From the Journals

Newborn oral rotavirus vaccine held effective


Key clinical point: A new oral rotavirus vaccine given to newborns was associated with significant reductions in the incidence of severe rotavirus gastroenteritis.

Major finding: A new oral rotavirus vaccine given within the first 5 days of life showed 94% efficacy at 12 months of age.

Data source: A randomized double-blind, placebo-controlled phase 2b trial in 1,513 healthy newborns.

Disclosures: The study was supported by the Bill and Melinda Gates Foundation, the National Health and Medical Research Council, PT Bio Farma, and the Victorian government’s Operational Infrastructure Support Program. Authors declared fees, grants and institutional support from the study sponsors, and three authors also declared a stake in the patent of the RV3-BB vaccine, which is licensed to PT Bio Farma.

Source: Bines JE et al. N Engl J Med. 2018;378:719-30.



A new oral rotavirus vaccine administered within the first few days of life appears effective against severe rotavirus gastroenteritis in newborns, a study has found.

A transmission electron micrograph shows intact rotavirus double-shelled particles. CDC/Dr. Erskine Palmer
When all three doses were administered, vaccine efficacy with the neonatal schedule was 75% by 18 months of age (P less than .001), while the efficacy of the infant schedule at 18 months was 51% (P = .03), and in the two groups combined, the efficacy was 63% (P less than .001) in the per-protocol analysis, the researchers reported in the New England Journal of Medicine. The results were similar in the intention-to-treat analysis.

At 12 months of age, the rotavirus vaccine showed an efficacy of 94% in participants who received all three doses of the neonatal schedule. That efficacy was 77% in those who received the doses on the infant schedule.

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