Why was Moderna's mRNA flu vaccine rejected by the FDA?

Moderna's mRNA flu vaccine was rejected by the FDA's vaccine division leader due to concerns that the control group in its Phase 3 trial did not receive the 'best-available standard of care.'

What is the impact of the FDA's decision on Moderna's flu vaccine?

The rejection of Moderna's flu vaccine is seen as a move that hinders medical innovation and is discouraging investment in new vaccines and drugs.

Have other innovative drugs been rejected by the FDA recently?

Yes, the FDA has also recently rejected Regenxbio's gene therapy for Hunter syndrome, marking the third rare disease drug rejected by the division in recent months.

Home / Health / FDA Vaccine Chief Blocks Moderna Flu Shot

FDA Vaccine Chief Blocks Moderna Flu Shot

12 Feb

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Summary

Moderna's flu vaccine was rejected without a thorough review by the FDA.
The rejection was due to the control group not receiving the "best-available standard of care."
This decision discourages investment in innovative vaccines and drugs, impacting future R&D.

FDA Vaccine Chief Blocks Moderna Flu Shot

Vinay Prasad, leader of the Food and Drug Administration's vaccine division, has reportedly rejected Moderna's mRNA flu vaccine without a comprehensive review. This action is criticized as arbitrary government overreach, as the FDA typically reviews applications thoroughly. Prasad questioned the adequacy of Moderna's Phase 3 trial, specifically the control group's standard of care.

Moderna's trial, which involved 41,000 participants, showed its vaccine to be more effective than standard flu vaccines. However, Prasad insisted on a high-dose vaccine control, which is not readily available internationally where the trial was conducted and is generally reserved for seniors in the U.S.

This regulatory stance, along with the rejection of Regenxbio's gene therapy, has negatively impacted morale at the FDA and is discouraging investment in innovative medical treatments. Moderna's CEO has indicated a pause in investing in new vaccine trials due to this regulatory uncertainty.

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