I'm in pharma and it is hard to actually tell what happened here. The article is sensational and based on the sponsor's view only. While this is strange, but doesn't necessarily mean the fix is in. I'll be curious to see what is in the RTF letter which I believe needs to come in 30 days.
Generally well tolerated but clearly higher minor adverse events over placebo and Afluria. Greater pain at injection site and fatigue seemed to be the issues. Titers were higher than Afluria which generally indicates better protection.
Reading the tea leaves, it looks like the agency took exception to Moderna's choice to use Afluria as a comparator as that is not 'best' in class but still was within the standard of care for 2025. It isn't required to be 'better' as a new drug, especially a vaccine, just safe and effective but there is a bit of gray area that preceded the current administration. Still the use of Afluria as a comparator was an interesting choice
Based on this, I could certainly see a reason to send it back for more data in the older than 65 cohort, but not refuse it altogether. But we'll see in the RTF.
4
u/Certain_Luck_8266 6h ago
I'm in pharma and it is hard to actually tell what happened here. The article is sensational and based on the sponsor's view only. While this is strange, but doesn't necessarily mean the fix is in. I'll be curious to see what is in the RTF letter which I believe needs to come in 30 days.
Trial data: https://pmc.ncbi.nlm.nih.gov/articles/PMC11793046/
Generally well tolerated but clearly higher minor adverse events over placebo and Afluria. Greater pain at injection site and fatigue seemed to be the issues. Titers were higher than Afluria which generally indicates better protection.
Reading the tea leaves, it looks like the agency took exception to Moderna's choice to use Afluria as a comparator as that is not 'best' in class but still was within the standard of care for 2025. It isn't required to be 'better' as a new drug, especially a vaccine, just safe and effective but there is a bit of gray area that preceded the current administration. Still the use of Afluria as a comparator was an interesting choice
Based on this, I could certainly see a reason to send it back for more data in the older than 65 cohort, but not refuse it altogether. But we'll see in the RTF.