Industry Insights: mRNA milestones, industry restructuring, and regulatory upheavals in a turbulent month for vaccines

Thermostable fridge-free tetanus and diphtheria vaccine SPVX02 completed Phase 1 and advanced to next stage of clinical development [1]Gov UK. UKHSA and Stablepharma highlight breakthrough with fridge-free tetanus and diphtheria vaccine. 2026; Gov UK Press Release.

The UK Health Security Agency (UKHSA) and Stablepharma Ltd announced the completion of Phase 1 trials of SPVX02, a thermostable, fridge-free tetanus and diphtheria vaccine. Evaluation of trial results at UKHSA's Vaccine Development and Evaluation Centre indicated that SPVX02 is effective without refrigeration after storage at 30 °C for 24 months. The vaccine will begin a larger clinical trial in healthy participants, comparing its effectiveness against a licensed European vaccine, with UKHSA continuing to assess immune responses. The program, supported by Innovate UK and the National Institute for Health and Care Research Southampton Clinical Research Facility, aims to address cold-chain barriers to global vaccine distribution, particularly in low-resource and emergency settings.

World-first personalized pediatric mRNA cancer vaccine trial initiated for children with high-grade brain tumors [2]Providence Therapeutics. Providence Therapeutics Announces World-First Personalized Pediatric mRNA Cancer Vaccine Trial. 2026; Providence Therapeutics Press Release.

Providence Therapeutics announced the launch of PaedNEO-VAX, the first multi-site personalised mRNA cancer vaccine trial in children and adolescents with relapsed or refractory high-grade brain tumors, including high-grade glioma, diffuse midline glioma, medulloblastoma, and ependymoma. The Phase 1/2 trial, co-led by the University of Queensland and the South Australian Health and Medical Research Institute, will be conducted across eight pediatric hospitals in Australia. Phase 1 will assess safety and optimal dosing; Phase 2 will evaluate clinical outcomes, including disease progression and survival. Tumor-specific mRNA vaccines will be designed using genome sequencing and manufactured by Southern RNA, with an expected turnaround of approximately 10 weeks from enrolment to dosing. Providence Therapeutics is contributing its INTENT™ lipid nanoparticle delivery platform.

Self-amplifying mRNA COVID-19 vaccine GRT-R910 demonstrated safety and immunogenicity as a booster in Phase 1 study [3]Whitaker JA, Rebolledo PA, Abate G, et al. The safety, reactogenicity, and immunogenicity of the self-amplifying mRNA COVID-19 vaccine GRT-R910 as a booster in healthy adults. Elsevier 2026; 77, 128358.

Phase 1 data were published for GRT-R910, a self-amplifying mRNA (saRNA) vaccine expressing SARS-CoV-2 (D614G) spike protein and T cell epitopes, evaluated as a booster in 48 previously vaccinated or infected healthy adults. Single doses of 3–10 μg were administered across age groups (18–60 years and >60 years). Most participants experienced mild-to-moderate reactions; 17% had severe systemic reactions. Pseudovirus neutralizing antibody geometric mean fold rise responses were durable to Day 181 across most dose groups, with the 3 μg dose performing comparably to or better than higher doses, potentially reflecting higher baseline geometric mean titers in the 6 and 10 μg groups. Findings support saRNA as a viable, dose-efficient booster platform against COVID-19.

Moderna reached $2.25 billion settlement with Genevant Sciences and Arbutus Biopharma to resolve LNP patent dispute [4]Moderna. Moderna Resolves Global Patent Litigation with Arbutus/Genevant. March 3, 2026. Moderna reached a global settlement with Genevant Sciences and Arbutus Biopharma on March 3, 2026, resolving all patent-infringement litigation arising from Moderna's use of LNP delivery technology in its COVID-19 vaccines. Under the terms, Moderna will pay $950M upfront in July 2026 and a further $1.3B contingent on the outcome of a pending appellate ruling regarding government contractor immunity under US law. Moderna has consented to a court judgment of infringement and no invalidity on four patents. In return, Genevant grants Moderna a global non-exclusive license to its LNP delivery technology for SM-102-containing mRNA vaccines for infectious disease. Separate Pfizer/BioNTech litigation over the same LNP patents remains ongoing in the USA.

