With the pandemic cash flowing Moderna is investing heavily in vaccines for other infectious diseases, but poor tolerability, known to be an issue with its Covid vaccine, could become a broader problem. At an R&D day yesterday new data on its flu project mRNA-1010 showed systemic and local adverse events at double the rates seen with CSL’s Afluria, which was used as control in a phase 2 trial. Antibody responses were comparable, but the project’s reactogenicity profile is a commercial and clinical “non-starter”, according to Leerink analysts, who believe further development to be a “poor use of resources”. This is an issue unlikely to be restricted to flu and Covid. Jacqueline Miller, Moderna’s head of infectious disease development, said the group's RSV candidate displayed a similar adverse event profile to the rest of the vaccine platform. The next dataset to scrutinise will be cytomegalovirus – data from a 6,900-patient trial are due towards the end of 2022. Meanwhile, the company is also investing heavily in next-gen Covid offerings, but the pandemic windfall will end, and Moderna still needs to prove that it has a technology capable of competing in less urgent circumstances.
| Moderna's plan for a post-Covid world – projects to watch | ||
|---|---|---|
| Project | Setting | Next steps |
| mRNA-1010 | Flu | In preparations for ph3 |
| mRNA-1073 | Covid+Flu | To enter the clinic this year |
| mRNA-1230 | Covid+Flu+RSV for adults >50 | Preclinical development |
| mRNA-1345 | RSV older adults | Pivotal Conquer RSV trial started Nov 2021; results expected YE'24 |
| mRNA-1647 | Cytomegalovirus | Ph3 under way; results expected H2'22 |
| mRNA-1189 | Epstein-Barr (infectious mononucleosis) | Ph1 results expected H2'23 |
| mRNA-1644 | HIV | Ph1 initiated early 2022 |
| mRNA-1574 | HIV | Ph1 getting under way Mar 2022 |
| mRNA-1893 | Zika | Ph2 under way |
| Source: company presentation. https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/moderna-needs-dispel-doubts-about-its-post-covid | ||
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