Clinical Tolerance of In-Neonatal Intensive Care Unit Administration of Rotavirus Vaccine

Courtney Briggs-Steinberg; David Aboudi; Gabrielle Hodson; Shetal Shah

doi:10.1055/s-0039-1698455

American Journal of Perinatology, Table of Contents

Am J Perinatol 2021; 38(05): 456-462
DOI: 10.1055/s-0039-1698455

Original Article

Clinical Tolerance of In-Neonatal Intensive Care Unit Administration of Rotavirus Vaccine

Courtney Briggs-Steinberg

¹Division of Neonatology, Department of Pediatrics, Staten Island University Hospital, Northwell Health, Staten Island, New York

²Department of Pediatrics, Zucker School of Medicine at Hofstra/Northwell, Staten Island, New York

,

David Aboudi

³Division of Newborn Medicine, Department of Pediatrics, Maria Fareri Children's Hospital at Westchester Medical Center, New York Medical College, Valhalla, New York

,

Gabrielle Hodson

⁴Department of Pharmacy, Maria Fareri Children's Hospital at Westchester Medical Center, New York Medical College, Valhalla, New York

,

Shetal Shah

³Division of Newborn Medicine, Department of Pediatrics, Maria Fareri Children's Hospital at Westchester Medical Center, New York Medical College, Valhalla, New York

› Author Affiliations

Abstract

Objective This article determines the tolerance of neonatal intensive care unit (NICU)-based administration of RV5 in premature infants. This article also aims to compare the rate of clinically significant adverse events after RV5 immunization to the standard 2-month shot series and to historical controls who were not immunized.

Study Design This is a retrospective case–control study of 201 premature infants immunized with RV5. Infants were evaluated for clinically significant events 7 days before and after immunization and were compared with events after the 2-month shot series and to 189 historical controls. Wilcoxon signed rank test and McNemar's test were used for all paired analysis.

Results There was no increase in number of infants with clinically significant adverse events when comparing after RV5 to prior to RV5, after the 2-month shot series, or to the historical controls.

Conclusion RV5 is well tolerated in premature infants and does not result in clinically significant adverse events when administered in NICU-hospitalized infants.

Keywords

rotavirus - neonatal intensive care unit - premature - immunization

Full Text

References

References
1 Dennehy PH. Rotavirus vaccines--an update. Vaccine 2007; 25 (16) 3137-3141
2 Payne DC, Staat MA, Edwards KM. et al. Active, population-based surveillance for severe rotavirus gastroenteritis in children in the United States. Pediatrics 2008; 122 (06) 1235-1243
3 Widdowson MA, Meltzer MI, Zhang X, Bresee JS, Parashar UD, Glass RI. Cost-effectiveness and potential impact of rotavirus vaccination in the United States. Pediatrics 2007; 119 (04) 684-697
4 Cortes JE, Curns AT, Tate JE. et al. Rotavirus vaccine and health care utilization for diarrhea in U.S. children. N Engl J Med 2011; 365 (12) 1108-1117
5 Newman RD, Grupp-Phelan J, Shay DK, Davis RL. Perinatal risk factors for infant hospitalization with viral gastroenteritis. Pediatrics 1999; 103 (01) E3
6 Committee on Infectious Diseases, American Academy of Pediatrics. Prevention of rotavirus disease: updated guidelines for use of rotavirus vaccine. Pediatrics 2009; 123 (05) 1412-1420
7 Cortese MM, Parashar UD. Centers for Disease Control and Prevention (CDC). Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2009; 58 (RR-2): 1-25
8 Roué J-M, Nowak E, Le Gal G. et al. Impact of rotavirus vaccine on premature infants. Clin Vaccine Immunol 2014; 21 (10) 1404-1409
9 Goveia MG, Rodriguez ZM, Dallas MJ. et al; REST Study Team. Safety and efficacy of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy premature infants. Pediatr Infect Dis J 2007; 26 (12) 1099-1104
10 Stumpf KA, Thompson T, Sánchez PJ. Rotavirus vaccination of very low birth weight infants at discharge from the NICU. Pediatrics 2013; 132 (03) e662-e665
11 Smith CK, McNeal MM, Meyer NR, Haase S, Dekker CL. Rotavirus shedding in premature infants following first immunization. Vaccine 2011; 29 (45) 8141-8146
12 Nallu LA, Ehrenkranz R, Vazquez M. Impact of length of neonatal intensive care unit hospitalization on receipt of rotavirus vaccine. Poster presented at: Annual Meeting of the Pediatric Academic Society; April 30–May 03, 2016; Baltimore, MD. Abstract 1521.586
13 Monk HM, Motsney AJ, Wade KC. Safety of rotavirus vaccine in the NICU. Pediatrics 2014; 133 (06) e1555-e1560
14 Hiramatsu H, Suzuki R, Nagatani A. et al. Rotavirus vaccination can be performed without viral dissemination in the neonatal intensive care unit. J Infect Dis 2018; 217 (04) 589-596
15 Hofstetter AM, Lacombe K, Klein EJ. et al. Risk of rotavirus nosocomial spread after inpatient pentavalent rotavirus vaccination. Pediatrics 2018; 141 (01) e20171110
16 Thrall S, Doll MK, Nhan C. et al. Evaluation of pentavalent rotavirus vaccination in neonatal intensive care units. Vaccine 2015; 33 (39) 5095-5102
17 Vesikari T, Matson DO, Dennehy P. et al; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354 (01) 23-33
18 Pahud B, Pallotto EK. Rotavirus immunization for hospitalized infants: are we there yet?. Pediatrics 2018; 141 (01) e20173499
19 Briggs-Steinberg C, Shah S. Rationale for in-neonatal intensive care unit administration of live, attenuated rotavirus vaccination. Am J Perinatol 2018; 35 (14) 1443-1448
20 Navar-Boggan AM, Halsey NA, Escobar GJ, Golden WC, Klein NP. Underimmunization at discharge from the neonatal intensive care unit. J Perinatol 2012; 32 (05) 363-367
21 Saari TN. American Academy of Pediatrics Committee on Infectious Diseases. Immunization of preterm and low birth weight infants. Pediatrics 2003; 112 (1 Pt 1): 193-198
22 Ladhani SN, Ramsay ME. Timely immunisation of premature infants against rotavirus in the neonatal intensive care unit. Arch Dis Child Fetal Neonatal Ed 2014; 99 (06) F445-F447