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Live oral attenuated rotavirus vaccine Pregnancy: Not applicable to the licensed population. §4.6 verbatim: 'Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and lactation. Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the vaccination schedule.'

Rotavirus vaccine

Brand names: Rotarix

The rotavirus vaccine is a live, oral vaccine given to infants to prevent rotavirus gastroenteritis.

Adult dose

Dose: Infants aged 6 to 24 weeks ONLY — no adult use. Licensed indication (§4.1 verbatim): 'active immunisation of infants aged 6 to 24 weeks for prevention of gastro-enteritis due to rotavirus infection'. §4.2 verbatim: 'The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses.' §4.6 verbatim: 'Rotarix is not intended for use in adults.'
Route: Oral use only — §4.2 verbatim: 'Rotarix is for oral use only. Rotarix should under no circumstances be injected.' Supplied as an oral suspension in a squeezable tube. The retrieved §4.2 prints NO volume and NO milligram figure for a dose; it refers administration instructions to §6.6, which was not retrieved, so no volume is stated here.
Frequency: Two doses, at least 4 weeks apart. §4.2 verbatim: 'The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.'
SCOPE: this page's only licensed population is infants; the regimen above is the infant course and is stated as such. PAEDIATRIC RESTRICTION, §4.2 verbatim: 'Rotarix should not be used in children over 24 weeks of age.' PRETERM INFANTS — the permission and the caution that sit together in this label must be read together. §4.2 verbatim: 'Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of gestational age (see sections 4.8 and 5.1).' §4.4 verbatim: 'The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born <= 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or delayed.' The matching §4.8 reaction is 'Apnoea in very premature infants (<= 28 weeks of gestation)', frequency not known. SPITTING / REGURGITATION, §4.2 verbatim: 'In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.' COMPLETING THE COURSE, §4.2 verbatim: 'It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with Rotarix. There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the first dose and another rotavirus vaccine is administered for the second dose or vice versa.' NO MAXIMUM DOSE is printed anywhere in the retrieved §4.2, so maxDose is deliberately left unset — the '24 weeks of age' limit is an AGE ceiling, not a dose ceiling, and must not be rendered as one. §4.2 also records: 'The use of Rotarix should be based on official recommendations' (§4.1), so the national schedule (which the retrieved SPC does not state) governs the actual visit ages.

Paediatric dose

Dose: Two oral doses. First dose from the age of 6 weeks; at least 4 weeks between doses; course preferably given before 16 weeks of age and must be completed by the age of 24 weeks. This is a fixed-count vaccine course — it is NOT weight-based, so no per-kg figure exists and none has been invented.
Route: Oral only — must under no circumstances be injected
Frequency: Two doses, at least 4 weeks apart
Not to be used in children over 24 weeks of age. May be given with the same posology to preterm infants born after at least 27 weeks of gestational age, but in very premature infants (≤ 28 weeks of gestation) consider the risk of apnoea and the need for respiratory monitoring for 48-72h — vaccination should not be withheld or delayed on that basis. If an infant spits out or regurgitates most of the dose, a single replacement dose may be given at the same visit. Complete the 2-dose regimen with the same vaccine. No volume figure is given in the retrieved §4.2.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Hypersensitivity after previous administration of rotavirus vaccines
  • History of intussusception
  • Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception
  • Subjects with Severe Combined Immunodeficiency (SCID) disorder
  • Postpone administration in subjects suffering from acute severe febrile illness — 'the presence of a minor infection is not a contra-indication for immunisation'
  • Postpone administration in subjects suffering from diarrhoea or vomiting
  • Must not be used in children over 24 weeks of age (§4.2); not intended for use in adults (§4.6)
  • Contains sucrose and glucose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this vaccine (§4.4)

Side effects

  • Common: diarrhoea; irritability
  • Uncommon: abdominal pain, flatulence; dermatitis
  • Very rare: intussusception; urticaria
  • Not known: anaphylactic reaction; haematochezia; gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder
  • Not known: 'Apnoea in very premature infants (≤ 28 weeks of gestation)' — pairs with the §4.4 respiratory-monitoring caution quoted in the dose notes
  • Intussusception, §4.8 verbatim: 'Data from observational safety studies performed in several countries indicate that rotavirus vaccines carry an increased risk of intussusception, mostly within 7 days of vaccination.'
  • In three placebo-controlled trials in which Rotarix was given alone, the incidence and severity of the solicited events collected over 8 days post-vaccination — diarrhoea, vomiting, loss of appetite, fever, irritability and cough/runny nose — were not significantly different from placebo, and no increase in incidence or severity was seen with the second dose
  • CAVEAT: §4.8 is TRUNCATED at the source-fetch limit in this bundle (cut off mid-sentence in the intussusception background-incidence figures), so this list is partial

Monitoring

  • Follow up any symptoms indicative of intussusception — 'severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or high fever' — since observational safety data indicate an increased risk, mostly within 7 days after rotavirus vaccination; advise parents/guardians to report such symptoms promptly to their healthcare provider
  • Very premature infants (born ≤ 28 weeks of gestation), particularly those with a previous history of respiratory immaturity: consider the potential risk of apnoea and the need for respiratory monitoring for 48-72h when giving the primary immunisation series. Vaccination should not be withheld or delayed
  • Appropriate medical treatment should always be readily available in case of an anaphylactic event following administration
  • Vaccination should be preceded by a review of the medical history, especially with regard to the contraindications, and by a clinical examination
  • Administration to infants with known or suspected immunodeficiency, including in utero exposure to an immunosuppressive treatment, should be based on careful consideration of potential benefits and risks
  • Vaccine virus is excreted in the stools after vaccination with peak excretion around the 7th day; give with caution to individuals with immunodeficient close contacts, and advise contacts of recent vaccinees to observe personal hygiene (e.g. hand washing after nappy changes)
  • In order to improve the traceability of biological medicinal products, record the name and batch number of the administered product

Clinical monograph

How it works

It contains attenuated rotavirus that replicates in the gut to stimulate a protective mucosal and systemic immune response against natural infection.

Prescribing in practice

  • Complete the course within the recommended early-infancy age window, as starting late is not advised owing to the small increased risk of intussusception with older age at vaccination.
  • It is contraindicated in infants with a history of intussusception or known severe combined immunodeficiency.
  • As a live oral vaccine, give particular caution around immunocompromised household contacts and follow national schedule guidance.

Monitoring

No laboratory monitoring is required; advise carers to watch for signs of intussusception after vaccination.

Counselling the patient

  • This vaccine is given as drops into your baby's mouth, not by injection.
  • Seek urgent medical care if your baby develops severe tummy pain, repeated vomiting or blood in the stools.
  • If your baby spits out or regurgitates the dose, ask your immunisation team for advice.

Evidence & guidelines

Rotavirus vaccination is part of the routine UK childhood immunisation programme.

Reference: UKHSA Green Book Ch.27b; Confirm identity and dosing against the manufacturer SPC (eMC) and NICE. Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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