This vaccines update highlights key vaccine developments spanning early clinical proof-of-concept, late-stage regulatory filings, market launches, and major industry consolidation, alongside legal and access-related developments.
In Today’s Newsletter
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In Today’s Newsletter
🦟 Multistage malaria vaccine shows protection in early trial [1] [25 Dec 2025]
Key point: First-in-human Phase 1/2a of a multistage Plasmodium falciparum vaccine reported safety and protection signals in a controlled human infection model (endpoint specifics per source).
Context: Candidate targets pre-erythrocytic and blood stages; mild–moderate AEs typical of vaccine studies.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Fentanyl vaccine to begin human testing in 2026 [2] [29 Dec 2025]
https://www.livescience.com/health/a-fentanyl-vaccine-enters-human-trials-in-2026-heres-how-it-works
Key point: ARMR Sciences plans a 40-participant Phase 1 in the Netherlands in early 2026 to assess safety and antibody induction.
Context: Conjugate approach uses fentanyl hapten with CRM197 and dmLT to generate anti-fentanyl antibodies; prior efficacy shown in rats.
Implication: Signals pipeline investment and modality expansion.
🤝 Sanofi to acquire Dynavax for ~$2.2B cash [3] [29 Dec 2025]
Key point: Sanofi to buy Dynavax, adding Heplisav-B and shingles candidate Z-1018; closing targeted in Q1 2026 (per source).
Context: Deal at $15.50/share; Heplisav-B FDA-approved for adults; Z-1018 in Phase 1/2 with comparative signals vs Shingrix cited by company.
Implication: Signals pipeline investment and modality expansion.
🦠 Lassa fever vaccine rVSVΔG-LASV-GPC shows encouraging Phase 1 data [4] [29 Dec 2025]
Key point: In 114 participants (US and Liberia), single-dose vaccination induced robust IgG and T-cell responses; no vaccine-associated serious AEs or hearing loss.
Context: Dose-ranging with follow-up to 12 months; transient dose-dependent reactogenicity noted.
Implication: Signals pipeline investment and modality expansion.
🧓 RSV preF vaccines effective in older adults, meta-analysis finds [5] [30 Dec 2025]
https://www.ajmc.com/view/meta-analysis-supports-rsv-vaccine-efficacy-and-safety-in-older-adults
Key point: Systematic review of randomized trials supports reductions in RSV LRTIs and RSV-ARI in adults 60+, with no increase in serious AEs.
Context: >100,000 participants across efficacy analyses; heterogeneity addressed by excluding an outlier study.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧪 Moderna files for approval of mRNA-1010 seasonal flu vaccine [6] [05 Jan 2026]
https://feeds.issuerdirect.com/news-release.html?newsid=6583312844861441&symbol=MRNA
Key point: Marketing applications submitted to FDA, EMA, Health Canada, and Australia’s TGA for adults 50+.
Context: Based on Phase 3 data including rVE of 26.6% across adults 50+ and favorable tolerability profile (per company).
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 IAVI starts dosing in G004 Phase 1 HIV vaccine study in South Africa [7] [06 Jan 2026]
Key point: First vaccinations occurred Dec 15, 2025, launching a 96-participant dose-escalation trial of sequential mRNA immunogens to elicit bnAb precursors.
Context: IAVI/Scripps approach tests eOD-GT8 60mer, Core-g28v2 60mer, N332-GT5 gp151 on Moderna’s mRNA platform at six South African sites.
Implication: Signals pipeline investment and modality expansion.
⚖️ Bayer sues COVID-19 vaccine makers over mRNA technology patents [8] [06 Jan 2026]
Key point: Lawsuits filed alleging misuse of Monsanto-developed mRNA-stabilizing technology; defendants include Pfizer, BioNTech, Moderna, and J&J.
Context: Bayer seeks monetary damages, not injunctions; adds to ongoing COVID-19 IP litigation landscape.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
💉 Shingrix prefilled syringe approved by European Commission [9] [07 Jan 2026]
Key point: EC approved a prefilled syringe presentation of GSK’s Shingrix, maintaining indication and dosing.
