Document text
Centers for Disease Control and Prevention
Proposed Clinical Consideration Updates for
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
August 3, 2023
2Timing of nirsevimab
▪Providers should target administration1:
–In the first week of life for infants born shortly before and during the season
–Shortly before the start of the RSV season for infants aged <8 months
–Shortly before the start of the RSV season for children aged 8 –19 months who
are at increased risk of severe RSV disease
▪Based on pre -pandemic patterns, this means nirsevimab could be administered in
most of the continental United States from October through the end of March
▪Because timing of the onset, peak, and decline of RSV activity may vary, providers
can adjust administration schedules based on local epidemiology
1 While optimal timing for nirsevimab administration is shortly before the season, nirsevimab may be given at any time during t he RSV season for age -
eligible infants and children who have not yet received a dose
3Timing of nirsevimab for infants born shortly before or
during RSV season
▪Nirsevimab should be administered within 1 week of birth.
–Administration can be during the birth hospitalization or in the
outpatient setting
▪Infants with prolonged birth hospitalizations due to prematurity or other
causes should receive nirsevimab shortly before or promptly after
discharge
4Tropical climates and Alaska
▪Tropical climates may have seasonality that differs from most of the
continental United States or is unpredictable
–May include southern Florida, Hawaii, Guam, Puerto Rico, U.S. Virgin
Islands, and U.S. -Affiliated Pacific Islands
▪In Alaska, RSV seasonality is less predictable, and the duration of RSV
seasons is often longer than the national average
▪Providers in these jurisdictions should consult state, local, or territorial
guidance on timing of nirsevimab administration
5Coadministration with routine childhood vaccines
▪In accordance with CDC’s general best practices for immunizations,
simultaneous administration of nirsevimab with age -appropriate vaccines
is recommended
▪In clinical trials, when nirsevimab was given concomitantly with routine
childhood vaccines, the safety and reactogenicity profile of the
coadministered regimen was similar to the childhood vaccines given alone1
▪When coadministered , nirsevimab is not expected to interfere with the
immune response to vaccines2
1FDA label for nirsevimab ; 2Espocito Front Immunol. 2021 Aug 11;12:708939.
6Children aged 8 –19 months recommended to receive
nirsevimab when entering their second RSV season because of
increased risk of severe disease
▪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 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
weight -for-length <10th percentile
▪American Indian and Alaska Native children
7Nirsevimab recommendations for infants and children
at increased risk of severe RSV
▪Nirsevimab is recommended for infants aged <8 months born during or
entering their first RSV season, including those recommended to receive
palivizumab by AAP1
▪Nirsevimab is recommended for children aged 8 –19 months who are at
increased risk of severe RSV disease and entering their second RSV season,
including those recommended to receive palivizumab by AAP1
▪Per FDA label, children who have received nirsevimab should not receive
palivizumab for the same RSV season2
1American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncytial Virus.] In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book
: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of Pediatrics, 2021 .
2FDA label for nirsevimab
8Precautions and Contraindications
▪Providers administering nirsevimab should follow ACIP's general best
practice guidelines for immunization1
▪Nirsevimab should not be administered to persons with a history of severe
allergic reaction (e.g., anaphylaxis) after a previous dose or to a product
component (contraindication)
1 For immunization information systems, state or local guidance should be followed
9Consumers and health care providers reporting
suspected adverse reactions for nirsevimab
▪Report suspect adverse reactions following the administration of
nirsevimab without coadministration with any vaccine to MedWatch
–Reports can be submitted to MedWatch online at
www.fda.gov/medwatch or by phone at 1 -800-FDA-1088
▪Report suspect adverse reactions following co -administration of nirsevimab
with any vaccine to the Vaccine Adverse Event Reporting System (VAERS)
–Please specify that the patient received nirsevimab on the VAERS form,
specifically, in Section 9: ‘Prescriptions, over -the-counter medications,
dietary supplements, or herbal remedies being taken at the time of
vaccination’
10Acknowledgements
Meredith McMorrow
Lauren Roper
Katherine Fleming -Dutra
Mila Prill
Amanda Payne
Danielle Moulia
Morgan Najdowski
David Hutton
Jamie Pike
Ismael Ortega -Sanchez
Andrew Leidner
Sara Oliver
Monica Godfrey
Evelyn Twentyman
Rebecca Morgan
Doug Campos -Outcalt
Sherry Farr
Karrie Finn -DowningMelissa Glidewell
Eric Griggs
Emilia (Emily) Koumans
Matt Oster
Eghosa (Ivy) Oyegun
Francena Scott
Olga Varechtchouk
Lori Moore
Roua El Kalach
Eric Larson
Harris LaTreace
Michelle Ruslavage
Hannah Rosenblum
James Singleton
Carla Black
Sarah Meyer
Derrell Powers
Raigan WheelerMichael Melgar
Amadea Britton
Erica Reott
Samuel Graitcer
Jeanne Santoli
Jill Moses
Jamie Mells
Dawona Hough
Paul Lucas
Michelle Banks
Arthur Bayo
Nancy Fenlon
Rebecca Miller
Elizabeth Walker
Suzanne Johnson -DeLeon
JoEllen Wolicki
Elizabeth Greene
Neil MurthyPatricia Wodi
Sarah Cutchin
Elisha Hall
Sarah Schillie
Andrew Kroger
Melissa Barnett
Dale Babcock
Rosa Herrera
Richard Quartarone
Stuart Myerburg
Melissa Taylor
Sarah Morales
Barbara Mahon
All members of the ACIP
Mat/Peds RSV Workgroup
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.
