Rotavirus vaccine protected against rotavirus deaths in a 22-country pooled analysis

Design

Pooled analysis of test-negative case-control studies (MNSSTER-V), adjusted logistic regression

Population

27,252 children under 5 with acute gastroenteritis from 22 countries; 183 all-cause and 25 rotavirus-positive deaths

Primary outcome

Vaccine effectiveness against rotavirus-positive and all-cause gastroenteritis mortality

Effect

75.8% (95% CI 28.4 to 91.8) against rotavirus-positive death; 20.8% (95% CI -47.0 to 57.3) against all-cause death

The MNSSTER-V dataset pools test-negative case-control studies of rotavirus vaccine effectiveness in children under five seeking hospital care for acute gastroenteritis. This analysis used 27,252 children from 22 countries; 16 countries reported at least one in-hospital gastroenteritis death, giving 183 all-cause deaths and 25 rotavirus-positive deaths.

Among children aged at least 3 months who had received routine vaccines, at least one dose of rotavirus vaccine had an adjusted effectiveness of 75.8% (95% CI 28.4 to 91.8) against rotavirus-positive gastroenteritis death. Against all-cause gastroenteritis death it was 20.8% (95% CI -47.0 to 57.3), which includes no effect.

The estimates rest on few deaths, so the intervals are wide, and the design cannot rule out residual bias. The authors conclude rotavirus vaccines prevent rotavirus-positive deaths and that better delivery could reduce mortality. This is a pooled estimate across settings and vaccines, not an Indian estimate.

• Make sure infants receive rotavirus vaccine on schedule and on time; check the card at each visit.
• Tell parents that vaccination reduces severe rotavirus illness, but that it does not prevent all diarrhoea.
• Continue oral rehydration, zinc and early review for diarrhoea whatever the vaccine status.
• Refer children with dehydration, blood in stool or lethargy for assessment.

Why it matters

It adds mortality evidence to a vaccine whose benefit is usually shown for hospitalisation.

Don't overread it

The all-cause mortality estimate was not statistically distinguishable from zero, and the rotavirus-specific figure rests on 25 deaths.

The statistics, in plain English

Vaccine effectiveness of 75.8% means the odds of dying from rotavirus gastroenteritis were about three-quarters lower among vaccinated children. The interval of 28.4% to 91.8% is wide because only 25 rotavirus deaths were available. The all-cause estimate (20.8%, interval crossing zero) shows the data cannot confirm a benefit for deaths from any cause of diarrhoea.

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