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Rotavirus vaccine well tolerated among neonates
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Pentavalent rotavirus vaccine was well tolerated among infants in the neonatal ICU, with most post-vaccination symptoms attributed to preexisting symptoms, according to study findings in Pediatrics.
Heather M. Monk, PharmD, of the Children’s Hospital of Philadelphia, and colleagues reviewed data for infants (mean gestational age 32.6 weeks) vaccinated with pentavalent rotavirus vaccine (RV5; RotaTeq, Merck) between September 2008 and 2010. They compared data for vaccinated infants (n=96) with data for unvaccinated infants (n=801) hospitalized in the same pod, which contained five to seven beds. Researchers followed infants for 15 days after vaccination.
Most vaccinated infants received one dose of RV5, which was often administered with other scheduled vaccinations. Gastrointestinal symptoms were common after RV5 vaccination. Feeding intolerance increased from 52% to 56%; emesis increased from 44% to 49%; abdominal distention increased from 25% to 30%; and hematochezia increased from 8% to 13.5% among vaccinated infants. Diarrhea and fever were more common after vaccination; increasing from 35% to 52% and 0% to 8.3%, respectively.
The most frequent clinical changes among vaccinated infants included >diarrhea or increased stool frequency; feeding intolerance; or vomiting. None of the clinical changes were attributed to RV5. Vaccinated infants with fever had concomitant administration of other vaccines.
Of those who were unvaccinated, 51 (6.4%) had orders placed for bowel rest, IV antibiotics, and abdominal radiography within the 15-day exposure period to vaccinated infants. Most of these orders were placed prior to neonatal ICU admission, indicating gastrointestinal symptoms were present prior to potential exposure vaccinated infants. Ten unvaccinated infants had clinical status changes; of these, all had concomitant medical conditions.
“Preterm infants are at high risk for severe rotavirus gastroenteritis after discharge from the NICU. Administration of RV5 with routine 2-month vaccinations in this single hospital seems to have been tolerated by both [vaccinated infants] and neighboring [unvaccinated infants]; however, we cannot exclude the possibility that RV5 contributed to clinical changes in these infants. A large number of infants are not being vaccinated due to the age restriction and prolonged NICU hospitalization. A prospective study with stool rotavirus PCR testing and monitoring for symptoms of gastroenteritis is necessary to assess shedding, transmissibility, and safety of rotavirus vaccination in the NICU,” researchers concluded.
Disclosure: The researchers report no relevant financial disclosures.
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