FDA advisory panel unanimously recommends Moderna's mRNA flu vaccine for older adults
By
Chris Dall, MA
Summary
A federal vaccine advisory panel (FDA's VRBPAC) unanimously voted to recommend approval of Moderna's mRNA influenza vaccine (mRNA-1010, brand name mFlusiva) for adults aged 50-64, and supported accelerated approval for adults 65 and older. Moderna will need to conduct a phase 4 post-marketing study to demonstrate effectiveness.
Source
bskyFDA advisory panel unanimously recommends Moderna's mRNA flu vaccine for older adultscidrap.umn.eduKey quotes
· 2 pulledBy a unanimous vote, the Food and Drug Administration's (FDA's) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend approval of the investigational vaccine
Moderna will be required to conduct a phase 4, post-marketing study to demonstrate effective
You might also wanna read
FDA advisory panel unanimously votes to approve Moderna's mRNA flu vaccine after Trump appointee tried to block review
FDA independent advisors voted 9-0 to recommend approval of Moderna's mRNA seasonal flu vaccine (mRNA-1010), despite a Trump appointee at th
arstechnica.com·1d ago
FDA Issues Refusal-to-File Letter to Moderna for mRNA Influenza Vaccine
The article criticizes the FDA's recent actions under the new administration, particularly focusing on a Refusal-to-File (RTF) letter issued
marginalrevolution.com·4mo ago
Personalized mRNA Cancer Vaccine Shows 49% Risk Reduction at 5-Year Follow-up
Moderna and Merck report promising 5-year follow-up results for their personalized mRNA cancer vaccine combined with Keytruda immunotherapy.
arstechnica.com·4mo ago
Moderna's Post-Pandemic Crisis: From Vaccine Success to Corporate Challenges
The article examines Moderna's current crisis despite its success with the COVID-19 vaccine. After achieving a 95% effective vaccine and mas
statnews.com·7mo ago
HPV Vaccine at 20: Proven Cancer Prevention Tool Faces Uptake Challenges
The article marks the 20th anniversary of the FDA's approval of the first HPV vaccine in 2006, highlighting its evolution from a quadrivalen
mdsc.pe·4d ago
HHS Ends mRNA Vaccine Development Under BARDA Following Review
The U.S. Department of Health and Human Services (HHS) has announced the wind-down of its mRNA vaccine development activities under BARDA, i
hhs.gov·10mo agoComments
Sign in to join the conversation.
No comments yet. Be the first.