Vaccines Today—October 24, 2025

LucidQuest

2 weeks ago

This week’s vaccine news delivers the latest updates, research developments, and progress from leading biopharma companies.

In Today’s Newsletter

💉 Sanofi high-dose flu vaccine superior to standard-dose on severe outcomes [1] [EU • 20 Oct 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-20-05-00-00-3169062
Context: FLUNITY-HD, individually randomized, multi-season trial in adults 65+ (described as nearly 500k participants).
Key point: Efluelda/Fluzone High-Dose reduced lab-confirmed flu hospitalizations and was superior on pneumonia/influenza, cardio-respiratory, and all-cause hospitalizations.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Enhanced flu vaccines for older adults, ESWI data and Nordic modeling, CSL Seqirus [2] [21 Oct 2025]

https://newsroom.csl.com/2025-10-21-Enhanced-Influenza-Vaccines-Provide-Essential-Protection-for-Older-Adults-CSL-Seqirus-Presents-New-Evidence-Supporting-Broader-Adoption-Across-Europe
Context: ESWI Valencia presentations, Nordic policy modeling, US test-negative study in adults 65+.
Key point: aQIV and HD-QIV showed comparable effectiveness in 65+, with both previously outperforming standard-dose; modeling suggests broader 65+ use cuts healthcare burden.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 Cell-based QIV vs egg-based QIV RWE, US 2023/24, CSL Seqirus [3] [US • 21 Oct 2025]

https://finance.yahoo.com/news/recent-rwe-data-show-cell-123000008.html
Context: Retrospective test-negative RWE using linked EHR, claims, and lab data; n=106,779, ages 6 months–64 years.
Key point: Cell-based QIV had 19.8% rVE vs standard egg-based QIV against test-confirmed influenza, consistent across pediatric, adult, outpatient, and high-risk subgroups.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🫁 American Lung Association launches vaccination education campaign [4] [US • 22 Oct 2025]

https://finance.yahoo.com/news/american-lung-association-launches-campaign-100400791.html
Context: Targets 35M with chronic lung disease and 235k new lung cancer diagnoses annually; references 2024–2025 high-severity season.
Key point: Promotes flu, COVID-19, RSV vaccination, plus a new lung-cancer vaccine resource and a webinar.
Implication: May expand screening, initiation, and follow-up at scale.

🇰🇷 Moderna update in South Korea, KDCA procurement for 2025–2026 [5] [South Korea • 20 Oct 2025]

https://www.chosun.com/english/industry-en/2025/10/19/HOHWC5RXTJC5JJVTNLYQGKXDA4/
Context: Interview with Moderna CMO; KDCA secured 5.3M seasonal COVID-19 doses, including 2.02M Moderna.
Key point: Moderna underscores year-round COVID-19 circulation, supports flu COVID coadministration, and notes progress on combo vaccine in phase 3.
Implication: May expand screening, initiation, and follow-up at scale.

🧬 IO Biotech phase 3 melanoma combo narrowly misses PFS significance [6] [20 Oct 2025]

https://www.ajmc.com/view/after-narrow-miss-in-phase-3-study-io-biotech-ponders-next-steps-for-immune-modulatory-off-the-shelf-cancer-vaccine
Context: First-line advanced melanoma, Cylembio plus pembrolizumab; ESMO Berlin presentation.
Key point: mPFS 19.4 vs 11.0 months, HR 0.77, P=0.0558; stronger effect in PD-L1–negative tumors; safety similar to pembrolizumab alone.
Implication: May influence prescriber choice and payer reviews pending full data.

🧷 BioNTech pauses BNT111 in late-stage refractory melanoma [7] [20 Oct 2025]

https://www.fiercebiotech.com/biotech/biontech-fades-out-further-work-fixvac-vaccine-prospect-advanced-melanoma-setting
Context: Phase 2 combo with Regeneron’s Libtayo in PD-(L)1-relapsed/refractory melanoma.
Key point: Despite an ORR signal and survival data, BioNTech will not proceed in this setting, shifting FixVac focus to BNT116 and BNT113.
Implication: Signals pipeline investment and modality expansion.

🧴 Shingrix prefilled syringe receives positive CHMP opinion [8]

https://www.gsk.com/en-gb/media/press-releases/gsk-s-shingrix-new-prefilled-syringe-presentation-receives-positive-chmp-opinion/
Context: Current EU presentation requires two-vial reconstitution; positive opinion based on technical comparability.
Key point: Prefilled syringe aims to simplify administration for healthcare professionals; EC decision expected December 2025.
Implication: Introduces competition that may affect pricing and formulary access.

🔬 VitriVax raises $17.25M Series B for thermostable single-shot platform [9] [US • 23 Oct 2025]

https://www.biospace.com/press-releases/vitrivax-raises-17-25-million-series-b-financing-to-advance-vaccine-formulation-platform
Context: Financing co-led by Adjuvant Capital and RA Capital; prior Gates Foundation grant, CEPI support, DoD contract.
Key point: Funds advance ALTA toward Phase 1-ready GMP to address cold-chain and multi-dose barriers.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

Enhanced and high-dose influenza vaccines continue to show advantages over standard-dose in older adults [1][2].
Cell-based manufacturing may yield improved effectiveness vs egg-based comparators in younger populations [3].
Public-health campaigns and government procurement target uptake and seasonal readiness in high-risk groups [4][5].
Oncology vaccine strategies are being recalibrated after mixed late-stage outcomes [6][7].
Administration and formulation innovations could simplify vaccination at scale [8][9].

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FAQ

What did FLUNITY-HD show for Sanofi’s high-dose flu vaccine?

Sanofi reports superiority vs standard-dose across lab-confirmed influenza hospitalizations, pneumonia/influenza, cardio-respiratory events, and all-cause hospitalizations in adults 65+ [1].

Are adjuvanted and high-dose flu vaccines comparable in older adults?

CSL Seqirus cites RWE indicating similar effectiveness between aQIV and HD-QIV in adults 65+, with both previously outperforming standard-dose [2].

Do cell-based flu vaccines outperform egg-based for younger groups?

In 2023/24 US RWE, cell-based QIV showed 19.8% rVE vs standard egg-based QIV in ages 6 months–64 years; observational limits apply [3].

What is the ALA campaign offering this season?

ALA is promoting flu, COVID-19, and RSV vaccination for people with lung disease and lung cancer, adding a new resource and a webinar [4].

How will Shingrix’s prefilled syringe affect practice in the EU?

If approved, it removes reconstitution steps, easing administration for healthcare professionals; EC decision expected December 2025 [8].

Entities / Keywords

Sanofi; Efluelda; Fluzone High-Dose; FLUNITY-HD • CSL Seqirus; aQIV; HD-QIV; QIVc; QIVe; ESWI • American Lung Association • KDCA; Moderna; Spikevax • IO Biotech; Cylembio; pembrolizumab • BioNTech; BNT111; Libtayo; FixVac; BNT116; BNT113 • GSK; Shingrix; CHMP • VitriVax; ALTA platform; thermostable vaccines.