Seems drug trials are an inconvenience.
Two weeks ago Moderna pushed out a news release on it’s mRNA flu vaccine that shot its stock price up 4% the next morning. Only problem was, the FDA had yet to announce approval.
While the rising stock is impressive, the shot is a different story. Someone forgot to tell the public it takes 5,000 jabs to prevent 1 hospitalization above the old flu vaccine’s performance, but at a severe cost. The mRNA flu shot has 6.4X the adverse effects of the old vaccine.
Now Moderna takes it a step further.
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.
Meanwhile the trial is in ‘hiding’
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.
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