Bavarian Nordic and Serum Institute of India expand chikungunya vaccine partnership; Market Trends. Credit: iStock.

BioNTech co-founders announced plans to establish independent mRNA-focused company, with BioNTech contributing technology in exchange for minority stake [5]BioNTech. BioNTech and Co-Founders Announce Plan to Pursue Next-Generation mRNA Innovations in Co-Founders-Led New Company as BioNTech Advances Toward Becoming a Multi-Product Company by 2030. March 10, 2026.

BioNTech announced on March 10, 2026 that co-founders Ugur Sahin and Özlem Türeci will establish an independent biotechnology company focused on next-generation mRNA innovations, with both transitioning out of their current roles at BioNTech by the end of 2026. BioNTech plans to contribute related mRNA rights and technologies to the new company on an arm's length basis in exchange for a minority stake, milestones, and royalties. A binding agreement is expected to be signed by the end of the first half of 2026. BioNTech stated that its existing clinical pipeline, including its COVID-19 vaccine franchise and 15 planned Phase 3 oncology trials, will remain unaffected. Further details will be communicated following the signing of the binding agreement.

SK bioscience, IDT Biologika, and Vaxxas selected for EU-funded next-generation influenza vaccine development programme [6]SK Bioscience. SK bioscience, IDT Biologika and Vaxxas Selected for Next-Generation Influenza Vaccine development Financed by the European Union. February 26, 2026.

SK bioscience, IDT Biologika, and Vaxxas announced their selection for Phase 1 of a next-generation vaccine development initiative managed by the European Health and Digital Executive Agency on behalf of the European Commission's Health Preparedness and Response Authority. The consortium will develop a seasonal influenza vaccine for older adults and a pandemic influenza vaccine using Vaxxas' high-density microarray patch (HD-MAP) needle-free delivery technology. HaDEA will provide up to €12.9M to support Phase 1, including a Phase 1 clinical trial, as part of a broader framework valued at up to €225M across three contracts. HD-MAP vaccines are designed to achieve comparable immunogenicity with lower antigen doses and offer room-temperature stability. IDT Biologika will serve as project lead and European manufacturing hub.

Bavarian Nordic transferred chikungunya vaccine manufacturing to Serum Institute of India to scale supply for low- and middle-income countries [7]Bavarian Nordic. Bavarian Nordic and Serum Institute of India expand strategic partnership with chikungunya vaccine manufacturing agreement. March 11, 2026.

Bavarian Nordic announced an expansion of its strategic partnership with Serum Institute of India (SII) to include a contract manufacturing agreement covering a full technology transfer of the manufacturing process for its chikungunya virus-like particle (VLP) vaccine, CHIKV VLP (Vimkunya^®), to enable future supply to endemic low- and middle-income countries. The agreement replaces a previously entered arrangement with Biological E. Limited and builds on an existing mpox vaccine license and manufacturing agreement with SII. The expanded collaboration also provides for potential future co-development opportunities. CHIKV VLP is a single-dose, adjuvanted recombinant protein vaccine approved by the US FDA, European Commission, and Medicines and Healthcare products Regulatory Agency in 2025, with regulatory review ongoing in Switzerland and Canada.

CK Life Sciences established Sequencio Therapeutics to consolidate therapeutic cancer vaccine portfolio [8]CK Life Sciences. Voluntary announcement relating to establishment of Sequencio Therapeutics Company Limited to advance therapeutic cancer vaccines development. March 10, 2026.

