In August 2023, nirsevimab, a monoclonal antibody against respiratory syncytial virus (RSV), was recommended for infants born during the RSV season, to be administered within a week of life either in the hospital or outpatient clinic.1 

Parental refusal of common newborn interventions persists in the United States.2–4  Because nirsevimab was newly approved, little is known about receipt rates or factors associated with refusal in well-newborn units. We sought to determine the rate of nirsevimab uptake in our well-newborn unit and characteristics of patients and families who refused nirsevimab during the newborn stay. We hypothesized that similarities exist between factors associated with refusal of common newborn interventions.

We reviewed charts of all newborns sequentially discharged from our hospital system (4 hospitals, combined annual delivery volume of ∼10,000) from December 15, 2023, through February 15, 2024. Nirsevimab was first offered in our network on October 26, 2023. Although nirsevimab administration was intermittently restricted during the 2023–2024 RSV season, nirsevimab was available to all newborns on our well-newborn units during the selected period (regardless of maternal RSV vaccination status). We report descriptive statistics of newborns who did and did not receive nirsevimab and unadjusted and adjusted relative risk with 95% confidence intervals using Poisson multivariable regression with robust standard errors.5,6  Although race is a social construct, we included race in the analysis because differences in nirsevimab receipt could potentially identify disparities. Our institutional review board determined this study exempt.

Of 1326 newborns, 57% received nirsevimab during the study period. Patient characteristics by site can be found in Supplemental Table 2. Factors significantly associated with nirsevimab receipt included public or other insurance (compared with private insurance); primary language other than English; being a first-time parent; receipt of ocular prophylaxis and hepatitis B vaccine (HBV) (Table 1). Newborns admitted to community hospital site 3 were more likely to receive nirsevimab compared with the tertiary care site. All infants who did not receive intramuscular (IM) vitamin K also did not get nirsevimab.

TABLE 1

Factors Associated With Receipt of Nirsevimab (N = 1326)

