Centers for Disease Control and Prevention

Draft Interim Clinical Considerations: 

Nirsevimab

Jefferson Jones MD MPH FAAP, CDR USPHS

ACIP General Meeting

February 23, 2023
162

Goals of recommendations

 Provide simple, uniform recommendations that apply to most U.S. health 

care providers

 Provide flexibility for specific situations
163

Policy Question

 Should one dose of nirsevimab be recommended a) at birth for all 

infants born during October to March and b) when entering first RSV 

season and <8 months of age for all infants born during April through 

September?
164

Important considerations for timing of administration

 Efficacy beyond 150 days is unknown

 Majority of infants will only be eligible for a single dose of nirsevimab

 Only 1 dose is recommended per season

 If nirsevimab given too early, efficacy might wane during the RSV season

 For infants born during October–March, the optimal timing of nirsevimab

dosing is at birth

 For infants born during April-September, the ideal timing for nirsevimab

dosing is just before or near the start of the RSV season
165

Timing and location of nirsevimab administration

 For infants born during Oct–Mar, shortly after birth or as soon as possible

– Administration in hospital prior to discharge would be optimal to 

ensure early protection

– If not given prior to discharge, administration at first visit to primary 

care provider, ideally within 1 week of discharge

 For infants born Apr–Sep 

– Nirsevimab administration recommended during Oct-Nov (e.g., during 

regularly scheduled 2-, 4-, or 6-month well child visits)
166

Additional considerations

 During COVID-19 pandemic, interseasonal RSV transmission has 

occurred

 Work Group has expressed it is important to allow for flexibility of 

timing in nirsevimab administration during periods of significant 

interseasonal RSV transmission

 During 2023-2024 season, nirsevimab may not be available prior to 

October 2023
167

RSV-associated hospitalization rates in children aged 

0-11 months, New Vaccine Surveillance Network

0 1 2 3 4 5 6 7 8 9 10 11

2000-2005 13.5 25.9 14.3 10.3 8.9 4.8 4.1 5.6 3.4 3.8 3.7 2.9

2016-2020 17.6 31.1 22.3 15.6 13.6 10.9 9.6 8.0 7.3 8.4 6.0 6.0

0

5

10

15

20

25

30

35

40

Hospitalization rate per 1000 

Age in months

2000-2005 2016-2020

2000-2005: Adapted from Hall et al, Pediatrics 2013; 2016-2020: CDC unpublished data
168

Timing of beginning nirsevimab administration

 If increased RSV transmission is occurring locally in August or September, 

nirsevimab could be administered to eligible infants earlier than October, if 

available

 Local epidemiology data may be best indicator but recommend establishing 

evidence-based threshold

 National Respiratory and Enteric Virus Surveillance System (NREVSS) 

– May be used as one source of evidence

– Census Division-level or HHS regional-level data recommended1

– In NREVVS, >3% percent positivity of PCR tests for 2 consecutive weeks can 

indicate increased level of RSV detections

https://www.cdc.gov/surveillance/nrevss/index.html 1 Data from a single state may not be representative and should be interpreted with caution
169

Timing of ending nirsevimab administration

 To determine if nirsevimab should continue to be administered to newborns shortly 

after birth beyond March, local jurisdictions can alter administration schedules based on 

local transmission conditions with clear evidence of ongoing increased transmission

– Local data may be best indicator but recommend establishing evidence-based 

threshold

– NREVSS

• May be used as one source of evidence

• Census Division-level or HHS Region-level data recommended1

• For NREVVS data, <5% percent positivity of PCR tests for 2 consecutive weeks 

can indicate decreasing transmission

https://www.cdc.gov/surveillance/nrevss/rsv/index.html 1 Data from a single state may not be representative and should be interpreted with caution
170

Tropical climates

 Tropical climates (e.g., Hawaii, Guam, and US-affiliated Pacific Islands) 

may have RSV seasonality that differs from most of the continental US 

or is unpredictable

 Nirsevimab administration recommended to newborns shortly after 

birth throughout the year

 Certain jurisdictions with tropical climates (e.g., Puerto Rico) 

recommend birth dose nirsevimab administration during Aug–Mar. For 

infants born Apr-July, recommended in Aug–Sep.

 Consult with local, state, or territorial health department for 

recommendations
171

Alaska

 In Alaska, RSV seasonality is less predictable, and the duration of RSV 

activity is often longer than the national average

– Providers are advised to use RSV laboratory surveillance data generated 

by the state of Alaska to assist in determining the appropriate timing of 

nirsevimab

 The Alaska Department of Health will continue to provide clinicians with 

updated Alaska-specific guidance
172

Infants residing in remote areas

 Infants born during April–September and residing in remote areas (e.g., 

would require medical evacuation by air for severe disease) can be 

given nirsevimab as early as August if there is concern that the infant 

may not have access to nirsevimab at the recommended time (Oct–

Nov)
173

Policy question

 Should one dose of nirsevimab be recommended for children 

<20 months of age entering their second RSV season who are eligible 

for palivizumab in their second RSV season?
174

Population recommended for nirsevimab when 

entering 2nd RSV season

 Same groups eligible for palivizumab when entering 2nd RSV season per American 

Academy of Pediatrics recommendations

– Children with chronic lung disease of prematurity if require medical support 

(chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) 

during the 6-month period before the start of the second RSV season

– Children who are profoundly immunocompromised

– Children with cystic fibrosis with manifestations of severe lung disease 

(previous hospitalization for pulmonary exacerbation in the first year of life or 

abnormalities on chest XR or CT that persist when stable) or weight for length < 

10th percentile

 Other conditions are under review

American Academy of Pediatrics Committee on Infectious Diseases and Bronchiolitis Guidelines Committee. Updated guidance for palivizumab prophylaxis among 

infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics. 2014 A ug;134(2):415-20. 
175

Timing of nirsevimab administration for 2nd RSV 

season

 Nirsevimab should be administered during October to November

 Nirsevimab is not recommend to be used after the 2nd RSV season
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.