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Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
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Proposed clinical considerations for maternal RSVPreF
vaccine and nirsevimab
Jefferson Jones MD MPH FAAP
CDR USPHS
Co-Lead, Respiratory Syncytial Virus Vaccines -Pediatric/Maternal Work Group
Coronavirus and Other Respiratory Viruses Division
National Center for Immunization and Respiratory Diseases
September 22, 2023
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Proposed clinical considerations
for use of maternal RSV vaccine
3▪Maternal vaccine recommended for pregnant people during 32 through 36
weeks gestation, with seasonal administration
–During September through January in most of the continental United States
–In jurisdictions with seasonality that differs from most of the continental United
States (e.g., Alaska, jurisdictions with tropical climates), providers should follow
state, local, or territorial guidance on timing of administration
▪Maternal RSVpreF vaccine may be simultaneously administered with
other indicated vaccinations 1Proposed clinical considerations for use of maternal RSV
vaccine
1 https://www.cdc.gov/vaccines/hcp/acip -recs/general -recs/index.html.
Work Group considerations for
use of both maternal RSV
vaccine and nirsevimab
5▪As proposed, maternal RSV vaccine recommendation is for administration
beginning at 32 weeks gestation
▪From time of maternal vaccination, 14 days or more likely needed for
development and transplacental transfer of maternal antibodies to
protect the infant,1 and nirsevimab is recommended for infants born
within 14 days of vaccination
▪Therefore, the earliest an infant can be born and have maternal vaccine -
induced protection is at 34 weeks gestation
▪Infants born <34 weeks gestation will be recommended to receive
nirsevimabMaternal vaccination and considerations for use of
nirsevimab in infants born <34 weeks gestation
1 https://www.cdc.gov/vaccines/pregnancy/vacc -during -after.html .
6▪Protection from maternal vaccination may begin to wane after 3 or more
months (e.g., influenza and COVID -19 vaccines) 1–3
–Work Group members initially concerned that , with a year -round recommendation, infants born prior to the RSV
season and born to vaccinated mothers would require nirsevimab to boost protection when entering RSV season
▪However, because maternal RSV vaccine administration is recommended
during September through January, most infants of vaccinated mothers
will be born during RSV season (i.e., born during October –March)
▪Mothers of most infants born outside of RSV season (i.e., born during April
through September) will not have been vaccinated, and nirsevimab will be
recommended for these infantsMaternal vaccination and considerations for use of
nirsevimab in infants born outside of the RSV season
1 Kampmann NEJM 2023 . 2Nunes F1000Res 2018 . 3 Zerbo Nat Commun 2023 .
7▪Two products are available to protect infants from RSV lower respiratory tract
infection
▪For infants born to vaccinated mothers, the addition of nirsevimab may
provide incremental protection, but this is unknown
–No safety data on use of nirsevimab in infants born to vaccinated mothers, but nirsevimab trials
included infants with maternal infection -induced antibodies and risk likely minimal
▪For most infants, administering both products is not needed and would not be
a reasonable and efficient allocation of resources
▪Documentation of maternal vaccination status may not be available to the
infant's healthcare providerWork Group considerations for use of both maternal RSV
vaccine and nirsevimab
8▪Most Work Group members felt that pregnant people should be aware that
both maternal vaccination and nirsevimab are options when deciding whether
to be vaccinated
–However, healthcare providers of pregnant people may not have time or feel
equipped to discuss nirsevimab when counselling
▪In rare situations flexibility is needed for providers to be able to provide
nirsevimab when clinically warranted to infants born to vaccinated mothers
–Conditions in pregnant people resulting in an inadequate immune response to vaccine or decrease
in transplacental antibody transfer1
–Infants who have undergone cardiopulmonary bypass, leading to loss of maternal antibodies2
–Infants with sufficiently increased risk for severe disease to warrant nirsevimab because of the
potential increased benefitWork Group considerations for use of both maternal RSV
vaccine and nirsevimab ( cont )
1Palmerira Clin Dev Immunol 2012 . 2 Feltes J Pediatr 2003 .
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Proposed clinical considerations for use
of maternal RSV vaccine and
nirsevimab
10▪Either maternal vaccination or use of nirsevimab in the infant is
recommended to prevent RSV lower respiratory tract infection, but
administration of both products is not needed for most infants
▪Healthcare providers of pregnant people should provide
information onboth products and consider patient preferences when
determining whether to vaccinate the pregnant patient or to not
vaccinate and rely on administration of nirsevimab to the infant after birthProposed clinical considerations for maternal RSV vaccine
and nirsevimab
11Relative risks and benefits of maternal vaccination and
nirsevimab
Maternal RSV vaccine
Benefits
•Provides protection immediately after
birth
•May be more resistant to virus mutation
•Avoids injection of infant
Risks
•Protection reduced if fewer antibodies
produced or are transferred from mother
to baby (e.g., mother
immunocompromised or infant born soon
after vaccination)
•Potential risk of preterm birthNirsevimab
Benefits
•Studies of antibody levels suggest that
protection might wane more slowly
•Can provide antibodies directly if infant
receives less antibodies from mother
•No risk of adverse pregnancy outcomes
Risks
•Potentially limited availability during
2023 -2024 RSV seasonBoth products are safe and effective in preventing RSV lower respiratory infection in infants
12▪Nirsevimab is recommended for infants aged <8 months born
during or entering their first RSV season if
–Mother did not receive RSV vaccine or unknown if mother received RSV vaccine
–Mother vaccinated but infant born <14 days after vaccination
▪Nirsevimab is not needed for most infants born ≥14 days after
maternal vaccinationProposed recommendations for use of nirsevimab in setting of
an available maternal RSV vaccine
13▪Nirsevimab can be considered in rare circumstances when, per the
clinical judgment of the healthcare provider, the potential
incremental benefit of administration is warranted
–Infants born to pregnant people who may not mount an adequate immune response
to vaccination (e.g., people with immunocompromising conditions) or have
conditions associated with reduced transplacental antibody transfer (e.g., people
living with HIV infection)1
–Infants who have undergone cardiopulmonary bypass, leading to loss of maternal
antibodies2
–Infants with substantial increased risk for severe RSV disease (e.g.,
hemodynamically significant congenital heart disease, intensive care admission and
requiring oxygen at discharge)Circumstances for which nirsevimab can be considered when
mother has received RSV vaccine ≥14 days prior to birth
1Palmerira Clin Dev Immunol 2012 .2Feltes J Pediatr 2003 .
