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AltFDA

14 Apr, 13 tweets, 5 min read

@DataDrivenMD

Afternoon peeps. I was asked by @DataDrivenMD to provide some FDA context to his thread on the #JohnsonandJohnson vaccine pause. #Thread 🧵

https://twitter.com/DataDrivenMD/status/1382008748697219073

I’m going to start this thread by asking you to think back way beyond what you had for breakfast. All the way back to me bitching about low trial size.

My concern then was that we did not have enough ppl enrolled to truly find the weird stuff (J&J had their EUA based on 22k trial participants).

Fast forward to today!

We have finally reached enough ppl in the vaccine trial to find the weird stuff.

And YES, we/ you are still in a trial. Until the FDA gives full approval for this and the other vaccines, your data and outcomes are being used as trial data to get the full authorization.

Understood? Good?

So why the pause?

The pause is due to 3 unique factors.

Factor 1: Women of child bearing age.

Factor 2: Low blood platelets.

Factor 3: Cerebral (brain) blood clots.

Now factors 1 & 3 are not the trigger in this investigation (pause), factor 2 is the attention grabbing data point.

That is not a “common” medical condition. Here is a Mayo Clinic article on it. mayoclinic.org/diseases-condi…

So, what is the FDA going to look at?

The FDA is looking at the medical history of each of these cases. They are looking for similarities between them. Did they all have cancer? Do they all just have this condition (low platelet count)? Etc...

What’s the outcome will be from this you might ask?

The greatest thing the FDA does, issue a NEW GUIDANCE!

And this is a good news item you are going to read here first. The guidance will protect you, not slow down dosing and keep the vaccine on the market for those that like it to use.

The guidance will address the dosing of the vaccine. It will likely request an extra screening for ppl in the small group this issue (low blood platelets) affects. It may also exclude these ppl from this vaccine. The guidance will be based on what they find during this pause.

@DrWoodcockFDA

The good news is, the vaccine is safe and now it’s safer because we found a subset of the population that might have an Adverse Effect after receiving it. This is what the FDA does even though they often explain it poorly. @DrWoodcockFDA

@jeremyfaust

Adding this thread to my thread for extra thread-eddy-ness thanks @jeremyfaust

https://twitter.com/jeremyfaust/status/1382536833863651330

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@KatherineEban

#Thredjacking I hope you don’t mind @KatherineEban.

I am seriously sick of this reactionary well poisoning! #Thread 🧵

https://twitter.com/katherineeban/status/1381974250895126531

@angie_rasmussen

Right here is the stats on the current irrational fear over blood clots. Thank you @angie_rasmussen for this.

For more context:

Being hit by lightening: 1/ 500,000

Being hit by a car 1/ 5,000

You still walk in the rain and drive places.

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@AstraZeneca

It’s Tuesday and that means tacos & talking shit. For today’s #Thread 🧵, I’m going to go full cable show talking head on the @AstraZeneca vaccine. (This is a complete opinion thread but you better bookmark it. I have a feeling I’m spot on in my analysis.)

Yesterday, it was all over the news that #AstraZeneca was going to release its trial data and that it looked “GREAT!”. And by great that meant on a 2 shot vaccine it protected 100% against death and sever hospitalization and had a ~79% efficacy rate (Which is just above J&J).

For contrast the J&J is ~75% effective on one dose with the same 100% prevention of death and hospitalization. On the face of it, you think they are the same.

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To the #science we talked about this morning that will apply to educators. #Thread 🧵

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We now have the data to support that viewpoint. The data : jamanetwork.com/journals/jamap…

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This Monday, I got word my vaccine was pushed back a month and I’m pissed! A #Thread 🧵on how OWS has fucked us all.

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... state in 36 hours. Within 48 hours we could be dosing the million ppl a day @JoeBiden is asking for.

And forgive me but this thread is going to get long and go deep in some weeds.

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14 Dec 20

Last night I got a text saying “Talk to me about the vaccine”

Here’s how I responded... #Thread 🧵

(For a frame of reference, this is a friend with a masters of education.)

D (Dallas)- The vaccine is good, I’ve read the trial protocol and the efficacy paper.

F (friend)- So what do you think?

D- I’ve got my spot in line to get it, I’m getting it.

D- The vaccine is going to generate a have and have nots in our society. Not getting it will hurt your lively hood.

F- What about its safety? Long term side effects?

D- Most side effects are diagnosed within the first 2 months of a full dose. We are 3 months in.