04 Vaxelis Collins 508

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Work Group Considerations
Jennifer Collins MD, MSc
Co-Lead, ACIP Hib/Meningococcal Vaccines Work Group
February 29, 2024National Center for Immunization & Respiratory Diseases
Policy question
▪Should Vaxelis (DTaP -IPV-Hib-HepB ) be included with 
PedvaxHIB  in the preferential recommendation for 
American Indian and Alaska Native infants?
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3▪574 federally recognized tribes in the United States
–Listening to tribal communities is very important
–CDC’s Office of Tribal Affairs and Strategic Alliances 
(OTASA) is helping facilitate 
▪ACIP preferential recommendations must be evidence -
basedWork Group Considerations
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4▪80 attendees, including
–9 from tribes or tribal serving organizations
–46 from Indian Health Service (IHS)
▪Key questions and concerns raised by participants
–Will Vaxelis offer the same protection as PedvaxHIB ? 
–Need to monitor for possible breakthrough cases
–Safety and side effectsCDC/NCIRD held a listening session with tribal 
communities in January 2024
4 The use of trade names is for identification purposes only and does not imply endorsement by CDC.
Key considerations regarding post -dose 1 
immunogenicity of Vaxelis among American 
Indian and Alaska Native populations
6Study enrollment included Navajo Nation and 
Alaska Native infants
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7Anti-Hib GMC 30 days post -dose 1 was 
non-inferior after Vaxelis vs. PedvaxHIB
7 The use of trade names is for identification purposes only and does not imply endorsement by CDC.

8
GMC differences on day 151 post -dose 1 likely 
reflect the 3rd primary series dose of Vaxelis
8 The use of trade names is for identification purposes only and does not imply endorsement by CDC.
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GMC titers not available beyond day 151 to 
assess longer -term protection in this population 
9 The use of trade names is for identification purposes only and does not imply endorsement by CDC.
10▪Having a second preferred Hib vaccine option that is a combination vaccine 
may improve equity and reliability of vaccine supply
▪Immunologic data are reassuring, however
–Some concern about generalizing to broader AI/AN populations, though 
precedent for this with preferential recommendation for PedvaxHIB
–Lack of direct vaccine effectiveness data
–Study did not collect titers beyond infancy re: whether Vaxelis might 
better prevent residual cases occurring pre -booster
–Some uncertainty as to why AI/AN populations are particularly affected 
by changes in vaccination type; potentially more than just antibody 
response?Additional Work Group Considerations
10 The use of trade names is for identification purposes only and does not imply endorsement by CDC.
11▪Including Vaxelis as a second preferred option for AI/AN populations may 
improve equity and reliability of vaccine supply
▪Post -dose 1 GMCs of Vaxelis appear non -inferior to that of PedvaxHIB  
among Navajo Nation and Alaska Native populations 
▪Data gaps
–Studies in broader AI/AN populations 
–Short -term efficacy
–Longer -term immunogenicity and efficacy
▪Next steps
–GRADE/ EtR framework to be presented in June
–Plan for vote in JuneFinal reflections and next steps
11 The use of trade names is for identification purposes only and does not imply endorsement by CDC.
Acknowledgments
▪ ACIP Members on the WG
– Jamie Loehr (Interim Chair)
– Wilbur Chen
▪ Ex Officio WG Members
– Margaret Bash (FDA)
– Matthew Clark (IHS)
– Mark Connelly (FDA)
– Francisco Leyva (NIH)
▪ WG Liaisons and Consultants
– Amra Resic  (AAFP)
– Samir Shah (AAP) 
– Barb Fluty (ACHA)
– Karyn Lyons (AIM)
– Paul Cieslak (CSTE)
– Kathy Hsu (IDSA)
– Joseline Zafack (NACI)
– Jeff Goad (NFID)
– Jessica Cataldi (PIDS)
– Amy Middleman (SAHM)
– Kathy Poehling (Wake Forest)
– Lynn Bahta (Minnesota Department of Health)
– David Stephens (Emory)▪ CDC Contributors
– Lucy McNamara (DBD/NCIRD)
– Sarah Schillie (DBD/NCIRD)
– LeAnne Fox (DBD/NCIRD)
– Susan Hariri (DBD/NCIRD)
– Amy Rubis (DBD/NCIRD)
– Noele Nelson (DBD/NCIRD)
– Alison Albert (DBD/NCIRD)
– Angela Jiles (DBD/NCIRD)
– Marc Fischer (DIDRI/NCEZID)
– Jonathan Duffy (DHQP/NCEZID)
– Pedro Moro (DHQP/NCEZID)
– Tanya Myers (DHQP/NCEZID) 
– Liz Velazquez (ISD/NCIRD)
– Jessica MacNeil (ACIP Secretariat)
– Hannah Rosenblum (ACIP Secretariat)
– Melinda Wharton (ACIP Secretariat)
▪ GRADE/ EtR Support
– Doug Campos -Outcalt (Arizona)
– Rebecca Morgan (Case Western Reserve)
Thank you!
Questions?