How can Moderna's RSV jab be approvable?
The company's own trial shows its shot caused 200 side effects (10 severe) for each RSV infection it stopped. You read that right: 200 to 1. RSV is a cold for most adults. Will regulators step up?
As demand for its mRNA Covid shot craters, Moderna is chasing approval for a new mRNA jab with similarly severe side effects - but against a virus even milder than Covid.
Winning approval for the jab, which reduces cases of respiratory syncytial virus, or RSV, is critical for Moderna’s future. The company has told investors RSV shots could make $10 billion a year.
The only problem: data from Moderna’s own pivotal clinical trial for its RSV shot. The trial showed the new jab causes hundreds of side effects - including 10 cases of severe side effects - for each RSV infection it prevents.
If RSV were very dangerous, that side-effect profile might make sense.
But it isn’t. The Centers for Disease Control reports that RSV usually causes “mild, cold-like symptoms.”
As it pursues approval, Moderna has vastly overestimated RSV’s lethality. A review of death certificates found that RSV kills about 35 American adults a year - about as many as die in lightning strikes, and one four-hundredth as many as Moderna has claimed. (Yes, you read that right; Moderna has overstated adult deaths from RSV by a factor of 400. Proof below.)
When Moderna applied for authorization for its Covid mRNA jab in 2020, the world was so desperate to beat the coronavirus that regulators ignored obvious red flags about side effects.
Three years later, will they make the same mistake twice?
(THE ANSWER, OR AT LEAST MORE QUESTIONS, BELOW.)
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