Dive Brief:

• After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 years and older.
• The biotechnology company said it plans to resubmit its candidate later this year after it gathers data from an ongoing Phase 3 trial of a standalone seasonal influenza vaccine it’s developing. Earlier this month, Moderna had told investors the FDA would require efficacy data from this trial before considering approval of the combo vaccine.
• Moderna’s confirmation comes one day after the FDA announced new rules for COVID vaccine approvals, for which it will now require placebo-controlled studies for any clearance in healthy adults under 65 years old.

Dive Insight:

COVID vaccines have been scrutinized by new leadership at the Department of Health and Human Services and at the FDA, where Commissioner Martin Makary and newly installed top vaccine official Vinay Prasad have set stricter standards. 

The two co-authored an article published in The New England Journal of Medicine Tuesday, shifting the FDA’s past approach of approving updated COVID vaccines on “immunogenicity” data alone to a new age- and risk-based framework.

While the changes will raise requirements for broad OKs in healthy adults and children, analysts described them as manageable for larger companies like Pfizer and even Moderna. Shares in Moderna, which have fallen steadily since the heights of the pandemic, rose by more than 6% Tuesday.

But the stock gave back all of those gains Wednesday morning on news of Moderna’s decision to withdraw its application. During a May earnings call, Moderna executives had said they weren’t sure whether they would need to pull the filing, or whether they could instead add it as a “major amendment” to the submission.

While another setback, the announcement is “unsurprising in light of previous commentary on longer review timelines,” Leerink analyst Mani Foroohar wrote in a Wednesday note to clients.

The FDA is set to make an approval decision on Moderna’s next-generation COVID vaccine at the end of this month, and on an expanded clearance for its respiratory syncytial virus vaccine next month.

Moderna has been grappling with declining revenue for both its existing COVID vaccine and its RSV shot.