Return of the rubber stamp? First mRNA flu vaccine has far higher injury rate than standard jabs

The Senate Permanent Committee on Investigations exposed COVID-19 vaccine injuries long "masked" in government surveillance databases, allegedly at the behest of the Biden administration. Thanks to the Trump administration's drug regulators, the panel led by Sen. Ron Johnson, R-Wis., has a new opportunity to investigate vaccine safety.

Moderna announced late Wednesday that the Food and Drug Administration approved its mRNA flu vaccine, the first ever, despite the drugmaker purportedly refusing to test it against a placebo and its own research finding little benefit over a standard licensed flu shot and a worse safety profile. One pharmacologist called the results "not breathtaking." 

MFlusiva, as Moderna calls the new product, requires 5,000 jabs to prevent one additional hospitalization over the old technology, based on an absolute difference of four hospitalizations between matched groups of 20,000 patients. Its rate of severe adverse reactions – "Grade 3" – is 6.4%, compared to 1% for an old flu shot.

The company's Omicron-specific COVID vaccine three years ago also had an unusually high rate of Grade 3 events, 25%, which the National Institutes of Health defines as "incapacitating; unable to perform usual activities; requires absenteeism or bed rest."

The formal approval didn't appear on the FDA website until late afternoon Thursday – Just the News checked throughout the day – with every media and industry report citing Moderna's 10 p.m. Wednesday announcement.

It authorizes mFlusiva under two indications, the first for ages 50 and up and the second under accelerated approval for ages 65 and up. The latter requires Moderna to conduct a "postmarketing" randomized study to evaluate mFlusiva's relative effectiveness versus a high-dose flu vaccine, which the FDA had asked Moderna to use from the start.

The FDA didn't answer a query through its media portal to explain why it approved the mRNA jab despite the mediocre trial results.

The agency acknowledged the higher rate of serious injury from mFlusiva in its briefing document for the Vaccines and Related Biological Products Advisory Committee in June, but said the injuries were "predominantly mild to moderate in severity" and emphasized no association with heart inflammation – a chronic problem with mRNA COVID vaccines.

However, FDA staff was not thrilled with the breadth of evidence Moderna provided, Pharma Exec reported at the time. The trial was limited to the circulating strains in a single flu season and the vaccine was not studied in "immunocompromised patients or very frail older adults," the groups most at risk from both flu- and mRNA-related complications.

Though the mRNA jab showed 26.6% "relative efficacy" versus the old shot for confirmed "influenza-like illness," and 47.9% for "higher-level care (hospitalization, emergency department, or urgent care)," Moderna didn't try to oversell mFlusiva's safety profile, simply calling it "acceptable" in Wednesday night's press release.

The approval comes six months after then-Center for Biologics Evaluation and Research Director Vinay Prasad refused to review Moderna's biologics license application based on "substandard' trial design — Prasad's specialty as an epidemiologist — by not using a high-dose comparator for ages 65 and up.

Massachusetts-based Moderna, which made billions off federal taxpayers with its mRNA COVID vaccine, responded by threatening to take jobs abroad. The FDA agreed to review the BLA a week later, after Moderna agreed to meet the agency's previously stated requirements.

Some reporting based only on Moderna's press release Wednesday night stated the FDA had "rejected" the mRNA vaccine application and then "reversed" its decision.

FDA regulatory review officer Jessica Adams disputed that reporting in an X post Thursday.

"STOP SAYING THE FDA “REJECTED” THE MRNA FLU VACCINE AND THEN “REVERSED” IT. THERE WAS A FILING-LEVEL REJECTION OF THE ORIGINAL APPLICATION FOR TRADITIONAL APPROVAL IN ADULTS 50+. THAT IS NOT A FINAL REJECTION OF APPROVAL. IT WAS RESOLVED BY AMENDING TO A SPLIT PATHWAY. NOT A REVERSAL," she wrote in President Trump-style all caps.

In another post Thursday, she said a claim that the FDA initially refused Moderna’s mRNA flu vaccine because it didn’t use a true placebo was "not accurate."

The FDA rejected Moderna's use of a "standard-dose flu vaccine as the comparator across that entire group" of elderly adults, "for whom high-dose or adjuvanted vaccines are preferentially recommended," Adams also wrote on X. "It was not a final rejection of approval, and it was not about lacking a saline placebo."

With Prasad's exit in April and his patron, FDA Commissioner Marty Makary, the next month, the FDA lost its two biggest boosters for higher drug approval standards. It had made them the target of factually challenged whisper campaigns laundered through the media, including a false sexual harassment claim The Wall Street Journal took three weeks to correct.

The approval of mFlusiva shows "Pharma finished recapturing" the FDA, former New York Times drug industry reporter Alex Berenson wrote in his newsletter. "There was no chance the FDA would say no to this jab" once the administration reportedly forced Prasad's resignation. (Makary said Prasad's one-year commitment had ended.)

Berenson had initially flagged the mRNA vaccine's "comically bad risk-benefit ratio," ignored by the mainstream media, when Moderna published trial results in the New England Journal of Medicine. Had it tested the jab against a placebo, the side effect profile would probably be "even worse," he said.

The Senate confirmation of Erica Schwartz as Centers for Disease Control and Prevention director, its first permanent leader in nearly a year, also suggests a return to the old guard in public health agencies ahead of midterm elections.

All but three Republicans voted for Schwartz despite her role in threatening to have service members prosecuted for refusing vaccine mandates in the first Trump administration, while only one Democrat voted for her, apparently irking the others because of her refusal to pledge resistance to any moves against vaccine availability or confidence.

Two Republicans simply voted "absent," vaccine safety inquisitor Johnson and retiring Sen. Thom Tillis, R-N.C., while Sen. Mitch McConnell, R-Ky., is away on medical leave.

The first Senate-confirmed director, establishment favorite Susan Monarez, didn't last long due to trust issues with Health and Human Services Secretary Robert F. Kennedy Jr.