Moderna says FDA to review its flu vaccine
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By Mariam Sunny and Michael Erman Feb 18 (Reuters) - Moderna said on Wednesday the U.S. Food and Drug Administration changed course and will review its new flu vaccine, a week after rejecting the original submission and fueling drugmaker and investor concerns over policy changes at the agency under the administration of President Donald Trump.
The study involved 550 healthy U.S. adults ages 18 to 75 who received either the experimental combo vaccine and a placebo or two separate shots of Moderna’s commercially available mRNA flu and COVID vaccines, according to a report published in Human Vaccines and Therapeutics.