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.
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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.
References
- https://www.fiercebiotech.com/biotech/sanofi-drops-rsv-vaccine-toddlers-after-phase-3-heads-failure
- https://finance.yahoo.com/news/pfizer-biontech-receive-health-sciences-093300910.html
- https://medicaldialogues.in/news/industry/pharma/moderna-scraps-mrna-vaccine-in-congenital-cmv-on-trial-failure-157472
- https://www.onclive.com/view/evx-01-plus-pembrolizumab-drives-durable-disease-control-t-cell-responses-in-advanced-melanoma
- https://www.expresspharma.in/cepi-university-of-oxford-and-serum-institute-to-establish-investigational-nipah-virus-vaccine-reserve/