Rotavirus Vaccine

Registered South African indications:

• Prevention of rotavirus gastroenteritis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity after previous administration of rotavirus vaccines
• Individuals with severe combined immunodeficiency disease (SCID)
  - Cases of gastroenteritis associated with vaccine virus have been reported post-marketing in infants with severe combined immunodeficiency (SCID)

Cautions

• Pregnancy
• Infants with gastrointestinal illnesses
• Infants with growth retardation
• Immunocompromised infants 
• Immunocompromised close contacts
• Premature infants
• Fructose intolerance
• Glucose-galactose malabsorption
• Sucrase-isomaltase insufficiency

Not indicated for use in adults

Paed. forms avail. in SA and covered in this monograph: sol

EPI Schedule 2016

Prevention of rotavirus gastroenteritis
-Rotavirus: Pentavelent live reassorted 

Younger than 6 weeks

• Not established for use

Older than 6 weeks

• Oral (sol): 1st dose: 2ml, as a single dose given at 6-12wks of age; 2nd and 3rd dose: 2ml, as a single dose given at intervals of at least 4wks

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All three doses should be complete by 32 weeks of age

May be given to preterm infants according to their chronological age

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Do not mix with any other vaccines or solutions; Do not reconstitute or dilute

Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty

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DO NOT inject dose

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Prevention of rotavirus gastroenteritis
-Rotavirus: Live attenuated

Younger than 6 weeks

• Not established for use

Older than 6 weeks

• Oral (sol): 1st dose: 1.5ml, as a single dose given at 6wks of age; 2nd dose: 1.5ml, as a single dose given after an intervals of at least 4 weeks

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All three doses should be complete by 24 weeks of age

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Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty

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DO NOT inject dose

Pregnancy

• FDA Pregnancy Category Not Rated (NR)

Breastfeeding

• Not indicated for use in adults

Renal Impairment

• No dose adjustment recommended 

Hepatic Impairment

• No dose adjustment recommended

Elderly

• Not indicated for use in geriatric patients

Gastrointestinal Disorders

• Diarrhoea
• Abdominal pain
• Flatulence
• Intussusception 
• Haematochezia
• Gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disorder(SCID)

Respiratory Disorders

• Apnoea in very premature infants (≤ 28 weeks of gestation) 

Skin and Subcutaneous Tissue Disorders

• Dermatitis

Others

• Irritability

Oral polio vaccine

None routine

The rotavirus vaccine is an oral vaccine that replicates in the small intestine and induces immunity against rotavirus gastroenteritis.

Rotavirus, Live attenuated

Solution

• Rotarix liquid oral vaccine (GSK) originator

Rotavirus, Pentavelent, Live, reassorted

Solution

• RotaTeq (MSD) originator