Context: New format removes reconstitution step; based on technical comparability to existing presentation.
Implication: May expand screening, initiation, and follow-up at scale.
🧪 Dr. Reddy’s launches Hevaxin, recombinant Hepatitis E vaccine in India [10] [07 Jan 2026]
Key point: Hevaxin announced as DCGI-approved for active immunization against HEV in adults 18–65 in India (per source).
Context: Marketed with partners in India; source cites supportive clinical studies and WHO burden figures.
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
Why it matters
- Multistage and vector-based vaccines continue to diversify strategies against high-burden pathogens.
- Opioid crisis tools may extend beyond antagonists, with preventive immunotherapy entering the clinic.
- Big-pharma BD shifts adult vaccine portfolios and competitive shingles dynamics.
- Meta-analytic evidence supports integrating RSV vaccination into routine care for older adults.
- Regulatory momentum for mRNA flu points to faster strain-match agility and potential market reshaping.
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FAQ
What is distinct about the malaria candidate compared to RTS,S/R21?
It targets multiple parasite stages, aiming for broader protection than single-stage vaccines; early human data show safety and protection signals in a CHMI model [1].
Where and when will the fentanyl vaccine be tested first?
Phase 1 is planned in the Netherlands in early 2026 with about 40 participants, focusing on safety and antibody generation [2].
What assets drive Sanofi’s acquisition of Dynavax?
Heplisav-B, an approved adult hepatitis B vaccine, and Z-1018, an early-stage shingles candidate with comparative immune signals vs Shingrix as reported by the company [3].
What did the Lassa vaccine Phase 1 show on safety?
No vaccine-associated serious adverse events or hearing loss, with transient dose-related reactogenicity and robust IgG and T-cell responses [4].
Do RSV preF vaccines reduce clinically meaningful outcomes in older adults?
Yes, pooled randomized data support reductions in lower respiratory tract infections and RSV-associated acute respiratory illness, without an increase in serious AEs [5].
What is Moderna seeking for mRNA-1010?
Marketing authorization in the US, EU, Canada, and Australia based on Phase 3 efficacy and immunogenicity data, with a reported favorable safety profile [6].
Entities / Keywords
Multistage malaria vaccine; Plasmodium falciparum; ARMR Sciences; fentanyl vaccine; Sanofi; Dynavax; Heplisav-B; Z-1018; rVSVΔG-LASV-GPC; Lassa fever; RSV preF; Moderna; mRNA-1010; IAVI; Scripps Research; bnAbs; Bayer; Pfizer; BioNTech; Moderna; Johnson & Johnson; Shingrix; European Commission; Dr. Reddy’s; Hevaxin; DCGI; Hepatitis E.
References
[1] https://www.pharmacytimes.com/view/experimental-multistage-malaria-vaccine-demonstrates-promising-protection-in-early-trial
[2] https://www.livescience.com/health/a-fentanyl-vaccine-enters-human-trials-in-2026-heres-how-it-works
[3] https://www.fiercepharma.com/pharma/acquisitive-sanofi-keeps-deals-coming-laying-out-22b-hepatitis-vaccine-maker-dynavax
[4] https://www.medscape.com/viewarticle/lassa-fever-vaccine-shows-encouraging-results-phase-1-2025a10010j3
[5] https://www.ajmc.com/view/meta-analysis-supports-rsv-vaccine-efficacy-and-safety-in-older-adults
[6] https://feeds.issuerdirect.com/news-release.html?newsid=6583312844861441&symbol=MRNA
[7] https://www.iavi.org/press-release/iavi-announces-first-vaccinations-in-iavi-g004-a-phase-1-clinical-trial-of-a-promising-hiv-vaccine-approach/
[8] https://www.reuters.com/legal/litigation/bayer-sues-covid-vaccine-makers-over-mrna-technology-2026-01-06/
[9] https://www.investing.com/news/stock-market-news/gsks-shingrix-prefilled-syringe-receives-european-commission-approval-93CH-4434127
[10] https://www.expresspharma.in/dr-reddys-launches-hevaxin-a-novel-recombinant-hepatitis-e-vaccine-in-india/