This week’s vaccines update highlights key vaccine and immunology developments, spanning late-stage clinical trials, first-in-human programs, and global outbreak preparedness initiatives.
In Today’s Newsletter
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In Today’s Newsletter
💉 Vaxcyte starts OPUS Phase 3 for VAX-31 vs PCV21 and PCV20 [1] [US • 08 Dec 2025]
Key point: First participants dosed in ~4,000-subject noninferiority trial assessing OPA GMR vs Capvaxive (PCV21) and Prevnar 20 (PCV20) in adults 50+; topline safety, tolerability, immunogenicity targeted for Q4 2026.
Context: FDA-aligned design includes superiority testing on serotypes unique to VAX-31 (endpoint details provided). Also evaluates adults 18–49.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 First recombinant anthrax vaccine ships in Korea: BARYTHRAX inj. [2] [KR • 08 Dec 2025]
Key point: GC Biopharma shipped initial doses to KDCA for stockpiling; recombinant PA-based vaccine approved in April in Korea.
Context: Safety profile mostly mild AEs; capacity up to 10M doses per year for 4-dose regimen.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
🕷️ Korea–CEPI launch first-in-human program for SFTS mRNA vaccine [3] [KR • 09 Dec 2025]
https://www.koreabiomed.com/news/articleView.html?idxno=29904
Key point: KDCA, IVI, ST Pharm, SNU secure up to $16M from CEPI to run preclinical and Phase 1/2 in healthy adults for SFTS mRNA vaccine.
Context: SFTS is a tick-borne Phenuivirus with regional spread across East Asia; no approved vaccines.
Implication: Signals pipeline investment and modality expansion.
🧬 Scancell iSCIB1+ combo shows durable PFS signal in melanoma [4] [UK • 09 Dec 2025]
https://scancell.co.uk/wp-content/uploads/2025/12/20251209-SCOPE-data_final-PL-1.pdf
Key point: In Cohort 3 target HLA population, PFS 74% at 16 months vs reported 50% at 11.5 months for nivo–ipi alone (comparative benchmark cited in release).
Context: First-line advanced melanoma with nivolumab plus ipilimumab; ORR 56%, DCR 79% in target HLA; early OS shows 14% improvement at 26 months over standard of care.
Implication: May influence prescriber choice and payer reviews pending full data.
🦠 Oxford begins world’s first Phase II Nipah vaccine trial in Bangladesh [5] [UK • 09 Dec 2025]
https://cepi.net/university-oxford-launches-worlds-first-phase-ii-nipah-virus-vaccine-trial
Key point: ChAdOx1 NipahB Phase II to enroll 306 adults 18–55 in Bangladesh to assess safety and immunogenicity.
Context: PRIME designation granted by EMA in June 2025; vaccine uses the Oxford/AstraZeneca vector platform.
Implication: Signals pipeline investment and modality expansion.
🦴 IL-6 vaccine immunotherapy shows early benefit in knee OA [6] [09 Dec 2025]
Key point: Phase 1 double-blind study of PPV-06 was well tolerated and induced anti-IL-6 antibodies; functional improvement at week 42 in those receiving all three doses.
Context: n=24 randomized to 10 µg, 50 µg, or placebo; neutralization capacity correlated with outcomes. Phase 2 planned in 2026 across seven EU countries.
Implication: May influence prescriber choice and payer reviews pending full data.
🧊 Osivax completes enrollment for Phase 2b OVX836 influenza A trial [7] [EU • 09 Dec 2025]
https://osivax.com/ovx836-005_enrollment_completion/
Key point: 2,850 adults 18–59 enrolled in Asuniva (NCT05569239) to assess safety, immunogenicity, and efficacy of a single 480 µg dose.
Context: Trial in Belgium, France, Finland, Germany; topline expected mid-2026 subject to flu circulation. NP-targeting approach aims for broad protection.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Adult pneumococcal landscape is moving to head-to-head immunogenicity comparisons that could reset standards if superiority holds.
- Biosecurity readiness advances with a recombinant anthrax vaccine entering stockpiles.
- Prototype-pathogen work on SFTS and Nipah supports faster response to future Paramyxovirus and Phenuivirus threats.
- Cancer vaccine combinations continue to show durability signals that may inform registrational designs.
- Broad-spectrum influenza and cytokine-targeting immunotherapies diversify strategies beyond strain-matched and antibody biologics.
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FAQ
What comparators are used in Vaxcyte’s OPUS Phase 3?
VAX-31 is compared head-to-head with Capvaxive (PCV21) and Prevnar 20 (PCV20) in adults 50+, with predefined OPA GMR noninferiority and superiority criteria [1].
What is novel about GC Biopharma’s BARYTHRAX inj.?
It is the first recombinant anthrax vaccine using purified protective antigen, with annual capacity up to 10M doses for Korea’s stockpile program, showing mostly mild adverse events in studies [2].
Who is leading the SFTS mRNA effort and what is funded?
IVI leads a KDCA–IVI–ST Pharm–SNU consortium with up to $16M from CEPI to run preclinical work and Phase 1/2 testing in healthy adults in Korea [3].
What did Scancell report for iSCIB1+ in SCOPE?
In first-line advanced melanoma with nivolumab plus ipilimumab, the target HLA cohort showed 74% progression-free survival at 16 months, overall response rate 56%, and disease control rate 79%, with early overall survival trending better than standard of care at 26 months (study comparisons as cited) [4].
Where is the Nipah Phase II taking place and what platform is used?
Oxford’s ChAdOx1 NipahB trial enrolls 306 adults in Bangladesh, using the same adenoviral vector platform as the Oxford/AstraZeneca COVID-19 vaccine; EMA PRIME was granted in June 2025 [5].
What did PPV-06 show in knee osteoarthritis?
Phase 1 data indicate good tolerability and anti-IL-6 responses, with functional improvements at week 42 in fully dosed patients; a multicenter Phase 2 is planned in 2026 in seven EU countries [6].
What is Osivax testing in Asuniva and when are results expected?
A single 480 µg dose of OVX836, targeting influenza A nucleoprotein, in 2,850 adults across four EU countries; topline data is targeted for mid-2026, contingent on flu circulation [7].
Entities / Keywords
Vaxcyte; VAX-31; OPUS; Prevnar 20; Capvaxive; PCV20; PCV21; GC Biopharma; BARYTHRAX inj.; KDCA; IVI; CEPI; SFTS; mRNA vaccine; Scancell; iSCIB1+; nivolumab; ipilimumab; SCOPE; Oxford; ChAdOx1 NipahB; icddr,b; PPV-06; Peptinov; interleukin-6; osteoarthritis; Osivax; OVX836; Asuniva; nucleoprotein; oligoDOM.
References
- https://investors.vaxcyte.com/news-releases/news-release-details/vaxcyte-doses-first-participants-opus-phase-3-noninferiority
- https://www.biospace.com/press-releases/gc-biopharma-ships-first-doses-of-worlds-first-recombinant-anthrax-vaccine-barythrax-inj
- https://www.koreabiomed.com/news/articleView.html?idxno=29904
- https://scancell.co.uk/wp-content/uploads/2025/12/20251209-SCOPE-data_final-PL-1.pdf
- https://cepi.net/university-oxford-launches-worlds-first-phase-ii-nipah-virus-vaccine-trial
- https://www.medscape.com/viewarticle/il-6-vaccine-shows-early-benefit-knee-osteoarthritis-2025a1000yhv
- https://osivax.com/ovx836-005_enrollment_completion/