The FDA has agreed to review Moderna’s application for the first mRNA-based flu vaccine after initially declining to do so, following a meeting with the company.
The Food and Drug Administration (FDA) has reversed its earlier decision and will now review Moderna’s application for the first mRNA-based flu vaccine. This change comes after a Type A meeting between Moderna and the agency, where the company proposed full approval for adults aged 50 to 64, as well as accelerated approval for those 65 and older, contingent on additional studies involving seniors.
The FDA has set a target date of August 5 for completing its review, which could allow the vaccine to be available in time for the upcoming flu season. This decision marks a significant step in the development of mRNA technology for flu prevention, a field that has faced scrutiny and skepticism from various quarters.
Critics of mRNA technology, including Robert F. Kennedy Jr. and other officials from the U.S. Department of Health and Human Services, have previously expressed doubts about the efficacy and safety of mRNA vaccines for respiratory viruses. Their concerns have led to the withdrawal of some federal funding related to mRNA vaccine research.
As the FDA prepares to review Moderna’s application, experts from George Washington University (GWU) are available to provide insights into the implications of this decision and the potential impact of mRNA technology on public health. Faculty members include Elizabeth Choma, a pediatric nurse practitioner and clinical assistant professor; Jennifer Walsh, a clinical assistant professor focused on pediatrics and health assessment; and Emily Smith, an associate professor specializing in infectious diseases and epidemiology.
Other experts from GWU include Asefeh Faraz Covelli, an associate professor in the Family Nurse Practitioner program; April Barbour, an internist and associate professor of medicine; and Mia Marcus, an associate clinical professor and primary care provider. Additionally, Maria Portela Martinez, an assistant professor of emergency medicine, and Andrew Meltzer, a professor of emergency medicine and chief of the clinical research section, are also available for commentary.
David Diemert, the clinical director of the GW vaccine research unit, and Jose Lucar, an associate professor of infectious diseases, are among the other faculty members who can provide expert opinions on the evolving landscape of vaccine development. Kelly Gebo, the dean of the GW Milken Institute School of Public Health, brings her expertise as an infectious disease physician and epidemiologist, focusing on disparities in healthcare access and outcomes.
The reopening of the review process for Moderna’s mRNA flu vaccine underscores the ongoing evolution of vaccine technology and its potential role in combating seasonal influenza. As the FDA moves forward with its review, the medical community and the public will be closely watching the developments surrounding this innovative approach to flu vaccination.
For further insights and to schedule interviews with GWU experts, interested parties can contact Katelyn Deckelbaum at katelyn.deckelbaum@gwu.edu.
According to Newswise, this decision could pave the way for a new era in flu prevention.