FactorTotalNo Nirsevimab (N/%)Received Nirsevimab (N/%)Unadjusted RR (95% CI)Adjusted RR (95% CI)
Maternal age, y 
 <35 892 380 (42.6) 512 (57.4) Ref Ref 
 ≥35 434 204 (47.0) 230 (53.0) 0.91 (0.80−1.03) 1.09 (0.97−1.21) 
Gestational age, wk 
 ≥37 (term) 1252 552 (44.1) 700 (55.9) Ref 
 35−37 (late preterm) 74 32 (43.2) 42 (56.8) 1.02 (0.78−1.33)  
Infant sex 
 Female 655 289 (44.1) 366 (55.9) Ref Ref 
 Male 671 295 (44.0) 376 (56.0) 1.00 (0.89−1.13) 0.99 (0.91−1.09) 
Delivery type 
 Cesarean 454 189 (41.6) 265 (58.4) Ref 
 Vaginal 872 395 (45.3) 477 (54.7) 0.92 (0.81−1.05)  
Insurance 
 Private 853 431 (50.5) 422 (49.5) Ref Ref 
 Public 442 146 (33.0) 296 (67.0) 1.53 (1.32−1.77) 1.26 (1.11−1.42) 
 Other 31 7 (22.6) 24 (77.4) 2.24 (1.16−4.31) 1.32 (1.07−1.61) 
Maternal racea 
 White 806 365 (45.3) 441 (54.7) Ref Ref 
 Black 192 83 (43.2) 109 (56.8) 1.05 (0.88−1.25) 0.91 (0.78−1.05) 
 Asian 75 26 (34.7) 49 (65.3) 1.31 (0.95−1.80) 1.13 (0.95−1.35) 
 Other/unknown 253 110 (43.5) 143 (56.5) 1.04 (0.89−1.22) 0.83 (0.73−0.94) 
Parity 
 ≥2 763 352 (46.1) 411 (53.9) Ref Ref 
 1 563 232 (41.2) 331 (58.8) 1.12 (0.99−1.27) 1.12 (1.02−1.23) 
Primary language 
 English 1167 546 (46.8) 621 (53.2) Ref Ref 
 Spanish 110 21 (19.1) 89 (80.9) 2.45 (1.66−3.62) 1.35 (1.17−1.55) 
 Other 49 17 (34.7) 32 (65.3) 1.35 (0.91−1.98) 1.07 (0.87−1.33) 
Location 
 Site 4b 593 247 (41.7) 346 (58.3) Ref Ref 
 Site 1c 262 126 (48.1) 136 (51.9) 0.87 (0.74−1.01) 0.83 (0.73−0.95) 
 Site 2c 320 179 (55.9) 141 (44.1) 0.75 (0.65−0.85) 0.83 (0.72−0.96) 
 Site 3c 151 32 (21.2) 119 (78.8) 1.97 (1.42−2.71) 1.24 (1.11−1.38) 
Length of stay, h 
 <48 630 293 (46.5) 337 (53.5) Ref Ref 
 48–72 460 186 (40.4) 274 (59.6) 1.15 (1.00−1.32) 1.06 (0.95−1.19) 
 >72 236 105 (44.5) 131 (55.5) 1.04 (0.89−1.23) 1.04 (0.88−1.22) 
Any breastmilk 
 No 188 83 (44.1) 105 (55.9) Ref Ref 
 Yes 1138 501 (44.0) 637 (56.0) 1.00 (0.84−1.19) 0.98 (0.86−1.12) 
Maternal RSV vaccine 
 Yes 99 41 (41.4) 58 (58.6) Ref 
 No 1227 543 (44.3) 684 (55.7) 0.94 (0.73−1.19)  
Ocular prophylaxis 
 No 59 50 (84.7) 9 (15.3) Ref Ref 
 Yes 1267 534 (42.1) 733 (57.9) 7.06 (3.50−14.23) 1.85 (1.03−3.31) 
Hepatitis B vaccine 
 No 153 130 (85.0) 23 (15.0) Ref Ref 
 Yes 1173 454 (38.7) 719 (61.3) 2.19 (1.99−2.42) 3.26 (2.16−4.92) 
IM vitamin K 
 No 13 13 (0) Ref * 
 Yes 1313 584 (43.5) 742 (56.5) 2.27 (2.13−2.41)  
FactorTotalNo Nirsevimab (N/%)Received Nirsevimab (N/%)Unadjusted RR (95% CI)Adjusted RR (95% CI)
Maternal age, y 
 <35 892 380 (42.6) 512 (57.4) Ref Ref 
 ≥35 434 204 (47.0) 230 (53.0) 0.91 (0.80−1.03) 1.09 (0.97−1.21) 
Gestational age, wk 
 ≥37 (term) 1252 552 (44.1) 700 (55.9) Ref 
 35−37 (late preterm) 74 32 (43.2) 42 (56.8) 1.02 (0.78−1.33)  
Infant sex 
 Female 655 289 (44.1) 366 (55.9) Ref Ref 
 Male 671 295 (44.0) 376 (56.0) 1.00 (0.89−1.13) 0.99 (0.91−1.09) 
Delivery type 
 Cesarean 454 189 (41.6) 265 (58.4) Ref 
 Vaginal 872 395 (45.3) 477 (54.7) 0.92 (0.81−1.05)  
Insurance 
 Private 853 431 (50.5) 422 (49.5) Ref Ref 
 Public 442 146 (33.0) 296 (67.0) 1.53 (1.32−1.77) 1.26 (1.11−1.42) 
 Other 31 7 (22.6) 24 (77.4) 2.24 (1.16−4.31) 1.32 (1.07−1.61) 
Maternal racea 
 White 806 365 (45.3) 441 (54.7) Ref Ref 
 Black 192 83 (43.2) 109 (56.8) 1.05 (0.88−1.25) 0.91 (0.78−1.05) 
 Asian 75 26 (34.7) 49 (65.3) 1.31 (0.95−1.80) 1.13 (0.95−1.35) 
 Other/unknown 253 110 (43.5) 143 (56.5) 1.04 (0.89−1.22) 0.83 (0.73−0.94) 
Parity 
 ≥2 763 352 (46.1) 411 (53.9) Ref Ref 
 1 563 232 (41.2) 331 (58.8) 1.12 (0.99−1.27) 1.12 (1.02−1.23) 
Primary language 
 English 1167 546 (46.8) 621 (53.2) Ref Ref 
 Spanish 110 21 (19.1) 89 (80.9) 2.45 (1.66−3.62) 1.35 (1.17−1.55) 
 Other 49 17 (34.7) 32 (65.3) 1.35 (0.91−1.98) 1.07 (0.87−1.33) 
Location 
 Site 4b 593 247 (41.7) 346 (58.3) Ref Ref 
 Site 1c 262 126 (48.1) 136 (51.9) 0.87 (0.74−1.01) 0.83 (0.73−0.95) 
 Site 2c 320 179 (55.9) 141 (44.1) 0.75 (0.65−0.85) 0.83 (0.72−0.96) 
 Site 3c 151 32 (21.2) 119 (78.8) 1.97 (1.42−2.71) 1.24 (1.11−1.38) 
Length of stay, h 
 <48 630 293 (46.5) 337 (53.5) Ref Ref 
 48–72 460 186 (40.4) 274 (59.6) 1.15 (1.00−1.32) 1.06 (0.95−1.19) 
 >72 236 105 (44.5) 131 (55.5) 1.04 (0.89−1.23) 1.04 (0.88−1.22) 
Any breastmilk 
 No 188 83 (44.1) 105 (55.9) Ref Ref 
 Yes 1138 501 (44.0) 637 (56.0) 1.00 (0.84−1.19) 0.98 (0.86−1.12) 
Maternal RSV vaccine 
 Yes 99 41 (41.4) 58 (58.6) Ref 
 No 1227 543 (44.3) 684 (55.7) 0.94 (0.73−1.19)  
Ocular prophylaxis 
 No 59 50 (84.7) 9 (15.3) Ref Ref 
 Yes 1267 534 (42.1) 733 (57.9) 7.06 (3.50−14.23) 1.85 (1.03−3.31) 
Hepatitis B vaccine 
 No 153 130 (85.0) 23 (15.0) Ref Ref 
 Yes 1173 454 (38.7) 719 (61.3) 2.19 (1.99−2.42) 3.26 (2.16−4.92) 
IM vitamin K 
 No 13 13 (0) Ref * 
 Yes 1313 584 (43.5) 742 (56.5) 2.27 (2.13−2.41)  

CI, confidence interval; IM, intramuscular; Ref, reference; RR, relative risk; RSV, respiratory syncytial virus.

a

Self reported.

b

Tertiary site.

c

Community hospital.

