Moderna has withdrawn its application seeking approval for a flu and COVID-19 combination jab. “Moderna, Inc., today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older,” the company said. “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. Moderna continues to expect interim data from the mRNA-1010 trial to be available this summer,” it added. 1 down, 499 to go. pic.twitter.com/t3s8AfvHMD — Mary Talley Bowden MD (@MdBreathe) May 21, 2025 Per Reuters: Its shares, which have fallen over 30% this year, were marginally higher at $24.20 in premarket trading. However, the application withdrawal is the latest sign of increased regulatory scrutiny of the vaccine approval process since Robert F. Kennedy Jr. took the top U.S. health job earlier this year. Moderna’s decision comes a day after the U.S. Food and Drug Administration said it would require new clinical trials for approval of annual COVID-19 boosters for healthy people under 65. The combination shot comprises a new COVID vaccine and an influenza vaccine, both under development by Moderna. The company has previously said it does not expect a delay in the FDA’s decision for the next-generation COVID vaccine, which is due by the end of the month. JUST IN: "Today vaccine maker Moderna announced it voluntarily pulled its licensing submission for the combination seasonal influenza–COVID-19 mRNA vaccine candidate, mRNA-1083, so that it can submit efficacy data." pic.twitter.com/VRTPEcey8C — Children’s Health Defense (@ChildrensHD) May 21, 2025 The Guardian reports: Moderna in early May pushed back the time frame for likely approval of its combination vaccine – meant to protect adults aged 50 and above against both Covid-19 and influenza – to 2026. The company has been banking on revenue from newer mRNA shots to make up for falling sales of its Covid vaccine and less-than-expected uptake of its respiratory syncytial virus vaccine, which sent its shares down nearly 60% last year. The announcement follows the FDA telling Pfizer and Moderna to expand the warning labels of their mRNA COVID-19 jabs about the risk of heart complications. According to an interim report from Sen. Ron Johnson’s office, CDC and FDA officials knew in 2021 about the potential risks of heart-related complications, such as myocarditis, from the experimental COVID-19 jabs and hid the knowledge from the public for months. Senate Report Alleges Biden Administration Health Officials Hid COVID-19 Jab Risks From Public For Months