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FDA Declines to Review Modernas mRNA-1010 Flu Vaccine Application, Citing Comparator Concerns The FDAs Center for Biologics Evaluation and Research (CBER) has declined to review Modernas biologics license application (BLA) for its investigational influenza vaccine, mRNA-1010, and issued a refusal-to-file (RTF) letter, according to an announcement released by the company
It has demonstrated oral stability in gastric juice and efficacy even at microgram or nanogram doses
Jama 2022;327:138-50
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