Moderna has announced FDA approval of a novel mRNA flu “vaccine.”
Whereas traditional flu vaccines rely on isolated viral proteins grown in chicken eggs — the conventional method of vaccine production — Moderna’s new product, like its COVID vaccine, contains synthetic mRNA that triggers the production of hemagglutinin (HA) viral proteins, which in turn theoretically safely trigger an immune response to future encounters with actual flu viruses in the environment.
Related: Moderna Withheld Data From FDA Regulators to Get Bivalent Booster Approved
The flu shot and the COVID/flu shot combination are together estimated to generate three-quarters of a billion dollars in revenue by 2030.
Via Reuters (emphasis added):
The U.S. Food and Drug Administration has approved Moderna's (MRNA.O) flu vaccine for people aged 50 and older, the company said on Wednesday, marking the first approval of a messenger RNA-based vaccine for seasonal flu.
The shot, mFlusiva, was given a traditional approval for adults aged 50 to 64, and an accelerated approval for those 65 years and older…
Moderna has agreed to run an additional study and submit more data in adults 65 and older to confirm the vaccine's benefit in that age group…
The approval was based on data from a late-stage trial involving more than 40,000 adults aged 50 and older, which showed the shot was 26.6% more effective than a licensed standard-dose flu vaccine.
The company also submitted separate late-stage data showing the vaccine generated stronger antibody responses than Sanofi's high-dose flu vaccine in adults 65 and older.
MFlusiva would compete with flu vaccines from Sanofi (SASY.PA),, GSK (GSK.L), CSL Seqirus (CSL.AX),, and AstraZeneca (AZN.L)…
Jefferies analysts had forecast $750 million in U.S. sales of Moderna's flu shot and combination COVID-flu vaccine by 2030.
Related: Making a Killing: Americans Shelling Out up to $190 for COVID Boosters
From Moderna’s press release, via Newswire (emphasis added):
“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," said Stéphane Bancel, Chief Executive Officer of Moderna. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible."…
Moderna expects to have mFLUSIVA available for eligible populations in the U.S. for the 2026-2027 respiratory virus season, alongside Spikevax® (COVID-19 Vaccine, mRNA), mRESVIA® (Respiratory Syncytial Virus Vaccine) and mNEXSPIKE® (COVID-19 Vaccine, mRNA).
Manifest safety concerns of mRNA platforms aside, while hyped as a breakthrough by the company and legacy corporate state media dependent on pharmaceutical industry advertising, Moderna’s novel mRNA “vaccine” doesn’t solve the essential problem of the constant mutation of the influenza virus, specifically in the Hemagglutinin (HA) glycoprotein that facilitates the binding to human cells, which means that the protection won’t last and will require ongoing yearly (or more frequent) shots to maintain its already-paltry 27% increase in efficacy compared to current flu shots.
Editor's Note: Do you enjoy PJ Media's conservative reporting that takes on the radical Left and woke media? Support our work so that we can continue to bring you the truth.
Join PJ Media VIP and use promo code FIGHT to receive 60% off your membership.
Join the conversation as a VIP Member