Vaccines Today—November 28, 2025

This week’s vaccine report covers major developments, pipeline progress, and updates from leading biopharma companies.

In Today’s Newsletter

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🌬️ Indonesia begins Phase 1 for inhaled TB vaccine [1] [ID • 23 Nov 2025]

https://observerid.com/indonesia-launches-phase-1-trial-for-worlds-first-inhaled-tb-vaccine/

Context: Single-site recruitment with 36 adults, two dose groups, follow-up to day 180; collaboration includes FKUI, Persahabatan Hospital, Etana, and CanSino.

Key point: First-in-human evaluation of an inhaled TB vaccine to assess safety and immunogenicity in adults 18–49 (endpoint not specified).

Implication: Signals pipeline investment and modality expansion.

🛡️ Cidara hits 6,000 enrollment in Phase 3 ANCHOR for CD388 flu prevention [2] [US/UK • 24 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/24/3193451/0/en/Cidara-Therapeutics-Reaches-Target-Enrollment-of-Phase-3-ANCHOR-Trial-Evaluating-CD388-for-Prevention-of-Seasonal-Influenza-in-High-Risk-Populations.html

Context: Randomized, double-blind, placebo-controlled trial testing single 450 mg SC dose in high-risk adults and adolescents; interim analysis planned Q1 2026.

Key point: Target enrollment reached for non-vaccine influenza preventative CD388; single Phase 3 intended to support BLA if successful.

Implication: Signals pipeline investment and modality expansion.

🧬 Everest Medicines doses first patient with EVM14 mRNA TAA vaccine [3] [US/China • 24 Nov 2025]

https://www.clinicaltrialsarena.com/news/everest-trial-evm14-vaccine/

Context: Phase 1 dose-escalation in sq-NSCLC and HNSCC, monotherapy and with PD-1, across US and China centers.

Key point: First patient dosed to assess safety and early activity in heavily pretreated squamous cancers (n not stated).

Implication: Signals pipeline investment and modality expansion.

👶 Blue Lake can resume enrolling RSV-negative toddlers for BLB201 [4] [US • 24 Nov 2025]

https://www.biospace.com/press-releases/blue-lake-biotechnology-to-resume-enrollment-of-rsv-negative-toddlers-in-phase-1-2a-clinical-trial-of-blb201

Context: FDA lifted partial clinical hold following Type C meeting; prior preliminary analysis suggested reduced symptomatic RSV vs placebo.

Key point: Enrollment cleared for children as young as 18 months regardless of serostatus in ongoing Phase 1/2a.

Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.

🧪 Experimental vaccine shows early promise in fibrolamellar carcinoma [5] [US • 24 Nov 2025]

https://medicalxpress.com/news/2025-11-experimental-liver-cancer-vaccine-young.html

Context: Phase 1 at Johns Hopkins and St. Jude; report notes disease control in most patients and deep responses in a subset.

Key point: Early trial indicates safety and immune activity, with some notable responses in pediatric and young adult FLC (endpoint specifics not detailed).

Implication: May influence prescriber choice and payer reviews pending full data.

🪲 Gavi–UNICEF deal to expand access to R21/Matrix-M malaria vaccine [6] [24 Nov 2025]

https://www.thehindu.com/sci-tech/health/gavi-unicef-announce-new-agreement-to-make-r21matrix-m-malaria-vaccines-more-accessible/article70317510.ece/

Context: Agreement targets $2.99 per dose within about a year, up to $90M savings enabling 30M more doses over five years.

Key point: Pricing and procurement move expected to fully vaccinate nearly 7M additional children, complementing RTS,S.

Implication: Access programs: May expand screening, initiation, and follow-up at scale.

🕷️ Valneva VLA15 Lyme vaccine posts positive final Phase 2 results [7] [FR • 26 Nov 2025]

https://valneva.com/wp-content/uploads/2025/11/2025_11_26_VLA15_221_Phase-2_Results-1.pdf

Context: VLA15-221 randomized, observer-blind Phase 2 across adults and children 5–17; yearly boosters at months 18, 30, 42.

Key point: Strong anamnestic responses six months after third yearly booster, across six serotypes and ages, with no DMC safety concerns.

Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

• Inhaled TB vaccine could shift delivery paradigms in high-burden settings if later-phase data support efficacy.
• Non-vaccine flu prevention and intranasal RSV approaches broaden respiratory disease toolkits beyond classic vaccines.
• mRNA and TAA cancer vaccines continue to probe hard-to-treat solid tumors where options are limited.
• Lower R21/Matrix-M pricing supports scale-up in endemic regions and complements existing malaria tools.
• Durable Lyme immunogenicity supports seasonal booster strategy as Phase 3 completes vaccinations.

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FAQ

What is Indonesia testing in its TB study, and who is involved?

A Phase 1 inhaled TB vaccine assessing safety and immunogenicity in adults, led by FKUI’s Prof. Erlina Burhan with Persahabatan Hospital, Etana, and CanSino participation [1].

What does Cidara’s ANCHOR enrollment milestone mean for CD388?

The Phase 3 trial reached 6,000 participants and will run an interim analysis in early 2026. If successful, results from this single study may support a BLA in high-risk populations [2].

Which cancers is Everest’s EVM14 targeting in Phase 1?

EVM14, an off-the-shelf mRNA TAA vaccine, is enrolling advanced sq-NSCLC and HNSCC patients as monotherapy and with a PD-1 antibody to assess safety and preliminary efficacy [3].

What changed for Blue Lake’s pediatric RSV trial?

FDA lifted a partial clinical hold, allowing enrollment of toddlers from 18 months regardless of RSV serostatus in the BLB201 Phase 1/2a study [4].

What did the fibrolamellar carcinoma vaccine report show?

An early Phase 1 report noted disease control in most participants and deep responses in a subset, including pediatric cases, with details limited in the summary [5].

How will the R21/Matrix-M agreement affect access?

Gavi–UNICEF’s deal sets a $2.99 price per dose in about a year, enabling over 30 million additional doses and nearly 7 million more fully vaccinated children over five years [6].

What do the latest VLA15 data suggest about Lyme vaccination strategy?

Phase 2 results show robust anamnestic responses across serotypes and ages after yearly boosters, supporting a seasonal vaccination approach as Phase 3 proceeds [7].

Entities / Keywords

Indonesia inhaled TB vaccine; Etana; CanSino; Cidara Therapeutics; CD388; ANCHOR; Everest Medicines; EVM14; PIV5-vectored RSV vaccine; Blue Lake Biotechnology; BLB201; fibrolamellar carcinoma; Johns Hopkins; St. Jude; R21/Matrix-M; Gavi; UNICEF; Serum Institute of India; Novavax Matrix-M; RTS,S/AS01; Valneva; VLA15; Lyme disease.

References