CK Life Sciences announced the establishment of Sequencio Therapeutics Company Limited, a wholly-owned subsidiary dedicated to advancing its therapeutic cancer vaccine pipeline. Sequencio's preclinical portfolio includes vaccine candidates targeting Trophoblast Cell Surface Antigen 2 (TROP2), which demonstrated robust T cell immune responses and tumor growth inhibition in preclinical breast and colorectal cancer mouse studies, alongside candidates targeting preferentially expressed antigen in melanoma (PRAME), programmed cell death ligand 1 (PD-L1), B7 homolog 3 (B7-H3), and claudin 6. Vaccine discovery and design will be conducted in-house, with development advanced through internal capabilities and external collaborations. The subsidiary was established to consolidate CK Life Sciences' therapeutic cancer vaccine R&D under a dedicated organization.

European Medicines Agency issued positive recommendation for Moderna's combination mRNA flu/COVID-19 vaccine [9]European Medicines Agency. mCombriax. February 27, 2026. On February 27, 2026, the European Medicines Agency (EMA) issued a positive recommendation for approval of Moderna's combination influenza and COVID-19 mRNA vaccine, mCombriax, for adults aged 50 years and older – making it the world's first combination flu/COVID vaccine to receive a regulatory recommendation. The EMA's decision diverges from the FDA's position; Moderna's application for the equivalent product (mRNA-1073) in the US has faced a more challenging regulatory path under the current administration. Official clearance for use in the EU is subject to ratification by the European Commission.

EMA issues positive recommendation for world-first combination flu/COVID-19 mRNA vaccine; Regulation and Policy. Credit: (European Medicines Agency).

VRBPAC unanimously recommended viral strains for the 2026–27 influenza season at first meeting under current US administration [10]FDA. Influenza Vaccine Composition for the 2026-2027 U.S. Influenza Season. March 12, 2026.

The US FDA's Vaccine and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended viral strains for the 2026–27 influenza season at a meeting held on March 12, 2026 – the first such meeting under the current administration. The meeting took place against a backdrop of disruption to the US vaccine regulatory advisory process, including the cancellation of an Advisory Committee on Immunization Practices meeting scheduled for March 18–19.

Coalition of 14 state attorneys general and Governor of Pennsylvania filed lawsuit challenging CDC Decision Memo that removed universal recommendation status from seven childhood vaccines [11]State of California Department of Justice. Attorney General Bonta Co-Leads Multistate Lawsuit to Block Trump Administration's Unlawful Overhaul to Childhood Vaccine Schedule. March 5, 2026. A multistate lawsuit (State of Arizona et al. v Kennedy et al.) was filed on February 24, 2026 by 14 state attorneys general and the Governor of Pennsylvania in the US District Court for the Northern District of California, challenging the January 5, 2026 CDC Decision Memo that stripped seven childhood vaccines (protecting against rotavirus, meningococcal disease, hepatitis A, hepatitis B, influenza, COVID-19, and RSV) of their universally recommended status. The lawsuit also challenges Secretary Kennedy's replacement of Advisory Committee on Immunization Practices members. Plaintiffs argue both actions violated the Federal Advisory Committee Act, which requires advisory committees to be balanced in membership and to follow transparent appointment processes. The coalition is seeking declaratory and injunctive relief to have both the new schedule and appointments declared unlawful and set aside.

Multistate lawsuit challenges removal of universal childhood vaccine recommendations; Regulation and Policy, page 136. Credit: iStock.

FDA CBER director Vinay Prasad resigned [12]Choudhury K and Erman M. FDA vaccines chief Vinay Prasad to leave regulator in April. Reuters. March 6, 2026.

On 6 March 2026, Dr Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), the division responsible for approving vaccines, blood products, and cell and gene therapies, announced his resignation after a short tenure, with his departure effective at the end of April. Prasad's tenure had been marked by controversy, including disputes over CBER's handling of Moderna's mRNA influenza vaccine application and disagreements over the regulatory path for gene therapies and rare disease drugs. His departure adds to ongoing uncertainty surrounding the FDA's vaccine regulatory leadership.

US FDA launched unified Adverse Event Monitoring System to replace fragmented legacy reporting platforms [13]FDA. FDA Launches New Adverse Event Look-Up Tool. March 11, 2026.

