Moderna’s flu vaccine, a crucial plank underpinning its post-pandemic strategy, has disappointed – and the main problem is not, as might have been expected, its side-effect profile. Compared with an approved seasonal flu vaccine in its phase 3 immunogenicity trial, mRNA-1010 more or less worked on influenza A variants, but missed entirely on the less common B strains. Safety does remain a worry, with 70% of mRNA-1010 recipients reporting solicited adverse reactions versus 48% in the comparator group. Moderna’s share price dropped 5% in early trade. mRNA-1010 has another chance: Moderna is also conducting a much larger efficacy trial with an updated version of the vaccine designed to improve immune responses against influenza B. An interim efficacy analysis of this trial will occur by the end of next month, though chances of stoppage for efficacy at that point now seem low. But there is a bigger question: might reactogenicity be a problem for Moderna’s entire platform? With several flu jabs in the clinic, including combination Covid and RSV vaccines, Moderna has a lot to lose if so. And if the problem is common to all mRNA-based vaccines, Pfizer, Sanofi and GSK are in the danger zone too.
| mRNA-1010's performance vs comparator vaccine in Ph3 (NCT05415462) | ||
|---|---|---|
| Endpoint | ||
| Flu strain | Seroconversion rates | Geometric mean titre ratios |
| A/H3N2 | Superior | Superior |
| A/H1N1 | Superior | Non-inferior |
| B/Victoria- lineage | No effect | No effect |
| B/Yamagata-lineage | No effect | No effect |
| Source: company release. | ||
| mRNA influenza vaccines | ||
|---|---|---|
| Project | Company | Data and trial |
| mRNA-1010 | Moderna | Ph3 immunogenicity trial (NCT05415462) in 6,100 pts reported mixed data Feb 2023 |
| Ph3 efficacy trial (NCT05566639) in 23,000 pts, PCD Dec 2023 | ||
| PF-07252220 | Pfizer/Biontech | Ph3 trial (NCT05540522) in 36,200 pts, PCD Aug 2023 |
| mRNA-1073 (Covid and flu) | Moderna | Ph1/2 trial (NCT05375838) in 550 pts, PCD Jun 2023 |
| mRNA 1010, mRNA-1020 and mRNA-1030 | Moderna | Ph1/2 trial (NCT05333289) in 572 pts, completed but no results released |
| SP0273/MRT5407 | Sanofi | Ph1/2 trial (NCT05553301) in 560 pts, PCD Jan 2024 |
| GSK4382276A (FLU SV mRNA) | GSK/Curevac | Ph1 trial (NCT05446740) in 198 pts, PCD Jun 2023 |
| CVSQIV | GSK/CureVac | Ph1 trial (NCT05252338) in 240 pts, had a PCD of Oct 2022, but trial status is "recruiting" |
| mRNA-1045 (flu and RSV) and mRNA-1230 (flu, RSV, and Covid), compared with mRNA-1010 (flu), mRNA-1345 (RSV) and mRNA-1273.214 (Covid) | Moderna | Ph1 trial (NCT05585632) in 675 pts, PCD Mar 2024 |
| PF-07252220 (flu) plus bivalent Comirnaty (Covid) | Pfizer/Biontech | Ph1 trial (NCT05596734) in 360 pts, PCD Jun 2024 |
| PCD = primary completion date. Source: Evaluate Pharma, clinicaltrials.gov & company statements. https://www.evaluate.com/vantage/articles/news/trial-results-snippets/modernas-post-covid-prospects-dim | ||
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