Moderna's Combination Flu-COVID Shot Faces FDA Delay Amid Regulatory Scrutiny

Moderna's ambitious plan to bring a combination flu and COVID-19 vaccine to market has hit a significant roadblock, as the U.S. Food and Drug Administration (FDA) requests additional data before considering approval. This development, announced alongside Moderna's first-quarter earnings report, signals a potential shift in the regulatory landscape for vaccine approvals under new agency leadership.

FDA Demands Additional Efficacy Data

The biotechnology company revealed that the FDA has communicated a requirement for Phase 3 flu efficacy data before issuing clearance for the combination shot. This request comes despite Moderna's previous filing based on a late-stage study demonstrating immune responses against both viruses in adults 50 years and older. As a result, the approval decision, initially expected this year, may now be delayed until 2026.

Moderna's president, Stephen Hoge, emphasized that the company's recent interactions with the FDA have been "business as usual," despite the appointments of vaccine skeptic Robert F. Kennedy Jr. as Health and Human Services Secretary and new commissioner Martin Makary. Hoge noted that the agency's request for additional flu shot data "makes good scientific sense."

Broader Implications for Vaccine Development

The delay in Moderna's combination shot approval is not an isolated incident. It comes amid an unusual regulatory delay for fellow COVID-19 vaccine developer Novavax and indications from the Department of Health and Human Services (HHS) that new shots will need to be tested in placebo-controlled trials prior to regulatory approval.

Wall Street analysts view these developments as evidence of increased scrutiny and potentially higher standards for success in vaccine development, especially for novel vaccines. Leerink Partners analyst Mani Foroohar suggested that this heightened bar could "negatively impact" the regulatory path for Moderna's combination shot.

Financial Impact and Strategic Adjustments

In response to these challenges and broader market pressures, Moderna is implementing significant cost-cutting measures. The company aims to reduce annual spending by $1.5 billion by 2027, which includes deprioritizing the development of the combination vaccine in younger adults.

Moderna's financial performance reflects the challenging environment, with first-quarter revenue dropping to $108 million from $167 million in the same period last year. The company's stock price has also suffered, losing approximately half its value over the past six months and falling an additional 5% following the announcement.

As the pharmaceutical industry navigates this evolving regulatory landscape, upcoming decisions on Moderna's new COVID shot and expanded use of its respiratory syncytial virus vaccine in younger adults are seen as "litmus tests" for vaccine regulation. These decisions, expected by mid-June, will likely provide further insight into the FDA's approach under its new leadership.