The Food and Drug Administration approves mFlusiva mRNA influenza vaccine for adults aged 50 and older
The Food and Drug Administration approved mFlusiva, an mRNA influenza vaccine, for adults aged 50 to 64 and adults 65 and older. The approval was granted after the FLUENT trial demonstrated that mFlusiva provided 26.6% higher relative vaccine efficacy compared to a standard-dose inactivated influenza vaccine for adults 50 and older.
Show the rest of this summary
The trial enrolled more than 40,000 adults and showed that mFlusiva met the Food and Drug Administration's superiority threshold. While the vaccine's safety profile was consistent with previous influenza vaccines, mFlusiva produced higher rates of injection site pain, fatigue, headache, and myalgia compared to the standard-dose vaccine. These symptoms are expected and generally short-lived. hought<channel|>```json, {
Sources
-
mFlusiva becomes the first mRNA influenza vaccine approved by the FDA
2 Minute Medicine
-
GSK Advances mRNA Flu Vaccine Candidate to Phase 3 After Positive Phase 2 Data
BioPharm International
Paywall and unreadable sources
-
GSK plans phase 3 after mRNA flu vaccine beats standard shots
Fierce Biotech
-
GSK to launch Phase 3 test of mRNA flu vaccine with newer formulation
Endpoints News
-
GSK: Still One Of My Top Healthcare Picks
Seeking Alpha