When the Food and Drug Administration approved Moderna's mRNA flu vaccine, the first ever, two weeks ago, the pharmaceutical company that reaped billions from federal taxpayers with its mRNA COVID-19 vaccine didn't wait for the agency to even publicly post the approval. Moderna rushed out the news at 10 p.m., with a 4% increase in its share price the next morning.

It was a promising market signal for a drugmaker whose revenue cratered following the collapse in demand for COVID vaccines, which also led Pfizer to cancel a trial this spring for its own updated mRNA COVID jab. 

What Moderna left out of the release Wednesday, and the media ignored: the mRNA flu jab's disproportionately high rate of serious adverse events compared to a normal flu shot – the same problem with its Omicron-specific COVID vaccine three years ago – and the number of jabs required to prevent a single hospitalization, 5,000.

Yet the market and the media went crazy for Moderna this week when it announced "positive topline results" from a late-stage trial of its cancer vaccine with Merck, with a 177% spike in its share price on top of a 357% increase this year before the cancer vaccine news, despite no published trial data or FDA approval. 

The jargon-laden press release said the melanoma trial met its primary and secondary endpoints: "recurrence-free survival" and "distant metastasis-free survival." 

What it obscured: Taken with Merck's cancer therapy Keytruda following removal of cancerous tumors, the treatment – technically not a "vaccine" – lengthened cancer patients' lives and halted their cancer's progress for an unspecified period of time.

The company has laid out a potential media-tested roadmap for other drugmakers, at least those working with mRNA technology: A glowing but vague press release is enough to juice their coffers and create demand for as-yet unapproved products with unknown risk profiles.

'Essential' to WHO and stockpiled by governments without a rigorous trial 

Some doctors are asking why Moderna gets a pass from scrutiny by withholding data while juicing its share price. (Moderna has promised its cancer vaccine data will be "presented at an upcoming international medical meeting and shared with regulatory authorities.")

Data from its "pivotal clinical trial" for the recently approved mRNA flu vaccine is still missing from the National Institutes of Health's ClinicalTrials.gov, FDA adviser Retsef Levi, whose 2022 peer-reviewed study found COVID vaccination "significantly associated" with emergency heart problems in young Israelis, wrote on X.

"Is it not mandated?" he asked, tagging Director Jay Bhattacharya and Health and Human Services Secretary Robert  F. Kennedy Jr. "How come the data from the major trial used for approval [is] not publicly reported?" Robert Malone, the mRNA pioneer, deadpanned "Rules for thee but not for me."

The scrutiny of the hidden flu trial data comes as a new randomized trial of Roche's $18 billion flu antiviral Tamiflu (oseltamivir) suggests it's harmful to the most vulnerable patients, with fatality rates around 20% for those who took it for 5-10 days and 14% for the control group. 

Not yet peer-reviewed, the study is the first to compare Tamiflu to "no antiviral treatment in a randomized trial of critically ill patients with influenza," Harvard Med professor Paul Sax wrote in New England Journal of Medicine Voices this week. 

"We somehow reached a point where a drug was routinely given, endorsed by guidelines, placed on the World Health Organization’s Essential Medicines List specifically for severe influenza, and stockpiled by governments – all without that trial ever having been done," Sax wrote. 

Former New York Times drug industry journalist Alex Berenson, who flagged the Tamiflu trial, previously noted the perils of hyping a treatment without a rigorous trial, judging by a gonorrhea vaccine study in NEJM this summer.

The randomized placebo-controlled trial of men who have sex with men, following supposedly positive observational studies, found the vaccine didn't benefit the treatment group but seriously hurt some of them. 

"Not one mainstream American news outlet reported the vaccine’s failure" and England is "so far still recommending it despite the new results," Berenson wrote.

Played the 'medical-scientific establishment like a Stradivarius'

"Seeing numerous doctors and scientists hail this [Moderna cancer] 'breakthrough,'" Joseph Marine, vice director for operations in Johns Hopkins Hospital's cardiology division, wrote on X, explaining how "pharma companies manipulate the US health system" into paying the "highest drug prices in the world, even for many products that produce minimal real-world results."

"Press release amplified by 'thought leaders' produces media feeding frenzy and huge pop in stock price," he wrote. "Public and market expectations are now permanently anchored into 'breakthrough miracle cure.' Even if published trial results are much more modest [...] the public will demand that government and insurance companies pay" the "astronomical" prices.

"These corporations have learned how to play the medical-scientific establishment like a Stradivarius," Marine mused about Moderna and its peers.

"No data presented, no paper published – but apparently the stock market has already completed peer review," Charlotte Kupperwasser, cancer biology professor at Tufts Medical School, wrote on X. 

By contrast, Levi's paper with former FDA drug evaluation chief Tracy Beth Hoeg on "observed-to-expected fetal losses" from COVID vaccines remains in "pre-print purgatory because of journal gatekeeping," Kupperwasser said earlier this month, relating it to her writing on gatekeepering in "early warning signals" for cancer.

She elaborated to Just the News that the five journals that received the fetal-losses preprint, now more than a year old, have "rejected it without external peer review" and without transparent explanations.

"Show us some actual data," canceled doctor and medical freedom activist Mary Talley Bowden responded to Moderna's news. 

"Remember that press release when you told us [the] Covid-19 vaccine was 94.5% effective in preventing transmission?" she said, referring to Moderna's uncritically touted but widely misunderstood Phase 3 results for its original COVID vaccine, based on relative risk reduction from a negligible rate of symptomatic infection for both jabbed and control groups.

Faced with critical questions about the vague results in the Merck trial after touting his "superstar" wife, Merck Vice President of Oncology Jane Healy, sportswriter Luke Epplin simply responded to critics, "Isn't my wife awesome?"