Vaccines Today—October 31, 2025

Stay informed with this week’s vaccine updates, highlighting clinical developments, innovations, and biopharma progress in the space.

In Today’s Newsletter

🧒 Sanofi exits toddler RSV vaccine SP0125 after Phase 3 futility [1] [24 Oct 2025]

https://www.fiercebiotech.com/biotech/sanofi-drops-rsv-vaccine-toddlers-after-phase-3-heads-failure
Context: Intranasal live-attenuated RSV vaccine in ~6,300 children aged 6–22 months; Phase 3 launched in 2024 with planned completion in 2027.
Key point: IDMC judged SP0125 unlikely to demonstrate suitable efficacy; Sanofi terminated the program. Safety acceptable, no VAERD signals reported.
Implication: May influence prescriber choice and payer reviews pending full data.

🇸🇬 Pfizer/BioNTech win HSA nod for LP.8.1-adapted COMIRNATY, 6 months+ [2] [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: Singapore approved the LP.8.1-adapted monovalent COVID-19 vaccine, first in Southeast Asia per release. Indicated from 6 months of age, per recommendations.
Implication: Introduces competition that may affect pricing and formulary access.

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

https://medicaldialogues.in/news/industry/pharma/moderna-scraps-mrna-vaccine-in-congenital-cmv-on-trial-failure-157472
Context: Randomized, observer-blind, placebo-controlled Phase 3, ~7,500 women across 13 countries; VE ranged 6–23% depending on case definition; safety acceptable. Ongoing Phase 2 in transplant reactivation continues.
Key point: mRNA-1647 failed to meet primary efficacy endpoint in seronegative women of childbearing age; congenital CMV development discontinued.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 EVX-01 plus pembrolizumab shows 75% ORR with durable responses in melanoma [4] [27 Oct 2025]

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

🦠 CEPI–Oxford–Serum Institute to build investigational Nipah vaccine reserve [5] [29 Oct 2025]

https://www.expresspharma.in/cepi-university-of-oxford-and-serum-institute-to-establish-investigational-nipah-virus-vaccine-reserve/
Context: CEPI funding up to US$7.3M for SII process development and manufacturing; platform is the Oxford ChAdOx1 vector used in COVID-19 vaccine; no approved Nipah countermeasures.
Key point: Up to 100,000 doses of ChAdOx1 NipahB to support a Phase II trial in a Nipah-affected country and potential emergency outbreak use.
Implication: Signals pipeline investment and modality expansion.

Why it Matters

RSV pediatric landscape shifts as Sanofi halts a toddler vaccine program while antibodies remain central.
Singapore’s LP.8.1 approval sets a regional benchmark for updated COVID-19 vaccines.
CMV setback highlights difficulty of preventing primary infection despite large trials and mRNA platforms.
Personalized cancer vaccines continue to show immunogenicity and durable activity signals in early–mid stage studies.
Nipah preparedness advances with a concrete stock of investigational doses tied to mid-stage trials.

🚀 Accelerate your success. Contact us now

📂 Explore our case studies. See examples of our work.

💡 Read our insights. Learn from our latest reports and analysis

🎬 Watch on YouTube. Subscribe and never miss a video.

🧰 See our full range of services. Discover how we can help you.

FAQ

What exactly did Sanofi discontinue in RSV?

Sanofi ended development of SP0125, an intranasal live-attenuated RSV vaccine for children 6–22 months, after Phase 3 futility guidance from the IDMC; safety was acceptable with no VAERD signal [1].

Which COVID-19 vaccine variant did Singapore approve?

Pfizer/BioNTech’s LP.8.1-adapted monovalent COMIRNATY for individuals 6 months and older, aligning with FDA, EMA, and WHO guidance on LP.8.1 selection for fall 2025 [2].

What happened in Moderna’s congenital CMV Phase 3?

mRNA-1647 did not meet the primary endpoint of preventing CMV infection in seronegative women; VE was 6–23% depending on definition. Moderna discontinued congenital CMV development but continues a Phase 2 in transplant settings [3].

How strong is the EVX-01 plus pembrolizumab signal?

In a Phase 2 with evaluable n=16, ORR was 75%, with durable responses at 24 months and broad T-cell responses; vaccine-related grade ≥3 AEs were not reported [4].

What is being created for Nipah readiness?

CEPI, Oxford, and Serum Institute will produce up to 100,000 ChAdOx1 NipahB doses for a Phase II trial and possible emergency deployment, supported by up to US$7.3M in CEPI funding [5].

Entities / Keywords

Sanofi; SP0125; Beyfortus • Pfizer; BioNTech; COMIRNATY; LP.8.1 • Moderna; mRNA-1647; CMV • Evaxion; EVX-01; pembrolizumab; Keytruda; melanoma • CEPI; University of Oxford; Serum Institute of India; ChAdOx1 NipahB; Nipah virus.