aTm2004 said:

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cone said:

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FDA could have narrowed the label rather than pause it completely

just make it only for able-bodied men. ladies just get the good stuff until the issue is resolved.

ridiculous

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Well, there's quite the pickle with the world we're currently living in.

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either it's an emergency or it's not

cone said:

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question

what proportion of the women in the blood clot group were on the pill?

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This is why they are pausing until the meeting tomorrow to do analysis on these things

emergency meeting tomorrow

i hope lunch is served

once again, when it comes to actual risk, no one is treating this like an emergency

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My goodness how much can we screw up? How illogical can we be?

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13+ months in and you still don't know?

cone said:

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aTm2004 said:

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cone said:

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FDA could have narrowed the label rather than pause it completely

just make it only for able-bodied men. ladies just get the good stuff until the issue is resolved.

ridiculous

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Well, there's quite the pickle with the world we're currently living in.

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either it's an emergency or it's not

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No, I 100% agree that it's an over reaction. I was just pointing out the "fluid" nature of gender, thus your idea would be offensive.

cone said:

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beerad12man said:

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My goodness how much can we screw up? How illogical can we be?

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i'm trying to wrap my head around the logic of extending a EUA to elementary school kids but pulling the J&J vaccine away from public usage based on a tail risk in a very specific cohort who is generally not at high threat to the virus

what a world, man

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There isn't any from where I'm sitting. Maybe there's more we don't know, but I doubt it.

cone said:

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emergency meeting tomorrow

i hope lunch is served

once again, when it comes to actual risk, no one is treating this like an emergency

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Oh I agree and not defended them in the slightest. We'll get more answers to questions like yours soon.

cone said:

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FDA could have narrowed the label rather than pause it completely

just make it only for able-bodied men. ladies just get the good stuff until the issue is resolved.

ridiculous

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Women are more likely to be getting the vaccination but I wonder if men are more likely to get the J&J vaccine because its one-and-done (that was my primary rationale)
https://chicago.suntimes.com/coronavirus/2021/4/12/22380271/covid-vaccination-gender-gap-vaccine-coronavirus

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As of early April, the vaccine breakdown between women and men generally was close to 60% and 40%. States don't measure vaccinations by gender uniformly, though. Some break down the statistics by total vaccine doses, for example, and others report people who have gotten at least one dose.

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There's no reason to halt this if that's all the information we have, unless there's something else going on. And no one should be happy we are slowing down vaccination over such a small, statistically insignificant number.

Again, if you believe this is all there is to it......

So it's not a bad week to pause J&J because there's not any supply anyway, but this is going to kill demand going forward. Just dumb.

We are two bad news stories from being where Europe is and having this all drag on until mid 2022.

beerad12man said:

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There's no reason to halt this if that's all the information we have, unless there's something else going on. And no one should be happy we are slowing down vaccination over such a small, statistically insignificant number.

Again, if you believe this is all there is to it......

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I agree, which leads me to believe there must be more going on than we are being told.

This discussion should be more suited to a Politics Board that fosters even-handed, well-informed, and respectful debate but we obviously don't have that option here. Considering that, it is important to note what we are talking about now is just another chapter in a century long debate over the scope and power of the FDA and their methodologies.

Here is a 1978 quote from Dr. William Wardell of the University of Rochester.

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The implications for the patient are that therapeutic decisions that used to be the preserve of the doctor and the patient are increasingly being made at a national level, by committees of experts, and these committees and the agency for which they are actingthe F.D.A.are highly skewed towards avoiding risks so there's a tendency for us to have drugs that are safer but not to have drugs that are effective.

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The FDA has for forever been an incredibly risk averse institution and has become moreso over time, which has delayed the introduction of all sorts of standard prescriptions ranging from hypertension drugs to RA treatments to depression treatments. These products are almost always adopted in other advanced medical systems around the world years prior to FDA approval.

So this sort of step should not be all that surprising. I was personally wondering if they would even extend the Emergency Use Authorization.

PearlJammin said:

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Infection_Ag11 said:

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Before everyone panics too much, the annual incidence of DVTs in the United States is about 1 per 1000 adults (higher if you look at just women, especially those on birth control).

So 6 cases out of 7 million vaccinated people, especially with all being reproductive age women, is not a particularly striking number and the two are likely unrelated. Worth looking into but the way it's being reported is just more media fear porn without the full context.

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The better question is, why pause a vaccine for this kind of low incidence. Are we getting the full story here? Viagra is more deadly than this.

I got J and J shot on Sunday I felt like crap all of yesterday. I certainly would have chosen something else but this is just ridiculous and will throw gasoline on the fires of doubt.

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I'm thinking along these lines as well. Feels like there is more to this than 6 blood clot cases out of 7 million...we're not getting the entire story if we are using common sense here.

Like...maybe J&J is directing the pause because they don't want to get sued out the wazoo, as this is not a "minor" side effect. Allows them time to find a fix vaccine or pull the vaccine permanently.

CrazyRichAggie said:

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beerad12man said:

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There's no reason to halt this if that's all the information we have, unless there's something else going on. And no one should be happy we are slowing down vaccination over such a small, statistically insignificant number.

Again, if you believe this is all there is to it......

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I agree, which leads me to believe there must be more going on than we are being told.

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Sure, but I'd lean towards political purposes than actual concerns over safety. Maybe pfizer/moderna make more money. This isn't the first time J&J has been delayed. IDK. tin foil on here.

DP

Any idea if this is linked to the previous reports of the "manufacturing issues"?

https://www.politico.com/news/2021/04/01/johnson-johnson-covid-vaccine-478859

For public officials, there is not upside to dealing with risk in this case.

I was scheduled for the J&J today and they cancelled the appointment. Said they deemed the liability too great to administer any and they are being destroyed. Between the storage issue and now this it sounds like J&J put a good dent in the supply.

New England Journal of Medicine has a couple of technical articles outlining what is known about the small number of identified cases.

Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104840


Thrombosis and Thrombocytopenia after ChAdOx1 nCoV-19 Vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2104882


They are referring to this as VITT (Vaccine induced immune thrombotic thrombocytopenia)

So the question is, how many of the 3-3.5 daily supply was J&J? What does this reduce our daily vaccinations to? It changes the timeline in terms of getting all adults at least the chance at vaccination.

Well for this week almost none of it since this is the week that the failed batch is hitting the supply chain.

KidDoc said:

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Those cerebral blood clots are incredibly serious. I can understand the pause especially when there are two other superior vaccines already available under EUA.

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I can't understand the pause with the given numbers

Pause to only last a few days: SIAP

I have said several times we have allowed perfect to be the enemy of good in so many things. And as mentioned earlier, J&J is done regardless if it comes back (Fauci just sealed it's fate with that tweet).

01agtx said:

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beerad12man said:

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There's no reason to halt this if that's all the information we have, unless there's something else going on. And no one should be happy we are slowing down vaccination over such a small, statistically insignificant number.

Again, if you believe this is all there is to it......

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Amen. You'd have to be living under a rock to believe that the FDA is really halting a vaccine due to 6 blood clots out of millions. They're not even trying to make up a good story. I wonder what is really going on.

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The Europeans paused the AstraZeneca vaccine for the same blood clots so I don't think there's a need to go conspiracy theorist here.