*

Not included in the final Poisson regression model.

In the first season of nirsevimab availability in our health system, the overall nirsevimab receipt rate was well below those of IM vitamin K, HBV, and ocular prophylaxis.7 

Parents who refused common newborn interventions (IM vitamin K, HBV, and ocular prophylaxis) were more likely to refuse nirsevimab. Families who spoke languages other the English had a higher acceptance of nirsevimab. Other studies have found that although Spanish-speaking families exhibit vaccine hesitancy, the sentiment was not associated with undervaccination.8,9  It is possible that providers present information differently to Spanish-speaking families. Although we expected that parents with other children might be more accepting of nirsevimab (because of increased knowledge of RSV and increased RSV exposure risks), we found that first-time parents in our study were slightly more likely to accept nirsevimab for their newborn.

Maternal RSV immunization was not associated with nirsevimab receipt. During this first season of both nirsevimab and maternal RSV vaccine availability, there may have been confusion among clinicians about whether nirsevimab was needed if the mother received RSV immunization during the pregnancy. We found differences in nirsevimab refusal rates between sites in our health system, which may be due to patient population, census, staffing, or procedures. This warrants further exploration to identify best practices.

Our study is limited by our single 4-hospital system and the sample size. It is possible that maternal receipt of RSV vaccine outside of our electronic medical record was not captured. Because this was the first season of nirsevimab availability for healthy newborns and behaviors may have been influenced by shortages, it is possible that findings in upcoming years may change. Because of the nature of this study, we were unable to determine whether all families were offered nirsevimab or whether newborns received nirsevimab after discharge. For newborns of mothers who received the RSV vaccine during pregnancy, we were unable to ascertain vaccination timing and physician interpretation of newborn eligibility.

We propose the need for qualitative studies to better understand parental concerns, preferences, and knowledge gaps about nirsevimab. Additionally, larger multisite studies through existing pediatric research networks should be leveraged to help inform pediatricians and newborn hospitalists about risk factors associated with parental concerns and in the context of other refusals to help us be better prepared for future years of nirsevimab.

Drs Aragona and Loyal conceptualized and designed the study, carried out the initial analyses, drafted the initial manuscript, and critically reviewed and revised the manuscript; and Dr Shabanova advised on and reviewed the analyses and critically reviewed and revised the manuscript.

1
RSV Immunization for Infants and Young Children: Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases
;
2023
2
Danziger
P
,
Skoczylas
M
,
Laventhal
N
.
Parental refusal of standard-of-care prophylactic newborn practices: in one center’s experience, many refuse one but few refuse all
.
Hosp Pediatr
.
2019
;
9
(
6
):
429
433
3
Loyal
J
,
Shapiro
ED
.
Refusal of intramuscular vitamin K by parents of newborns: a review
.
Hosp Pediatr
.
2020
;
10
(
3
):
286
294
4
Hill
HA
,
Elam-Evans
LD
,
Yankey
D
,
Singleton
JA
,
Kang
Y
.
Vaccination coverage among children aged 19–35 months—United States, 2017
.
MMWR Morb Mortal Wkly Rep
.
2018
;
67
(
40
):
1123
1128
5
Zou
G
.
A modified Poisson regression approach to prospective studies with binary data
.
Am J Epidemiol
.
2004
;
159
(
7
):
702
706
6
Chen
W
,
Qian
L
,
Shi
J
,
Franklin
M
.
Comparing performance between log-binomial and robust Poisson regression models for estimating risk ratios under model misspecification
.
BMC Med Res Methodol
.
2018
;
18
(
1
):
63
7
Loyal
J
,
Aragona
E
.
Trends in and documentation of refusal of common routine newborn interventions: 2013–2019
.
Hosp Pediatr
.
2021
;
11
(
9
):
962
967
8
Williams
JTB
,
Rice
JD
,
Lou
Y
, et al
.
Parental vaccine hesitancy and vaccination disparities in a safety-net system
.
Pediatrics
.
2021
;
147
(
2
):
e2020010710
9
Kempe
A
,
Saville
AW
,
Albertin
C
, et al
.
Parental hesitancy about routine childhood and influenza vaccinations: a national survey
.
Pediatrics
.
2020
;
146
(
1
):
e20193852

Competing Interests

CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest to disclose.

Supplementary data