Vaccines Video Recap—October 31, 2025

Our biweekly vaccines recap distills the most important developments, from cutting-edge science to major industry and regulatory milestones.

https://youtu.be/RH7GneOiM5Q

Top Stories Covered in This Video

💉 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 study in adults 65+, described as nearly 500k participants, two geographic areas.
Key point: Additional reductions vs standard-dose in lab-confirmed influenza hospitalizations (31.9%), pneumonia/influenza hospitalizations, cardio-respiratory hospitalizations, and all-cause hospitalizations.
Implication: May influence prescriber choice and payer reviews pending full data.

🇰🇷 Moderna update in South Korea, KDCA seasonal procurement and coadministration stance [2] [South Korea • 20 Oct 2025]

https://www.chosun.com/english/industry-en/2025/10/19/HOHWC5RXTJC5JJVTNLYQGKXDA4/
Context: KDCA secured 5.3M seasonal COVID-19 doses, including 2.02M Moderna; interview with Moderna CMO in Seoul.
Key point: Moderna underscores year-round COVID-19 circulation, supports flu COVID coadministration, and notes Phase 3 combo vaccine immune-response advantage (endpoint not specified).
Implication: May expand screening, initiation, and follow-up at scale.

🔬 VitriVax raises $17.25M Series B for thermostable single-shot platform [3] [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 grants from Gates Foundation and CEPI, plus a DoD contract.
Key point: Funds advance ALTA toward Phase 1-ready GMP to address cold-chain and multi-dose barriers (specific programs not stated).
Implication: Signals pipeline investment and modality expansion.

🧴 Shingrix prefilled syringe gets positive CHMP opinion [4] [EU • 21 Oct 2025]

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 Dec 2025.
Implication: Introduces competition that may affect pricing and formulary access.

🧒 Sanofi exits toddler RSV vaccine SP0125 after Phase 3 futility [5] [24 Oct 2025]

https://www.fiercebiotech.com/biotech/sanofi-drops-rsv-vaccine-toddlers-after-phase-3-heads-failure
Context: Intranasal live-attenuated vaccine in ~6,300 children aged 6–22 months; IDMC review.
Key point: Program terminated after IDMC judged efficacy unlikely; safety acceptable with no VAERD signal reported.
Implication: May influence prescriber choice and payer reviews pending full data.

🇸🇬 Singapore HSA approves LP.8.1-adapted monovalent COMIRNATY, 6 months+ [6] [Singapore • 24 Oct 2025]

https://finance.yahoo.com/news/pfizer-biontech-receive-health-sciences-093300910.html
Context: Variant selection aligned with FDA, EMA, WHO guidance naming LP.8.1 as preferred JN.1-lineage monovalent for fall 2025.
Key point: Approval covers individuals 6 months and older per recommendations, noted as first in Southeast Asia for this update.
Implication: Introduces competition that may affect pricing and formulary access.

👶 Moderna ends congenital CMV vaccine program after Phase 3 miss [7] [26 Oct 2025]

https://medicaldialogues.in/news/industry/pharma/moderna-scraps-mrna-vaccine-in-congenital-cmv-on-trial-failure-157472
Context: Phase 3 randomized, observer-blind, placebo-controlled trial in ~7,500 women across 13 countries.
Key point: Primary endpoint not met in seronegative women; reported VE 6–23% by case definition; safety acceptable; transplant reactivation study continues.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 EVX-01 plus pembrolizumab shows durable responses in advanced melanoma [8] [27 Oct 2025]

https://www.onclive.com/view/evx-01-plus-pembrolizumab-drives-durable-disease-control-t-cell-responses-in-advanced-melanoma
Context: Phase 2, previously untreated unresectable stage III or IV melanoma; EVX-01 is a personalized peptide-based neoantigen vaccine.
Key point: Evaluable patients (n=16) had 75% ORR, with 11 of 12 responses ongoing at 24 months; broad T-cell responses; no grade ≥3 vaccine-related AEs.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it Matters

• High-dose influenza vaccines continue to outperform standard-dose on severe outcomes in older adults [1].
• National procurement and coadministration guidance shape seasonal COVID-19 strategies in Asia [2][6].
• Platform and presentation innovations target access and ease of use, from thermostable single-shot formulations to prefilled syringes [3][4].
• Pediatric RSV strategies shift as a toddler vaccine is halted, keeping antibodies central for now [5].
• Oncology vaccines show durable activity signals that could inform future combinations and personalization approaches [8].

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FAQ

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

Sanofi reports additional reductions vs standard-dose in lab-confirmed influenza hospitalizations, pneumonia or influenza hospitalizations, cardio-respiratory hospitalizations, and all-cause hospitalizations in adults 65+ [1].

How many Moderna doses did KDCA secure for 2025–2026?

KDCA procured 5.3M seasonal COVID-19 doses in total, including 2.02M Moderna doses; authorities support flu COVID coadministration [2].

What is new about Shingrix in the EU?

CHMP issued a positive opinion for a prefilled syringe presentation intended to simplify administration; EC decision expected in Dec 2025 [4].

Which COVID-19 update did Singapore approve?

Pfizer/BioNTech’s LP.8.1-adapted monovalent COMIRNATY for individuals 6 months and older, aligned with FDA, EMA, and WHO guidance on LP.8.1 selection [6].

Why did Sanofi stop its toddler RSV vaccine?

An IDMC indicated Phase 3 futility for SP0125 on efficacy; Sanofi ended the program with safety described as acceptable and no VAERD signal [5].

What happened in Moderna’s congenital CMV trial?

mRNA-1647 did not meet the primary endpoint in seronegative women, with VE reported at 6–23% depending on definition; the congenital program is discontinued while a transplant study continues [7].

Entities / Keywords

Sanofi; Efluelda; Fluzone High-Dose; FLUNITY-HD • KDCA; Moderna; Spikevax • VitriVax; ALTA platform • GSK; Shingrix; CHMP • Sanofi; SP0125; Beyfortus • Pfizer; BioNTech; COMIRNATY; LP.8.1 • Moderna; mRNA-1647; CMV • Evaxion; EVX-01; pembrolizumab; Keytruda.

References