Thursday, November 21, 2024

AARON SIRI: Flu shots for pregnant women are not licensed by the FDA

Clinical trials are what we rely upon to find whether a product is safe and effective and once there's a clinical trial that's what the FDA would rely upon to then license it for that particular use and so to have a vaccine license for pregnancy women you need to have a clinical trial for pregnant women you'd want to know whether it's safe and effective before promoting it to that demographic.

One would think.  I mean I'm sure that's what every pregnant woman's assuming when they see a poster that says, "The CDC says get your flu shot to protect your baby," they're assuming that's been well tested.

So as you said we FOIA'd the FDA a simple request, "Please provide all the clinical trials relied upon to license the flu shot for pregnant women."  I distinctly remember the phone call with the representative from the FDA who got on the phone with me and tried to say, "You know, we'll just give you all the clinical trials that were used to license the flu shot."  And I said, "Thank you very much, but my client, ICAN, is not requesting all the clinical trials, just those relied upon to license the flu shot for pregnant women.  That's it.  And there was a lot of hemming and hawing.  Weeks, months passed, never got anything, so we decided, okay, time to go to court.  We went to Federal Court.  We sued them, and they finally admitted, "That's right, we don't have any clinical trials because, you know what, it's never been licensed for pregnant women."  That's why, as you just pointed out, when you see a flyer promoting a flu shot for pregnant women, does it say the company's name on it?  No.  Why?  Because that's an off-label use.  It's not a licensed use.  If a pharmaceutical company promoted a flu shot for pregnant women, that would be illegal.

Really?

Yes, because it's not an approved use by the FDA; hence it's an off label use.  Hence, if a pharmaceutical company were to do that, they would be violating federal law.  So who does all the promoting for flu shots for pregnant women?  

The CDC.

Exactly.


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