Moderna Retracts US Approval Request for Dual Flu-Covid Vaccine

Published: Thursday, May 22, 2025 at 12:51 am

Moderna Pulls Back on Combo Vaccine Application, Resubmission Planned

Moderna has withdrawn its application for US approval of a combined flu and COVID-19 vaccine, the company announced Wednesday. The move follows discussions with the US Food and Drug Administration (FDA). Moderna plans to resubmit the application later this year, incorporating efficacy data from a late-stage trial of its seasonal influenza vaccine, expected to be released this summer.

This decision arrives on the heels of the FDA's announcement requiring new clinical trials for annual COVID-19 boosters for healthy individuals under 65. The regulatory landscape is clearly shifting, impacting vaccine manufacturers like Moderna.

The company's stock has been under pressure recently, facing headwinds from declining COVID-19 revenue. Investor concerns have also been fueled by the appointment of Robert F. Kennedy Jr. as Secretary of Health and Human Services, a figure known for his skepticism towards vaccines. Shares dipped further on Wednesday, falling 1.4% in premarket trading.

The FDA is currently reviewing Moderna's next-generation COVID-19 vaccine, a component of the combination shot, with a decision expected by the end of the month. Moderna has stated it doesn't anticipate any delays in this decision.

The company had previously pushed back the expected approval timeline for the combined flu-COVID-19 vaccine, designed for adults aged 50 and older, to 2026. Moderna is relying on revenue from newer mRNA shots to offset declining sales of its COVID-19 vaccine and the less-than-anticipated uptake of its respiratory syncytial virus (RSV) vaccine, which contributed to a nearly 60% drop in its stock price last year.

BNN's Perspective: This situation highlights the evolving nature of vaccine development and regulatory processes. While the delay is undoubtedly a setback for Moderna, it also underscores the FDA's commitment to ensuring vaccine efficacy and safety. The market's reaction reflects the financial stakes involved and the impact of public perception on pharmaceutical companies. It's a reminder that the vaccine landscape is dynamic, and companies must adapt to changing scientific understanding and regulatory requirements.

Keywords: Moderna, COVID-19 vaccine, flu vaccine, combination vaccine, FDA, approval, application, withdrawal, resubmission, clinical trials, revenue, stock price, Robert F. Kennedy Jr., mRNA, RSV vaccine, vaccine development, vaccine regulation, pharmaceutical industry, healthcare, health news, vaccine news

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