Moderna Inc. said it has “voluntarily” withdrawn its application for regulatory approval for its combination Covid and flu shot for people 50 and over, a setback for the company. The biotech company said it made the decision after consulting with the Food and Drug Administration. It plans to resubmit the application later this year after getting more data from a late-stage trial of its standalone flu vaccine, it said in a statement Wednesday.

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. The news comes a day after the US Food and Drug Administration announced that seasonal COVID-19 boosters would now be recommended only for adults ages 65 and older or for those who are at risk for severe COVID-19 because of underlying health conditions. Moderna's combination vaccine was intended for adults 50 and older.

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate for adults aged 50 years and older. The company would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine, it said. Moderna expects interim data from the trial to become available this summer. The company'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 years.

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Moderna MRNA.O said on Wednesday it had withdrawn the pending application for its flu and COVID combination va