The US FDA launched the Adverse Event Monitoring System (AEMS), a unified platform consolidating adverse event reporting across drugs, biologics, vaccines, cosmetics, and animal food into a single dashboard. AEMS replaces seven legacy databases, including the FDA Adverse Event Reporting System and the Vaccine Adverse Event Reporting System. By end of May 2026, AEMS will contain real-time adverse event reports for all US FDA-regulated products, replacing quarterly publication. The agency projects savings of approximately $120M over 5 years. Historical adverse event data will be migrated to AEMS, and enhanced application program interfaces and data analytics tools will be rolled out in the coming months.

EMA's Pharmacovigilance Risk Assessment Committee recommended update to Ixchiq product information following aseptic meningitis cases in healthy young adults [14]European Medicine Agency. PRAC warns about known risk of aseptic meningitis with chikungunya vaccine Ixchiq. March 13, 2026.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) completed a review of a safety signal for aseptic meningitis with Ixchiq, a live attenuated chikungunya vaccine, and recommended an update to the vaccine's product information. The review was triggered by a reported case of aseptic meningitis in a healthy young adult following vaccination. While aseptic meningitis is already listed as a known side effect of Ixchiq at unknown frequency, the product information will now be updated to reflect that serious neurological side effects have also been observed in healthy young adults, not only in individuals aged over 65 years or those with multiple long-term medical conditions. A 6-monthly periodic safety update report assessment is ongoing and will conclude in June 2026.

Ashling Cannon, Commissioning Editor of Vaccine Insights, works with leading scientists and industry experts to develop high-impact, open-access content across vaccine R&D and manufacturing. She holds a BSc (Hons) in Biological Sciences and an MSc in Wild Animal Biology, with experience in biotechnology and clinical research publishing across journals and books.

References

1. Gov UK. UKHSA and Stablepharma highlight breakthrough with fridge-free tetanus and diphtheria vaccine. 2026; Gov UK Press Release.

2. Providence Therapeutics. Providence Therapeutics Announces World-First Personalized Pediatric mRNA Cancer Vaccine Trial. 2026; Providence Therapeutics Press Release.

3. Whitaker JA, Rebolledo PA, Abate G, et al. The safety, reactogenicity, and immunogenicity of the self-amplifying mRNA COVID-19 vaccine GRT-R910 as a booster in healthy adults. Elsevier 2026; 77, 128358.

4. Moderna. Moderna Resolves Global Patent Litigation with Arbutus/Genevant. March 3, 2026.

5. BioNTech. BioNTech and Co-Founders Announce Plan to Pursue Next-Generation mRNA Innovations in Co-Founders-Led New Company as BioNTech Advances Toward Becoming a Multi-Product Company by 2030. March 10, 2026.

6. SK Bioscience. SK bioscience, IDT Biologika and Vaxxas Selected for Next-Generation Influenza Vaccine development Financed by the European Union. February 26, 2026.

7. Bavarian Nordic. Bavarian Nordic and Serum Institute of India expand strategic partnership with chikungunya vaccine manufacturing agreement. March 11, 2026.

8. CK Life Sciences. Voluntary announcement relating to establishment of Sequencio Therapeutics Company Limited to advance therapeutic cancer vaccines development. March 10, 2026.

9. European Medicines Agency. mCombriax. February 27, 2026.

10. FDA. Influenza Vaccine Composition for the 2026-2027 U.S. Influenza Season. March 12, 2026.

11. State of California Department of Justice. Attorney General Bonta Co-Leads Multistate Lawsuit to Block Trump Administration's Unlawful Overhaul to Childhood Vaccine Schedule. March 5, 2026.

12. Choudhury K and Erman M. FDA vaccines chief Vinay Prasad to leave regulator in April. Reuters. March 6, 2026.

13. FDA. FDA Launches New Adverse Event Look-Up Tool. March 11, 2026.

14. European Medicine Agency. PRAC warns about known risk of aseptic meningitis with chikungunya vaccine Ixchiq. March 13, 2026.