Vaccines Today—February 13, 2026

This weekly update in vaccines research covers regulatory actions, early- and mid-stage clinical progress, data readouts, manufacturing partnerships, and corporate transactions across multiple regions.

In Today’s Newsletter

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🧪 NeoVac next-gen mRNA–LNP shows first-in-human safety signal [1] [06 Feb 2026]

https://www.biopharminternational.com/view/first-in-human-study-validates-safety-of-next-generation-mrna-lnp-platform
Context: Data posted as Lancet preprint; company positions platform for vaccines and therapeutics.
Key point: Phase I/II first-in-human COVID-19 vaccine study reported favorable safety and biological activity vs authorized mRNA vaccines (endpoint specifics not detailed in source summary).
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Delonix DX-104 MenB OMV vaccine clears IND in China, CTN in Australia [2] [China/Australia • 06 Feb 2026]

https://finance.yahoo.com/news/delonix-bioworks-announces-ind-clearance-120000799.html
Context: DX-104 uses engineered OMV Plus platform, reports robust preclinical SBA responses and commercial-scale production.
Key point: IND cleared by NMPA in China; Australian CTN and ethics approval completed, Phase I to evaluate safety and immunogenicity.
Implication: Signals pipeline investment and modality expansion.

🦠 India begins Phase I for improved Kyasanur Forest Disease vaccine [3] [India • 08 Feb 2026]

https://www.thehindu.com/sci-tech/health/icmr-initiates-human-clinical-trials-for-improved-kyasanur-forest-disease-vaccine/article70606917.ece
Context: Animal challenge and toxicity completed; GLP-grade material manufactured; further trials planned if Phase I is successful.
Key point: ICMR initiates Phase I trial of fully indigenous two-dose inactivated KFD vaccine developed with IIL.
Implication: May expand screening, initiation, and follow-up at scale.

🫁 GSK Arexvy filing accepted for review in China, adults 60+ [4] [China • 10 Feb 2026]

https://www.jamessharp.co.uk/market-news/china-cde-accepts-arexvy-adults-60-application/
Context: Submission includes Phase III immuno-bridging study in China meeting all primary endpoints; vaccine approved for older adults in many countries.
Key point: China CDE accepts Arexvy application for RSV-LRTD in adults 60+, with decision expected in 2027.
Implication: Introduces competition that may affect pricing and formulary access.

🧾 Sanofi completes acquisition of Dynavax, adds HEPLISAV-B and Z-1018 [5] [10 Feb 2026]

https://www.manilatimes.net/2026/02/10/tmt-newswire/globenewswire/press-release-sanofi-completes-the-acquisition-of-dynavax/2275344
Context: Portfolio includes HEPLISAV-B (two-dose adult hepatitis B vaccine) and Z-1018 shingles candidate in Phase 1/2.
Key point: Transaction closed via tender offer and merger; Dynavax becomes wholly owned Sanofi subsidiary.
Implication: Signals pipeline investment and modality expansion.

🇲🇽 Mexico–Moderna MOU for local mRNA manufacturing and clinical research [6] [Mexico • 10 Feb 2026]

https://mexicobusiness.news/health/news/moderna-advances-local-mrna-vaccine-production-mexico
Context: Phased tech transfer from fill-finish to drug substance, aligned with Plan México; COFEPRIS approval and procurement noted.
Key point: Five-year agreement with government, BIRMEX, and Liomont to build mRNA capacity, supply respiratory vaccines, and run local R&D.
Implication: May expand screening, initiation, and follow-up at scale.

💉 FDA issues Refusal-to-File for Moderna mRNA-1010 influenza BLA [7] [US • 10 Feb 2026]

https://feeds.issuerdirect.com/news-release.html?newsid=7346090610333866&symbol=MRNA
Context: Moderna plans Type A meeting; EU, Canada, Australia reviews underway; company cites two positive Phase 3 studies.
Key point: CBER refused to initiate review citing comparator choice; no specific safety or efficacy concerns raised in letter.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

mRNA delivery and OMV platforms continue to broaden vaccine design and potential repeat dosing.
National manufacturing strategies in Mexico and regulatory progress in China show regional supply-chain shifts.
Public health programs in India and China target endemic and seasonal respiratory threats with localized evidence.
Corporate moves reshape adult immunization portfolios and future competition.
FDA’s stance on comparators underscores how trial design choices affect US approval pathways.

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FAQ

What did NeoVac actually show in humans?

NeoVac reported first-in-human Phase I/II data for an mRNA–LNP COVID-19 candidate with favorable safety and biological activity vs authorized mRNA vaccines, per a Lancet-hosted preprint and company statements [1].

What stage is Delonix’s DX-104 now entering?

With NMPA IND clearance in China and prior Australian CTN and ethics approval, Delonix plans to start Phase I to assess safety and immunogenicity of its engineered OMV MenB vaccine [2].

What is the design of India’s new KFD vaccine program?

ICMR and IIL are testing a fully indigenous, two-dose, adjuvanted inactivated vaccine given 28 days apart, starting with Phase I after animal challenge and toxicity work [3].

What does China’s acceptance of Arexvy mean?

China’s CDE accepted GSK’s application for Arexvy in adults 60+. The filing includes a Phase III immuno-bridging study in China that met primary endpoints; a decision is expected in 2027 [4].

What products did Sanofi gain from Dynavax?

Sanofi now owns HEPLISAV-B, a two-dose adult hepatitis B vaccine, and Z-1018, a shingles candidate in Phase 1/2, along with other pipeline projects [5].

Why did FDA refuse to file Moderna’s mRNA-1010 BLA?

CBER cited the choice of comparator as not reflecting best-available standard of care. The letter did not specify safety or efficacy concerns. Reviews continue in the EU, Canada, and Australia [7].

Entities / Keywords

NeoVac; mRNA–LNP; COVID-19 vaccine; Delonix Bioworks; DX-104; OMV Plus; MenB; ICMR; Indian Immunologicals Limited; Kyasanur Forest Disease; GSK; Arexvy; RSV; China CDE; Sanofi; Dynavax; HEPLISAV-B; Z-1018; Moderna; mRNA-1010; FDA CBER; BIRMEX; Laboratorios Liomont; COFEPRIS; Mexico manufacturing.