Moderna FDA Briefing Document Outlook

Goldman Sachs maintains a Neutral rating on Moderna ahead of a VRBPAC meeting on June 18, viewing the FDA's briefing documents for the mFLUSIVA vaccine as supportive of approval.

Key Takeaways

• 1.The FDA briefing document for Moderna's mFLUSIVA vaccine appears positive for approval, noting no major deficiencies and confirming success criteria were met.
• 2.The FDA is considering a bifurcated regulatory approach: traditional approval for adults 50-64 based on efficacy, and accelerated approval for 65+ based on immunogenicity.

Table of Contents

• Key Takeaways
• Valuation and Risks
• Disclosure Appendix

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