This Vaccines video recap covers major vaccine and immunization developments, including late-stage pandemic preparedness programs, early human efficacy signals, regulatory filings, market approvals, and significant industry transactions shaping global access.

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Chapters

0:00 Introduction
0:08 CEPI–Moderna H5 pandemic influenza program funded for pivotal Phase 3, with LMIC access pledge
0:37 Multistage Plasmodium falciparum vaccine shows protection signals in early human CHMI study
0:58 ARMR fentanyl vaccine to enter first-in-human Phase 1 trial in the Netherlands in early 2026
1:29 Sanofi to acquire Dynavax for approximately 2.2 billion dollars, adding Heplisav-B and Z-1018
1:57 RSV preF vaccines demonstrate efficacy and safety in adults 60 plus, per large meta-analysis
2:24 Moderna submits marketing applications for mRNA-1010 seasonal influenza vaccine for adults 50 plus
2:51 IAVI G004 HIV vaccine begins dosing in South Africa in a 96-participant Phase 1 trial
3:29 Bayer files U.S. lawsuits over alleged misuse of mRNA-stabilizing technology, seeks damages only
3:49 European Commission approves Shingrix prefilled syringe presentation, same indication and dosing
4:10 Dr. Reddy’s announces DCGI-approved Hevaxin, a recombinant hepatitis E vaccine for adults 18–65 in India
4:35 How to reach us

Transcript

Welcome to the latest edition of Vaccines Research Updates, covering recent breakthroughs in the field. Brought to you by LucidQuest.

CEPI–Moderna H5 mRNA-1018: CEPI will invest up to 54.3 million dollars to support a pivotal Phase 3 trial of Moderna’s H5 pandemic influenza vaccine candidate, mRNA-1018. If licensed, Moderna has committed to allocate 20 percent of its H5 manufacturing capacity for timely supply to low- and middle-income countries. Trial sites are planned in the UK and the US.

Multistage malaria vaccine: An early Phase 1 slash 2a human study of a multistage Plasmodium falciparum vaccine showed encouraging safety and protection signals in a controlled human malaria infection model. The candidate targets both pre-erythrocytic and blood stages, and adverse events were described as mild to moderate.

Fentanyl vaccine, Netherlands Phase 1: ARMR Sciences will begin a roughly 40 participant Phase 1 trial in the Netherlands in early 2026 to assess safety and antibody responses of its fentanyl vaccine. The vaccine uses a fentanyl hapten conjugated to CRM197 with dmLT adjuvant, designed to block fentanyl at the blood–brain barrier. Preclinical rat data have shown supportive immune responses.

Sanofi–Dynavax acquisition: Sanofi has announced plans to acquire Dynavax for approximately 2.2 billion dollars in cash, or about 15 dollars 50 cents per share. The acquisition adds Heplisav-B, an approved adult hepatitis B vaccine, and Z-1018, an experimental shingles candidate that has shown early immune signals compared with Shingrix. The deal is expected to close in the first quarter of 2026.

RSV preF meta-analysis: A meta-analysis of randomized trials involving more than 100,000 adults aged 60 and older found that RSV preF vaccines reduced lower respiratory tract and acute respiratory infections caused by RSV, without an increase in serious adverse events. Study heterogeneity improved after exclusion of an outlier trial, strengthening the findings’ consistency.

Moderna mRNA-1010 filings: Moderna has submitted marketing applications for its mRNA-1010 seasonal influenza vaccine to the FDA, EMA, Health Canada, and the Therapeutic Goods Administration for adults aged 50 and above. The filings are based on Phase 3 data showing a relative vaccine efficacy of 26.6 percent and a favorable tolerability profile.

The first vaccinations with IAVI G004 HIV vaccine were administered on 15 December 2025 in South Africa in IAVI’s G004 Phase 1 clinical trial. The 96 participant dose-escalation study evaluates sequential mRNA immunogens designed to elicit broadly neutralizing antibody precursors. The study is conducted at six South African sites using immunogens developed by IAVI and Scripps Research, delivered via Moderna’s mRNA platform.

Bayer has filed lawsuits in Delaware and New Jersey against Pfizer, BioNTech, Moderna, and Johnson & Johnson, alleging misuse of its Monsanto-derived mRNA-stabilizing technology. The company is seeking damages but has not requested to halt vaccine manufacturing or sales.

Shingrix prefilled syringe: The European Commission has approved a prefilled syringe presentation of GSK’s Shingrix vaccine, maintaining the same indication and dosing as the existing formulation. The new presentation removes the need for reconstitution, simplifying preparation and administration for healthcare providers.

Dr. Reddy’s Hevaxin: Dr. Reddy’s Laboratories has announced the launch of Hevaxin, a recombinant hepatitis E vaccine approved by India’s Drugs Controller General for adults aged 18 to 65. The company cites supportive clinical data and WHO-reported burden figures and plans to distribute the vaccine through local partnerships to improve access in India.

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Why it matters

  • CEPI funding and mRNA platforms aim to compress timelines for pandemic influenza response.

  • Early malaria and Lassa vaccine signals broaden strategies against high-burden pathogens.

  • Preventive immunotherapy for fentanyl could add a new tool for overdose risk reduction.

  • BD moves and EU presentation updates shift competitive dynamics in shingles and hepatitis portfolios.

  • Meta-analytic evidence supports RSV vaccination in older adults, aiding guideline and payer decisions.

🗓️ Explore weekly details and sources

📚 See the full Vaccines archive on our research hub page.

FAQ

What is CEPI funding in Moderna’s H5 program and what is the access pledge?

Up to $54.3M for a pivotal Phase 3 of mRNA-1018, with Moderna committing 20% of pandemic H5 capacity for timely LMIC supply if licensed [1].

Where will the fentanyl vaccine be tested first and what does it target?

A Phase 1 in the Netherlands in early 2026, designed to induce antibodies that bind fentanyl and prevent brain entry, assessed for safety and immunogenicity [3].

What assets underpin Sanofi’s Dynavax acquisition?

Heplisav-B, an FDA-approved adult hepatitis B vaccine, and Z-1018, an early-stage shingles candidate with company-reported immune signals vs Shingrix [4].

What did IAVI G004 initiate and where?

A 96-participant Phase 1 in South Africa using sequential mRNA immunogens to steer bnAb precursor B cells against HIV [7].

What changed for Shingrix in the EU?

The EC approved a prefilled syringe presentation, maintaining indication and dosing while simplifying administration workflow [9].

What did Moderna file for mRNA-1010?

Marketing authorization in the US, EU, Canada, and Australia for adults 50+, supported by Phase 3 efficacy and tolerability data cited by the company [6].

Entities / Keywords

CEPI; Moderna; mRNA-1018; H5 influenza; multistage malaria vaccine; Plasmodium falciparum; ARMR Sciences; fentanyl vaccine; Sanofi; Dynavax; Heplisav-B; Z-1018; RSV preF; 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://feeds.issuerdirect.com/news-release.html?newsid=6130297639445566&symbol=MRNA
[2] https://www.pharmacytimes.com/view/experimental-multistage-malaria-vaccine-demonstrates-promising-protection-in-early-trial
[3] https://www.livescience.com/health/a-fentanyl-vaccine-enters-human-trials-in-2026-heres-how-it-works
[4] https://www.fiercepharma.com/pharma/acquisitive-sanofi-keeps-deals-coming-laying-out-22b-hepatitis-vaccine-maker-dynavax
[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/

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