Moderna Withdraws Combo COVID-19/Flu Vaccine Application Amid Shifting FDA Requirements

Moderna has voluntarily withdrawn its application for a combination COVID-19 and influenza vaccine for adults aged 50 and older following discussions with the U.S. Food and Drug Administration (FDA). This development comes amid new, stricter FDA guidelines for COVID-19 vaccine approvals and ongoing clinical trials for standalone influenza vaccines.

FDA Sets New Standards for COVID-19 Vaccine Approvals

The FDA has announced new rules for COVID-19 vaccine approvals, requiring placebo-controlled studies for clearance in healthy adults under 65 years old. This shift in approach, outlined by FDA Commissioner Martin Makary and newly installed top vaccine official Vinay Prasad in The New England Journal of Medicine, moves away from the previous practice of approving updated COVID-19 vaccines based solely on immunogenicity data.

The new age- and risk-based framework aims to raise the bar for broad approvals in healthy adults and children. While these changes may pose challenges for some vaccine developers, analysts suggest they remain manageable for larger companies like Pfizer and Moderna.

Moderna's Strategic Pivot and Market Response

Moderna plans to resubmit its Biological License Application (BLA) for the combination vaccine, known as mRNA-1083, later this year. The company will incorporate data from an ongoing Phase 3 trial of its standalone seasonal influenza vaccine, mRNA-1010, with interim results expected this summer.

The withdrawal announcement erased Moderna's 6% stock gain from the previous day, with shares dropping 4.5% to $26.79 when markets opened on Wednesday. Despite this setback, Leerink analyst Mani Foroohar described the move as "unsurprising in light of previous commentary on longer review timelines."

Moderna faces additional challenges, including declining revenue for both its existing COVID-19 vaccine and its respiratory syncytial virus (RSV) shot. However, the company anticipates FDA decisions on its next-generation COVID-19 vaccine by the end of May and on an expanded clearance for its RSV vaccine next month.

Implications for the Pharmaceutical Industry

The FDA's evolving approach to vaccine regulation has broader implications for the pharmaceutical industry. The Department of Health and Human Services recently announced that all new vaccine trials must include a full placebo arm, a decision that has sparked debate among industry observers.

Leerink Partners expressed concerns about this requirement, stating that "placebo-controlled trials are unnecessary and unethical for many populations" and suggesting that "the world will look to other countries' health authorities as the gold standards for vaccine testing."

As the regulatory landscape continues to shift, pharmaceutical companies must adapt their strategies to meet new standards while advancing innovative vaccine technologies. The outcome of Moderna's upcoming trials and regulatory decisions will likely set important precedents for the industry moving forward.