an infant inadvertently receives a vaccine dose at or after 15 weeks, they should receive their 2nd dose 4 weeks later, provided they are <24 weeks old by that time.
• No specific clinical action needs to be taken if the first dose of vaccine is inadvertently given after 15 weeks and zero days of age or if the second dose is given after 24 weeks of age. Immunisers should be reminded of the age restrictions for Rotarix®.
• If the course is interrupted, it should be resumed but not repeated, provided the second dose can be given before the 24-week cut-off.

Contraindication

Anaphylaxis	Infants with a confirmed anaphylactic reaction to a previous dose of rotavirus vaccine or any components of the vaccine
Intussusception	infants with a previous history of intussusception or who have a malformation of the gastrointestinal tract that could predispose them to intussusception
Age	infants aged 24 weeks and zero days of age or older
SCIDS	infants with severe combined immunodeficiency (SCID) disorder
Hereditary diseases	infants with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Administration of rotavirus vaccine should be postponed in infants suffering from:
● Acute severe febrile illness,
● Acute diarrhoea or vomiting. This is to ensure that the vaccine is not regurgitated or passed through the intestines too quickly, reducing the vaccine’s effectiveness.

Specific group

Premature infants or Preterm babies	Immunisations at the appropriate chronological age (without correction for prematurity) of at least six weeks, as per the schedule if the infant is clinically stable.
HIV	Immunisations at the appropriate chronological age (without correction for prematurity) of at least six weeks, as per the schedule, if the infant is clinically stable.

Adverse reaction

Common: diarrhoea and irritability
Other: vomiting, abdominal pain, flatulence, skin inflammation, regurgitation of food, fever and loss of appetite
Possible: Intussusception (0.002%) – WHO recommends 1st dose must be given before 15 weeks to reduce the risk.
Rare: anaphylaxis