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

Across mid-February to mid-March 2026, the vaccine landscape was marked by significant regulatory activity, major industry restructuring, and continued clinical progress across multiple platforms. The European Medicines Agency issued a positive recommendation for the world's first combination influenza and COVID-19 mRNA vaccine, while the US FDA's vaccine regulatory environment remained unsettled, with the resignation of the Center for Biologics Evaluation and Research director, ongoing legal challenges to childhood vaccine policy changes, and the launch of a new unified adverse event reporting platform. In clinical development, first-in-human and first-in-world trials advanced for a pan-influenza universal vaccine candidate and a personalised paediatric mRNA cancer vaccine, respectively. Market activity was headlined by Moderna's $2.25B settlement with Genevant Sciences and Arbutus Biopharma resolving long-running lipid nanoparticle patent litigation, and the announcement that BioNTech's co-founders will establish an independent mRNA-focused company.

Authors

Publication Details

Journal
Vaccine Insights
Published
2026-04-14
DOI
https://doi.org/10.18609/vac.2026.021
Primary Topic
RNA Interference and Gene Delivery
Type
article
Field-Weighted Citation Impact
0.00
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article

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

Ashling Cannon
Vaccine Insights
RNA Interference and Gene Delivery
article

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

Ashling Cannon
article en

Abstract

Across mid-February to mid-March 2026, the vaccine landscape was marked by significant regulatory activity, major industry restructuring, and continued clinical progress across multiple platforms. The European Medicines Agency issued a positive recommendation for the world's first combination influenza and COVID-19 mRNA vaccine, while the US FDA's vaccine regulatory environment remained unsettled, with the resignation of the Center for Biologics Evaluation and Research director, ongoing legal challenges to childhood vaccine policy changes, and the launch of a new unified adverse event reporting platform. In clinical development, first-in-human and first-in-world trials advanced for a pan-influenza universal vaccine candidate and a personalised paediatric mRNA cancer vaccine, respectively. Market activity was headlined by Moderna's $2.25B settlement with Genevant Sciences and Arbutus Biopharma resolving long-running lipid nanoparticle patent litigation, and the announcement that BioNTech's co-founders will establish an independent mRNA-focused company.

Vaccine InsightsVol. 5(2)
Partnerships for the goals
Openalex Percentile: Top 8%
RNA Interference and Gene Delivery
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