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1 Breakthroughs that change patients’ lives Monovalent XBB.1.5 BNT162b2 COVID-19 Vaccine
ACIP Presentation September 12, 2023
CC-2Presentation Outline
Kayvon Modjarrad, M.D., Ph.D.
Executive Director, Viral Vaccines
Vaccine Research and Development, Pfizer Inc. Variant Epidemiology
COVID-19 Updated Vaccine
Approval Pathway
Monovalent XBB.1.5 BNT162b2
Vaccine Activity Against
Contemporary Omicron Sublineages
Clinical Update
CC-3XBB Sublineages Continue to Dominate the Epidemiolo gic
Landscape, Despite the Emergence of New Lineages
Growing Dominance of EG.5.1
Source: 3D Spike Model - Pfizer
Mutation Prediction - jbloomlab.github.io/SARS2-RBD-escape-calc Source: GISAID - gisaid.org , data accessed/analyzed in Pizer, September 08, 20 23
BA.2.86 has high mutational density in Spike
protein but accounts for <1% of cases
CC-4Pathway for COVID-19 Variant-Adapted Vaccine Update s
COVID-19
Vaccine
Development Early-stage development
“at risk” and
surveillance to inform
variant selection Manufacture (pre-clinical
and CMC data), Regulatory
Submissions and Review Distribute Vaccines Strain Selection FDA Authorization/Approval
ACIP Recommendation
• In accordance with FDA guidance for licensure, pre clinical/CMC
data package submission and review help ensure time ly
availability of seasonal variant-matched vaccine, s imilar to the
model for annual influenza vaccine updates.
CC-5Clinical and Preclinical Experience with Variant-mo dified Vaccines –
Supported Bivalent BA.4/5 Vaccine Authorization
Preclinical Data Clinical Data Vaccine Regimen Age Group Modified Vaccine Beta monovalent Omicron BA.1 monovalent Omicron BA.1 bivalent Omicron BA.4/5 bivalent
Ongoing Single Dose 12 to 55 years
>55 years Omicron XBB.1.5 monovalent
18 to 55 years
18 to 55 years
18 to 55 years
>55 years
6 months to 11 years
12 to 55 years
>55 years
Original Vaccine
Variant Vaccine
CC-6Booster Vaccination Study Design
Female Balb/c mice (10 per group) were experienced with a primary series of monovalent BNT162b2 Origin al vaccine and a 3 rd booster dose of
bivalent BNT162b2 (Original+BA.4/5) vaccine. Mice t hen received a 4 th booster dose of either a bivalent BNT162b2 (Origina l+BA.4/5) or a monovalent
BNT162b2 (XBB.1.5) vaccine.
Data were generated by same pseudovirus neutralizat ion assay and from sera of same mouse study present ed at VRBPAC June 15, 2023 meeting
(https://www.fda.gov/media/169541/download ).
Data on file: Pfizer-BioNTech. September 2023. Blood sample
Vaccination
0 21 105 134 Day: 160
Monovalent
Original Monovalent
Original Bivalent
Original+BA.4/5 Bivalent
Original+BA.4/5
Monovalent
XBB.1.5
CC-7Monovalent XBB.1.5 BNT162b2 Booster Vaccine Effectiv ely Neutralized
Predominant and Emerging Variants
Data were generated by the same pseudovirus neutral ization assay and from sera of same mouse study tha t generated data that were presented at VRBPAC June 15, 2023 Meeting ( https://www.fda.gov/media/169541/download ).
50% Neutralization Titers are Geometric Mean Titers of 10 mice per vaccine group. LOD, limit of detect ion; the lowest serum dilution of 1:20.
CC-8Monovalent XBB.1.5 BNT162b2 Booster Vaccine Elicite d Substantially Higher
Neutralizing Response Compared to the Bivalent Vacc ine
Data were generated by same pseudovirus neutralizat ion assay and from sera of same mouse study that ge nerated data that were presented at VRBPAC June 15, 2023 Meeting ( https://www.fda.gov/media/169541/download ).
GMR = Geometric Mean Ratio of the Geometric Mean Ti ter (GMT) of Monovalent XBB.1.5 divided by GMT of W T+BA.4/5 group. LOD, limit of detection; the lowes t serum dilution of 1:20.
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CC-9Blood sample
Vaccination
0 21 49 Day:
Bivalent
(Original/BA.4/5)
Monovalent
XBB.1.5
Bivalent
(Original/BA.4/5)
Monovalent
XBB.1.5 Primary Series Study Design
Female Balb/c mice (10 per group) were administered 2 doses (21 days apart) of either bivalent BNT162b 2 (Original+BA.4/5) or monovalent
BNT162b2 (XBB.1.5) vaccine.
Data were generated by same pseudovirus neutralizat ion assay and from sera of same mouse study present ed at VRBPAC June 15, 2023 meeting
(https://www.fda.gov/media/169541/download ).
Data on file: Pfizer-BioNTech. September 2023.
CC-10These data were generated by same pseudovirus neutr alization assay and from sera of same mouse study t hat generated data that were presented at VRBPAC Jun e 15, 2023 Meeting ( https://www.fda.gov/media/169541/download ).
50% Neutralization Titers are Geometric Mean Titers of 10 mice per vaccine group.
LOD, limit of detection; the lowest serum dilution of 1:20. Monovalent XBB.1.5 BNT162b2 Primary Series Effectiv ely Neutralized
EG.5.1 and XBB.1.5
CC-11Monovalent XBB.1.5 BNT162b2 Primary Series Elicited Substantially Higher
Neutralizing Response Compared to the Bivalent Vacc ine
These data were generated by same pseudovirus neutr alization assay and from sera of same mouse study t hat generated data that were presented at VRBPAC Jun e 15, 2023 Meeting ( https://www.fda.gov/media/169541/download ).
GMR = Geometric Mean Ratio of the Geometric Mean Ti ter (GMT) of Monovalent XBB.1.5 and Bivalent XBB.1. 5+BA.4/5 divided by GMT of WT+BA.4/5 group.
LOD, limit of detection; the lowest serum dilution of 1:20.
CC-12Monovalent XBB.1.5 BNT162b2 Clinical Study in Individuals ≥ 12 years
Monovalent XBB.1.5 BNT162b2 30µg
Group 1 (n=200): 12- 55 years
Group 2 (n=200): >55 years
CC-13• The SARS-CoV-2 epidemiologic landscape remains dom inated by XBB
sublineages.
• Monovalent XBB.1.5 BNT162b2 is equally immunogenic against XBB.1.5,
EG.5.1 and BA.2.86, in a COVID-19 vaccine-experienc ed preclinical study.
• Variant-adapted vaccines improve immune responses against antigenically
matched and closely related strains.
• A preclinical/CMC package for variant-adapted COVI D-19 vaccine fulfilled
licensure criteria. Summary
14 Breakthroughs that change patients’ lives Monovalent XBB.1.5 Pfizer-BioNTech COVID-19 Vaccine
ACIP September 12, 2023