Moderna withdraws flu-COVID vaccine application amid heightened FDA scrutiny

05/26/2025 / By Ramon Tomey

Moderna withdrew its application for FDA approval of its mRNA-1083 combination vaccine (flu + COVID-19) on May 21, citing plans to resubmit after Phase 3 data for its standalone mRNA-1010 flu vaccine becomes available later in 2024.
The withdrawal follows stricter FDA demands for new clinical trials before approving COVID-19 boosters for healthy individuals under 65, reflecting heightened scrutiny under new Commissioner Dr. Marty Makary.
Moderna’s stock dropped 1.4 percent premarket, adding to a 30 percent decline in 2024 due to falling COVID-19 vaccine sales. The company remains optimistic about FDA approval for its next-gen mRNA-1273 COVID-19 shot by June.
Critics warn of risks from multi-antigen mRNA vaccines (e.g., immune dysregulation), while health advocates urge focus on addressing alleged harms from existing vaccines.
The FDA’s stricter stance aligns with reported plans to halt COVID-19 vaccine recommendations for pregnant women and children, signaling a move toward more rigorous safety evaluations and transparency.

Moderna has withdrawn its application for Food and Drug Administration (FDA) approval of its experimental mRNA-1083 combination vaccine for the flu and Wuhan coronavirus (COVID-19).

The Massachusetts-based drug firm announced the withdrawal on Wednesday, May 21. It added, however, that its application for the two-in-one injection will be resubmitted once Phase 3 trial data for its standalone mRNA-1010 flu vaccine becomes available later this year. mRNA-1010 is one of the two components that make up the combination shot.

The withdrawal came a day after the FDA signaled stricter requirements for COVID-19 booster approvals, reflecting the agency’s heightened scrutiny under new federal health leadership and growing skepticism about the safety and efficacy of multi-antigen vaccines.

Under new FDA Commissioner Dr. Marty Makary, the regulator has demanded new clinical trials before approving annual COVID-19 boosters for healthy individuals under 65. Earlier, the agency limited Novavax’s COVID-19 vaccine to high-risk groups – signaling a shift toward more rigorous safety evaluations. (Related: FDA reconsiders COVID-19 booster approvals, with Makary emphasizing the need for “good data.”)

Nevertheless, the delay has rattled investors – with Moderna’s shares dropping 1.4 percent in premarket trading. This further compounded the company’s 30 percent decline this year amid dwindling COVID-19 vaccine sales.

Prioritize long-term safety over rapid approvals

Moderna President Stephen Hoge downplayed the setback, telling investors that waiting for flu vaccine data was the “most pragmatic approach.” The company still expects FDA approval for its next-generation mRNA-1273 COVID-19 vaccine – another component of the withdrawn mRNA-1083 combination shot – by the end of June.

However, Moderna’s financial outlook remains uncertain. Once a pandemic-era darling, the company has struggled with declining demand for COVID-19 vaccines and underwhelming sales of its respiratory syncytial virus (RSV) shot, leading to a shareholder lawsuit alleging misleading efficacy claims.

The FDA’s stricter stance aligns with broader policy shifts. Reports stated that the Department of Health and Human Services, the FDA’s parent agency, plans to halt COVID-19 vaccine recommendations for pregnant women and children.

GreenMedInfo‘s Sayer Ji called Moderna’s withdrawal “telling,” suggesting it may reflect concerns over “hastily developed, multi-antigen formulations that lack sufficient long-term safety data.” He warned that combination mRNA vaccines introduce poorly understood risks, including potential immune dysregulation and autoimmunity.

Health freedom advocate Dr. Joseph Sansone argued that public health efforts should focus on mitigating alleged harms from existing vaccines rather than accelerating new ones. “Most people you know will have a shortened lifespan due to the COVID injections,” he argued.

As Moderna recalibrates its strategy, the withdrawal underscores a pivotal moment in vaccine policy – one that may prioritize transparency and long-term safety over rapid approvals. Whether this shift stems from scientific caution or political influence remains a topic of debate. But for now, the era of emergency authorizations appears to be waning.

Head over to BigPharmaNews.com for more similar stories.

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