Cautious Outlook on Moderna’s mNexspike Vaccine Amid Restrictive FDA Approval and Regulatory Changes

William Blair analyst Myles Minter has reiterated their neutral stance on MRNA stock, giving a Hold rating today.

Myles Minter has given his Hold rating due to a combination of factors related to the recent FDA approval of Moderna’s next-generation COVID-19 vaccine, mNexspike. The approval comes with a more restrictive label, limiting its use to adults aged 65 and older, and individuals aged 12-64 with risk factors for severe COVID-19. This is more restrictive compared to the broader label of Moderna’s first-generation vaccine, Spikevax, which is approved for all individuals aged 12 and above.
The restrictions align with updated regulatory guidelines from the Center for Biologics Evaluation and Research, which suggest that immunologic biomarker-based endpoints are sufficient for approval in high-risk groups, while broader approvals may require placebo-controlled studies. Moderna’s Phase III NextCOVE study, which supported the FDA approval, used an active comparator instead of a placebo, placing it in a middle ground according to these guidelines. The resultant label for mNexspike is similar to Novavax’s Nuvaxovid, suggesting that both approvals were influenced by the updated regulatory framework. These factors contribute to the Hold rating as they indicate a cautious outlook on the vaccine’s market potential under the current regulatory landscape.

In another report released today, Barclays also maintained a Hold rating on the stock with a $40.00 price target.