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# Moderna Withdraws Pending BLA for Flu/Covid Vaccine
- URL: https://www.fdaweb.com/moderna-withdraws-pending-bla-for-flu-covid-vaccine/
- Published: 2025-05-21T12:00:00.000Z
- Updated: 2026-09-14T15:12:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159219

Moderna 5/21 announced that at FDA’s urging, it voluntarily withdrew a pending BLA for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. The company plans to resubmit the BLA later this year, after vaccine efficacy data from the ongoing Phase 3 trial of its investigational seasonal influenza vaccine, mRNA-1010, are available. Interim data from the trial should be available this summer, the company says.

This is another example of the current disruption to vaccine development plans as FDA under the Trump administration crafts new regulatory hurdles for such products. [Earlier this week](https://www.fdaweb.com/novavax-covid-vaccine-approved-after-trial-agreement/), FDA awarded a Novavax BLA traditional approval for its Covid-19 vaccine after the company agreed to an agency-requested postmarketing commitment to conduct a Phase 4 placebo-controlled trial in individuals aged 50 through 64 without high-risk conditions for severe Covid-19\. The BLA review had been delayed since early April as HHS weighed in and required additional data.

On 4/30, an HHS statement said FDA would be requiring all new vaccines to be evaluated in placebo-controlled trials before they’re licensed for use ([see earlier story](https://www.fdaweb.com/placebo-controlled-trials-needed-for-vaccines-hhs/)). And just yesterday (5/20), the agency announced a more targeted regulatory framework for annual Covid-19 booster shots that focuses on protection for high-risk individuals and calling for new clinical trials to evaluate the vaccines’ benefits in healthy Americans ([see story](https://www.fdaweb.com/covid-vaccine-policy-on-boosters-and-new-trials/)).

On 5/1, a Moderna [first quarter financial update](https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-First-Quarter-2025-Financial-Results-and-Provides-Business-Updates/default.aspx?ref=fdaweb.com) noted that the company was “deprioritizing” its flu/COVID combination vaccine based on FDA feedback confirming the need for Phase 3 flu efficacy data. At the time, Moderna had expected an extended review timeline and was targeting approval in 2026.

The Moderna setback comes on the heels of just-reported Phase 3 research that found its combination flu and Covid-19 vaccine demonstrated noninferiority and induced higher immune responses than the recommended standard of care flu and Covid-19 vaccines in adults aged 50 and older. The company [reported](https://jamanetwork.com/journals/jama/fullarticle/2833668?guestAccessKey=143c6ea1-0112-4ea2-8e85-b19e45dd9773&utm%5Fsource=for%5Fthe%5Fmedia&utm%5Fmedium=referral&utm%5Fcampaign=ftm%5Flinks&utm%5Fcontent=tfl&utm%5Fterm=050725) its research in the *Journal of the American Medical Association*.