New study findings published in The New England Journal of Medicine support administering a neonatal rotavirus vaccine beginning at birth, researchers said.
According to WHO, rotavirus is the No. 1 global cause of diarrheal disease in young children. Currently, the CDC recommends administering both available rotavirus vaccines — RotaTeq (Merck) and Rotarix (GlaxoSmithKline) — in multiple doses starting at age 2 months, with the minimum age for the first dose being age 6 weeks.
But RV3-BB, an Australian oral neonatal rotavirus vaccine, was previously found to improve rotavirus protection at birth in the first study ever to administer a human neonatal rotavirus vaccine in the early newborn period. In the new study, Julie E. Bines, MD, chair of pediatrics at the University of Melbourne, and colleagues report that RV3-BB protected against severe rotavirus gastroenteritis when given in three doses according to a neonatal schedule: at 0 to 5 days, 8 weeks and 14 weeks of age.
According to their report, vaccinating children against rotavirus at the time of birth is not a new concept.
“Birth is an established immunization time point in many countries,” Bines and colleagues wrote. “The use of a neonatal dose was investigated in the early phase of development of the rotavirus vaccine but was not pursued because of concerns regarding inadequate immune responses and safety.”
From January 2013 through July 2016, Bines and colleagues enrolled more than 1,600 babies from two locations in Indonesia in a phase 2b, randomized, double-blind, placebo-controlled trial. They randomly assigned participants to receive three doses of RV3-BB according to a neonatal or infant (8 weeks, 14 weeks, 18 weeks) schedule or placebo and assessed the vaccine’s efficacy against severe rotavirus gastroenteritis up to the age of 18 months.
Among 1,513 participants in the per-protocol population, severe rotavirus gastroenteritis occurred up to the age of 18 months in 5.6% of the participants in the placebo group, 1.4% in the neonatal-schedule vaccine group and in 2.7% in the infant-schedule vaccine group, Bines and colleagues reported.
Vaccine efficacy in the neonatal-schedule group was calculated to be 94% (95% CI, 56% to 99%) at age 12 months and 75% (95% CI, 44% to 91%) at age 18 months. In the infant-schedule group, it was 77% (95% CI, 31% to 92%) at age 12 months and 51% (95% CI, 7% to 76%) at age 18 months. Combined vaccine effectiveness including both groups was 63% (95% CI, 34% to 80%) at 18 months.
“Despite evidence of the success of rotavirus vaccines, more than 90 million infants still lack access to a rotavirus vaccine,” they wrote. “Barriers to global implementation of the vaccine include cost, suboptimal efficacy in low-income countries, and lingering safety concerns. An oral rotavirus vaccine administered at birth has the potential to address some of these challenges. – by Gerard Gallagher
Disclosure: Bines reports grants from the Bill and Melinda Gates Foundation and National Health and Medical Research Council, and other support from Victorian Government Operational Infrastructure Support during the conduct of the study, as well as other support from University of Maryland and grants from Commonwealth Serum Laboratories, GlaxoSmithKline, and Australian Commonwealth Department of Health and Aging outside the submitted work. Please see the study for all other authors’ relevant financial disclosures.