14Nirsevimab administration algorithm for children aged <8 months
on the day of administration
Nirsevimab
not neededNo
Any criteria not metMeet all 3 following criteria? (yes/no)
1.Either mother did not receive RSV vaccine during pregnancy ≥14
days prior to birth or maternal RSV vaccine status unknown1
2.Day of nirsevimab administration during October through March2
3.Never previously received dose of nirsevimab3
Nirsevimab
recommendedYes
All 3 criteria met
15Nirsevimab administration algorithm for children aged
<8 months on the day of administration footnotes
1For most infants age <8 months whose mother received RSV vaccine 14 or more days prior to birth,
nirsevimab is not needed. Nirsevimab can be considered in rare circumstances when, per the clinical
judgment of the healthcare provider, the potential incremental benefit of administration is warranted.
These situations include infants born to pregnant people who may not mount an adequate immune
response to vaccination (e.g., people with immunocompromising conditions) or have conditions associated
with reduced transplacental antibody transfer (e.g., people living with HIV infection), infants who have
undergone cardiopulmonary bypass leading to loss of maternal antibodies, and infants with substantial
increased risk for severe RSV disease (e.g., hemodynamically significant congenital heart disease, intensive
care admission and requiring oxygen at discharge).
2While the timing of the onset and duration of RSV season may vary, nirsevimab may be administered
October through the end of March in the majority of the continental United States. Providers may adjust
timing of administration based on guidance from public health authorities (e.g., CDC, health departments)
or regional medical centers. Although optimal timing of administration is just before the start of the RSV
season, nirsevimab may also be administered during the RSV season to infants and children who are age -
eligible. Infants born shortly before or during RSV season should receive nirsevimab within one week of
birth. Nirsevimab administration can occur during the birth hospitalization or in the outpatient setting.
Infants with prolonged birth hospitalizations related to prematurity or other causes should receive
nirsevimab shortly before or promptly after hospital discharge.
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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.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation
use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.
17Nirsevimab administration algorithm for children aged 8 through
19 months on day of administration1
No
Notall 3 criteria metMeet all 3 following criteria? (yes/no)
1.Child at increased risk for RSV disease2
2.Day of administration during October through March3
3.Has not received 1 dose of nirsevimab during current
RSV season and has not received 2 total doses4
Nirsevimab
recommendedNirsevimab not
neededYes
All 3 criteria met
18Nirsevimab administration algorithm for children aged 8 through 19 months on day of administration
footnotes
1Children at increased risk for severe disease aged <8 months of age and entering their second RSV season
should receive nirsevimab. For example, a child born in March should receive their first RSV dose shortly
after birth; they may be entering their second RSV season at 7 months of age in October and should not wait
until 8 months of age to receive nirsevimab.
2Children aged 8 –19 months recommended to receive nirsevimab during their second RSV season by ACIP:
-Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid
therapy, diuretic therapy, or supplemental oxygen) any time during the 6 -month period before the start of
the second RSV season
-Children with severe immunocompromise
-Children with cystic fibrosis who have either 1) manifestations of severe lung disease (previous
hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that
persist when stable) or 2) weight -for-length <10th percentile
-American Indian and Alaska Native children
19Nirsevimab administration algorithm for children aged 8 through 19 months on day of administration
footnotes
3While the timing of the onset and duration of RSV season may vary, nirsevimab may be administered
October through the end of March in the majority of the continental United States. Providers may adjust
timing of administration based on guidance from public health authorities (e.g., CDC, health departments)
or regional medical centers. Although optimal timing of administration is just before the start of the RSV
season, nirsevimab may also be administered during the RSV season to infants and children who are age -
eligible. Infants born shortly before or during RSV season should receive nirsevimab within one week of
birth. Nirsevimab administration can occur during the birth hospitalization or in the outpatient setting.
Infants with prolonged birth hospitalizations related to prematurity or other causes should receive
nirsevimab shortly before or promptly after hospital discharge.
4Children at increased risk for severe disease should not receive more than two doses of nirsevimab (one
dose [50mg or 100 mg depending on weight] for the first RSV season and one dose [two 100 mg injections]
for the second RSV season). Only one dose of nirsevimab is recommended per season (with exception for
children who undergo cardiac surgery with cardiopulmonary bypass). Nirsevimab is recommended for
children at increased risk for severe disease (as defined in footnote 4) during their first RSV season, including
if aged 8 -11 months if the child has not received nirsevimab during that RSV season.