title: Evaluating the potential risks and benefits of infant rotavirus vaccination in England.
abstract: Rotarix(®), a vaccine for the prevention of gastroenteritis in young children, was introduced in England in July 2013. At around this time, an elevated risk of intussusception (a cause of bowel obstruction) was reported among infants vaccinated in Australia and the USA. A risk-benefit analysis compared potential vaccine-related risks (additional intussusception admissions and deaths) with estimated vaccine benefits (prevented rotavirus general practitioner visits, emergency visits, admissions and deaths) in the 2012 birth cohort. Detailed data from England included the incidence of intussusception events aged <2 years by week of age, the coverage of vaccination aged <2 years by week of age, and the incidence of rotavirus gastroenteritis (RVGE) events aged <5 years by week of age. Recent estimates of vaccine-related risk from Australia were applied during the 1-21 day period after the first and second dose of vaccination. Rotarix(®) is estimated to cause one additional intussusception admission in every 18,551 vaccinated English infants (5th and 95th percentiles, 6728-93,952), equivalent to 35 (7-98) additional intussusception admissions each year. The vaccine is estimated to prevent three rotavirus deaths, 13,000 rotavirus admissions, 27,000 rotavirus emergency visits and 74,000 rotavirus GP consultations in children aged <5 years, and lead to annual savings of over £11 million, each year. We estimate 375 (136-1900) fewer RVGE admissions for every additional intussusception admission, and 88 (18-852) fewer RVGE deaths for every additional intussusception death. The estimated benefits of Rotarix(®) vaccination would greatly exceed the potential risk in England.
authors.affiliation: Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK. Electronic address: andrew.clark@lshtm.ac.uk.
authors.forename: Andy
authors.initials: A
authors.lastname: Clark
authors.affiliation: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK; Statistics Modelling and Economics Department, Health Protection Directorate, Public Health England, London NW9 5EQ, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Jit
authors.affiliation: Statistics Modelling and Economics Department, Health Protection Directorate, Public Health England, London NW9 5EQ, UK.
authors.forename: Nick
authors.initials: N
authors.lastname: Andrews
authors.affiliation: Department of Primary Care and Public Health, School of Public Health, Imperial College, London W6 8RP, UK.
authors.forename: Christina
authors.initials: C
authors.lastname: Atchison
authors.affiliation: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
authors.forename: W John
authors.initials: WJ
authors.lastname: Edmunds
authors.affiliation: Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London WC1H 9SH, UK.
authors.forename: Colin
authors.initials: C
authors.lastname: Sanderson
mesh_terms: D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D004739:England / Q000453:epidemiology; D005759:Gastroenteritis / Q000517:prevention & control*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007443:Intussusception / Q000453:epidemiology*; D018570:Risk Assessment; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects* / Q000627:therapeutic use*; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: Intussusception; Risk-benefit analysis; Rotavirus; Vaccination