Vaccines Today—February 6, 2026

This week’s Vaccines update covers regulatory actions, Phase 1–3 clinical progress, a large-scale real-world pilot program, and comparative trial design updates across infectious disease and oncology.

In Today’s Newsletter

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🧪 Arcturus completes Phase 1 for sa-mRNA influenza vaccine ARCT-2304 [1] [01 Feb 2026]

https://www.ad-hoc-news.de/boerse/news/ueberblick/arcturus-therapeutics-reaches-key-clinical-trial-milestone/68540921
Context: Program compares dose levels vs licensed influenza vaccines and is supported by BARDA (n not stated, duration not stated).
Key point: Phase 1 first-in-human study of ARCT-2304 completed, assessing safety and tolerability of sa-mRNA influenza vaccine (endpoint not specified).
Implication: May influence prescriber choice and payer reviews pending full data.

🧿 TuHURA’s IFx-2.0 gets FDA ODD in cutaneous melanoma [2] [US • 02 Feb 2026]

https://www.cancernetwork.com/view/novel-cancer-vaccine-receives-fda-orphan-drug-designation-in-cutaneous-melanoma
Context: Early Phase 1 showed safety with no DLTs; company also running a Phase 3 in MCC with pembrolizumab (endpoint not specified here).
Key point: FDA grants orphan drug designation for IFx-2.0 in stage IIB–IV cutaneous melanoma.
Implication: Introduces competition that may affect pricing and formulary access.

🧠 Australia launches personalized mRNA trial for pediatric brain tumors [3] [Australia • 03 Feb 2026]

https://www.9news.com.au/national/brain-tumour-vaccine-trial-for-children-in-australia/0c929d47-a04b-476a-8da2-e0615483b0fd
Context: Four-year study at eight hospitals, ~70 children; Phase 1 to determine dose, Phase 2 to assess efficacy and QoL (numbers approximate as reported).
Key point: Nationwide trial to deliver individualized mRNA vaccines to children with aggressive brain tumors.
Implication: May influence prescriber choice and payer reviews pending full data.

🦟 Valneva and Instituto Butantan start Brazil pilot with IXCHIQ [4] [Brazil • 03 Feb 2026]

https://www.manilatimes.net/2026/02/03/tmt-newswire/globenewswire/valneva-and-instituto-butantan-announce-initiation-of-a-pilot-vaccinationcampaignin-brazil-with-single-shot-chikungunya-vaccine-ixchiq/2270294/amp
Context: Goal 20–40 percent coverage; up to 500,000 doses donated via Instituto Butantan; ANVISA approval in Apr 2025.
Key point: Pilot vaccination strategy begins in 10 municipalities using single-shot IXCHIQ for adults 18–59.
Implication: May expand screening, initiation, and follow-up at scale.

🦠 University of Tokyo Nipah vaccine to enter Phase 1 in Belgium [5] [Belgium • 04 Feb 2026]

https://www.business-standard.com/health/human-trials-for-japan-developed-nipah-vaccine-set-to-begin-in-april-126020400276_1.html
Context: Trial to enroll 60 healthy adults with European Vaccine Initiative; supportive animal data reported (hamsters).
Key point: Recombinant measles-vector Nipah candidate to start Phase 1 in April, focusing on safety and immunogenicity.
Implication: May influence prescriber choice and payer reviews pending full data.

🧴 Invivyd aligns with FDA on LIBERTY Phase 3 design for VYD2311 [6] [US • 04 Feb 2026]

https://www.clinicaltrialsarena.com/news/invivyd-fda-advice-liberty-trial/
Context: ~210 participants; DECLARATION BLA-enabling trial continues in parallel with 1,770 participants and mid-2026 topline target.
Key point: LIBERTY will compare VYD2311 to mRNA COVID vaccines and evaluate co-administration; myocarditis/pericarditis monitoring requested by FDA.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

sa-mRNA and vector platforms continue to diversify vaccine modalities across infectious disease and oncology.
Real-world pilots like IXCHIQ in Brazil can generate effectiveness data that regulators and payers value.
Pediatric personalized oncology vaccines are moving from concept to coordinated multi-site trials.
FDA design input on comparative trials, including safety surveillance, can shape adoption pathways for antibody prophylaxis.

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FAQ

What did Arcturus actually complete for ARCT-2304?

A first-in-human Phase 1 safety and tolerability study for an sa-mRNA influenza vaccine, with dose comparisons vs licensed flu vaccines [1].

What does FDA orphan drug designation mean for IFx-2.0?

It provides incentives for development in stage IIB–IV cutaneous melanoma, reflecting unmet need; efficacy endpoints were not specified in the source summary [2].

How big is Australia’s pediatric brain tumor vaccine trial?

Approximately 70 children over four years at eight hospitals, starting with dose-finding then efficacy and QoL assessments [3].

What is Brazil’s IXCHIQ pilot aiming to show?

Real-world effectiveness and safety in adults 18–59, targeting 20–40 percent coverage in selected municipalities with up to 500,000 donated doses [4].

Where and when will the Nipah vaccine be tested?

Phase 1 is slated for Belgium in April, enrolling 60 healthy adults using a measles-vector platform developed by the University of Tokyo [5].

How will Invivyd’s LIBERTY trial differ from DECLARATION?

LIBERTY compares VYD2311 with mRNA vaccines and co-administration, with myocarditis monitoring; DECLARATION is placebo-controlled and BLA-enabling for prevention efficacy [6].

Entities / Keywords

Arcturus Therapeutics; ARCT-2304; sa-mRNA; BARDA; TuHURA Biosciences; IFx-2.0; FDA orphan drug designation; Cutaneous melanoma; Australia pediatric brain tumors; Personalized mRNA; Valneva; Instituto Butantan; IXCHIQ; Chikungunya; ANVISA; University of Tokyo; Nipah virus; Measles-vector vaccine; European Vaccine Initiative; Invivyd; VYD2311; LIBERTY trial; DECLARATION trial; mRNA COVID vaccines.