Pfizer failed to inform pregnant women participating in its clinical trial for the respiratory syncytial virus vaccine that the clinical trial of a similar vaccine by GlaxoSmithKline was halted after a safety signal revealed a potential risk of preterm births leading to neonatal deaths.
Would you risk RSV vaccine side effects on your unborn child for that?
The FDA's VRBPAC committee cleared the shot even though four of the 14 committee memberssaid Pfizer's data was inadequate to support its safety.... Dr. Hana El Sahly, VRBPAC chairwoman, said the signal showing an increased risk of preterm births associated with Pfizer's RSV vaccine was "Significant" in phases two and three of its clinical trial and "In a very similar product that was given, you know, on another study."
The seasonal influenza vaccine was only 48 percent effective overall at reducing the risk of influenza-A-associated emergency department or urgent care visits, and only 40 percent effective at preventing hospitalizations.
Many of my acquaintances say, "Okay, the flu vaccine is not perfect, but I'll take whatever protection it offers, and 50 percent isn't so bad." Well, first of all, "50 percent effective" does not mean 50 percent risk reduction as many lay persons think.
If 2 out of 1,000 in the control group go to the ED due to the flu, and 1 out of 1,000 in the vaccine group go to the ED due to the flu, then the ED visit risk reduction due to the vaccine is 1 - 0.001/0.
Our public health agencies are like an FBI for public health with a monetary incentive.
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