FDA approves new mRNA vaccine, despite risks
F.D.A. Approves Moderna’s mRNA Flu VaccinemFLUSIVA is the first FDA-approved mRNA influenza vaccine.
Food and Drug Administration
Wednesday 5th August approved the first mRNA flu vaccine
Will make it easier to rapidly target a new prevalent or virulent strain of the virus.
mFLUSIVA
Manufactured by Moderna
https://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNA&utm_source=chatgpt.com
"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform,"
This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.
mFLUSIVA
Authorized for people ages 50 to 64.
Primary FDA references
https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-18-2026-meeting-announcement?utm_source=chatgpt.com
https://www.fda.gov/media/193210/download?utm_source=chatgpt.com
The F.D.A. issued an accelerated approval for adults 65 and older,
(allows widespread use and can be converted to a full approval)
Moderna expects vaccine ready for 2026-27 respiratory virus season.
Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults
https://www.nejm.org/doi/full/10.1056/NEJMoa2516491
Encodes hemagglutinin glycoproteins from World Health Organization–recommended influenza strains.
H is the surface protein used to attach to human cells
The name "hemagglutinin" comes from the proteins ability to cause erythrocytes to clump together
The study
A total of 40,703 participants.
received trivalent mRNA-1010 (20,350 participants)
or the standard-dose comparator (20,353 participants)
Median follow-up was 181 days
RT-PCR–confirmed, influenza-like illness,
from at least 14 days after vaccination
mRNA-1010 group
Positive in 411 of 20,179 recipients
(2.0%)
Control group
Positive in 557 of 20,124 recipients
(2.8%)
Giving a relative vaccine efficacy of 26.6%
0.8% absolute risk reduction
thereby meeting the criteria for noninferiority, superiority, and higher-level superiority.
Solicited adverse reactions were more frequent with mRNA-1010 than with the standard-dose comparator
injection-site pain in 65.8% vs. 29.8%
fatigue in 45.1% vs. 20.3%
headache in 37.8% vs. 18.0%
myalgia in 35.4% vs. 11.6%
Serious adverse events were reported in 2.2% of the recipients of mRNA-1010
Grade 3 solicited adverse reactions were reported by 6.4% of recipients of mRNA-1010 and 1.0% of recipients of the standard-dose comparator
Adverse events of special interest in recipients of mRNA-1010 included thrombocytopenia 84 days after vaccination and cardiomyopathy 95 days after vaccination
Despite efforts by HHS (Health and Human Services)
https://www.hhs.gov/press-room/hhs-winds-down-mrna-development-under-barda.html
August, 2025
Secretary Robert F. Kennedy announced a coordinated wind-down of its mRNA vaccine development activities under the Biomedical Advanced Research and Development Authority (BARDA)
“We reviewed the science, listened to the experts, and acted,”
“BARDA is terminating 22 mRNA vaccine development investments because the data show these vaccines fail to protect effectively against upper respiratory infections like COVID and flu.
https://zenodo.org/records/15787612
We’re shifting that funding toward safer, broader vaccine platforms that remain effective even as viruses mutate.”
“Let me be absolutely clear: HHS supports safe, effective vaccines for every American who wants them. That’s why we’re moving beyond the limitations of mRNA and investing in better solutions,”
News refs
https://www.nytimes.com/2026/08/05/health/mrna-flu-vaccine-moderna.html?unlocked_article_code=1.3VA.BfR8.KWHKEmThIMBp&smid=nytcore-ios-share
https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-first-mrna-flu-shot-moderna-2026-08-06/?utm_source=chatgpt.com Receive SMS online on sms24.me
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