US biotechnology company Moderna Inc (Nasdaq:MRNA) announced on Wednesday that it has voluntarily withdrawn its Biologics License Application for mRNA-1083, a combination vaccine targeting influenza and COVID-19 in adults aged 50 and older.

This decision was made in consultation with the US Food and Drug Administration (FDA), Moderna said.

The company plans to resubmit the application later in 2025, following the release of vaccine efficacy data from its ongoing Phase 3 trial of mRNA-1010, an investigational seasonal influenza vaccine. Interim results from the mRNA-1010 trial are expected this summer.

The withdrawal aligns with Moderna's earlier projection that approval for the combination vaccine will not occur before 2026. The regulatory delay reflects a broader shift in oversight, following the appointment of Robert F. Kennedy Jr. to lead the US Department of Health and Human Services.

On 20 May, the FDA announced that new clinical trials would be required for annual COVID-19 boosters in healthy individuals under 65.

Moderna's combination vaccine includes both a new COVID-19 component and a novel flu vaccine, both still in development.