The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine after initially declining to consider it.
The decision follows a Type A meeting between Moderna and the agency, during which the company proposed full approval for adults 50–64 and accelerated approval for adults 65 and older, alongside additional studies in seniors. The FDA’s target date for completing its review is August 5, potentially positioning the vaccine for availability ahead of the next flu season.
The reversal comes amid ongoing criticism of mRNA technology from Robert F. Kennedy Jr. and other officials in the U.S. Department of Health and Human Services, who have previously expressed skepticism about mRNA vaccines for respiratory viruses and pulled some related federal funding.
Faculty experts at the George Washington University are available to offer insight. To schedule an interview with an expert, please contact Katelyn Deckelbaum, katelyn.deckelbaum@gwu.edu.
Elizabeth Choma is a pediatric nurse practitioner and clinical assistant professor at the GW School of Nursing.
Jennifer Walsh is a clinical assistant professor in the GW School of Nursing and primarily teaches pediatrics and health assessment.
Emily Smith, is an associate professor of global health and an expert in infectious diseases and epidemiology, at the GW Milken Institute School of Public Health.
Asefeh Faraz Covelli is an associate professor in the Family Nurse Practitioner program at the GW School of Nursing.
April Barbour is an internist with The GW Medical Faculty Associates and an associate professor of medicine at the GW School of Medicine and Health Sciences.
Mia Marcus is an associate clinical professor at the GW School of Medicine & Health Sciences and a primary care provider at Medical Faculty Associates.
Maria Portela Martinez is an assistant professor of emergency medicine at the GW School of Medicine & Health Science and a family medicine physician.
Andrew Meltzer is a professor of emergency medicine and the chief of the clinical research section at the GW School of Medicine and Health Sciences.
David Diemert is the clinical director of the GW vaccine research unit and professor of medicine at the GW School of Medicine and Health Sciences.
Jose Lucar is an associate professor of infectious diseases at the GW School of Medicine and Health Sciences.
Kelly Gebo is the dean of the GW Milken Institute School of Public Health. An infectious disease physician and epidemiologist, Dr. Gebo’s research has focused on disparities in access to care and outcomes among people affected by HIV, COVID-19, and other infectious diseases.
Source Credit: https://www.newswise.com/articles/fda-reopens-review-of-moderna-s-mrna-flu-shot
