Document text
Centers for Disease Control and Prevention
Draft Interim Clinical Considerations:
Nirsevimab
Jefferson Jones MD MPH FAAP , CDR USPHS
ACIP General MeetingFebruary 23, 2023
162Goals of recommendations
Provide simple, uniform recommendations that apply to most U.S. health
care providers
Provide flexibility for specific situations
163Policy 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?
164Important 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
165Timing 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)
166Additional 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
167RSV-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 6.00510152025303540Hospitalization rate per 1000
Age in months2000-2005 2016-2020
2000 -2005: Adapted from Hall et al, Pediatrics 2013; 2016 -2020: CDC unpublished data
168Timing 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.html1Data from a single state may not be representative and should be interpreted with caution
169Timing of ending nirsevimab administration
To determine if nirsevimab should continue to be administered to newborns shortly
after birth beyond March, l ocal 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.html1Data from a single state may not be representative and should be interpreted with caution
170Tropical 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 d uring Aug– Mar. For
infants born Apr -July, recommended in Aug –Sep.
Consult with local, state, or territorial health department for
recommendations
171Alaska
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
172Infants 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 th e recommended time (Oct–
Nov)
173Policy 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?
174Population 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.
175Timing of nirsevimab administration for 2ndRSV
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.