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.