Centers for Disease Control and Prevention
Workgroup Considerations and Voting
Language for 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
August 3, 2023
13Safety monitoring for nirsevimab
▪FDA will monitor safety reports submitted by patients, providers, and the
manufacturer to the FDA Adverse Event Reporting System (FAERS) and
Vaccine Adverse Event Reporting System (VAERS)
▪FDA will monitor other data sources, including the scientific literature,
applicant’s periodic safety reports, ongoing clinical studies, and potentially
other sources (e.g., medical billing and electronic health records)
▪CDC will monitor reports submitted to VAERS that involve simultaneous
administration of nirsevimab with childhood vaccines and will also monitor
the safety of nirsevimab in the Vaccine Safety Datalink (VSD)
June 8, 2023 Meeting of the Antimicrobial Drugs Advisory Committee -FDA Presentations
14Effectiveness monitoring for nirsevimab
▪ CDC will leverage existing COVID -19 vaccine effectiveness (VE) platforms
▪ New Vaccine Surveillance Network (NVSN)
–Active surveillance network for acute respiratory infection at 7 pediatric medical centers that
can assess effectiveness against outpatient and emergency department visits and
hospitalization
–Capture nirsevimab receipt through parent interview, medical record review at the primary
care provider and birth hospital, and state immunization information systems (IIS)
▪ Virtual SARS -CoV-2, Influenza, and Other respiratory viruses Network (VISION)
–Multi -site, electronic healthcare record -based network that can assess effectiveness against
emergency department/urgent care visits, hospitalization, and critical illness
–Nirsevimab effectiveness analyses will be limited to integrated healthcare system sites that will
have more complete capture of nirsevimab receipt (i.e., through IIS linkage and claims data)
▪ CDC will monitor nirsevimab effectiveness throughout the season, but end of season estimates will
likely be most accurate. Power to estimate effectiveness depends on uptake and RSV incidence
15RSV genomic surveillance
▪Mutations resulting in nirsevimab resistance have been rarely reported1,2
▪Sanofi and AstraZeneca sponsoring INFORM -RSV, a global genomic
surveillance study in children aged < 5 years to monitor evolution of RSV
strains, F protein antigenic sites, and their relationships with clinical
features of RSV disease3
▪CDC planning genomic RSV surveillance of pediatric and adult RSV
specimens, including whole genomic surveillance
–Will monitor for changes in F protein that might result in nirsevimab
resistance
1Ahani et al. Nat Comm 2023 14:4347; 2Wilkins et al. Lancet Infect Dis 2023; 23: 856 –66; 3Tabor 2020 Dec 17;59(1):e01828 -20.
16Work Group considerations for infants aged <8 months
born during or entering RSV season
▪Nirsevimab is safe and effective in reducing the risk of RSV disease, including
hospitalization due to RSV
▪Shared concerns as outlined in implementation considerations presentation
▪Use of nirsevimab would be a reasonable and efficient allocation of resources
–Many work group members prefer lower cost per dose
17Work Group considerations for children aged 8 –19
months who are at increased risk of severe RSV disease
and entering their second RSV season
▪Limited efficacy and safety data for the use of nirsevimab for children in their
second RSV season
▪Limited data on the burden of severe disease in the second RSV season for children
with chronic conditions
▪Support recommendation of nirsevimab being given to children aged 8 –19 months
who are entering their second RSV season for those who are recommended for
palivizumab by American Academy of Pediatrics in their second RSV season and for
American Indian and Alaska Native children
18Proposed ACIP Voting Language
▪Infants aged <8 months born during or entering their first RSV season are
recommended to receive one dose of nirsevimab (50 mg for infants <5 kg
and 100 mg for infants ≥5 kg)
▪Children aged 8–19 months who are at increased risk of severe RSV disease
and entering their second RSV season are recommended to receive one
dose of nirsevimab (200 mg)
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.