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US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

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Re: US agencies call for pause in Johnson & Johnson vaccine

#321

Post by Pyramus »

base698 wrote: post #301
UncleOxidant wrote: post #291

Earlier quoted context omitted.

Whenever you catch a cold or flu those are generally DNA viruses (unless it's a coronavirus cold). Those don't alter your DNA.

Eh, yeah they do. We have tons of base pair sequences in our DNA that we suspect came from viruses. https://newsroom.uw.edu/news/genes-%E2%80%98fossil%E2%80%99-...

Parent specifically stated DNA viruses. From your article:

> Most of these viral genes come from retroviruses, RNA viruses that insert DNA copies of their own genes into our genomes when they infect cells. HHV-6 is unique because it is the only known human DNA herpesvirus that integrates into the human genome and can be routinely inherited.

Re: US agencies call for pause in Johnson & Johnson vaccine

#322

Post by textman »

"The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence." https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...

So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J vaccine 12 days ago. No noticeable side effects so far. I exercise a lot and did a 5 mile hike four days ago that resulted in a slightly strained a calf muscle. I have been taking it easy the past few days, meaning sitting and reading a lot more than usual. So after learning about the blood clotting, have started exercising the legs frequently. My optimistic thinking is that even if the vaccine does cause an increased risk of CVST that risk can be eliminated via exercise.

It will be most interesting to learn if those six cases involved people at high risk, if they exercise regularly, etc.

Re: US agencies call for pause in Johnson & Johnson vaccine

#323

Post by jdminhbg »

peytn wrote: post #303
jdminhbg wrote: post #284

Earlier quoted context omitted.

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.

We've changed the rules for every single part of life and society because of this massive emergency, with no idea what the long-term consequences of doing so might be. I'm not sure why the FDA should be excluded.

Re: US agencies call for pause in Johnson & Johnson vaccine

#324

Post by jjk166 »

sjg007 wrote: post #22

Why are women adversely affected?

CVST normally affects women at significantly higher rates than men.

> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]

[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....

Re: US agencies call for pause in Johnson & Johnson vaccine

#325

Post by Nokinside »

jdhn wrote: post #68

Here's a question for someone smarter than me. Is there a chance that this number (six cases in seven million doses) will rise as regulators comb through previous reports of adverse effects?

Not an expert in but one of those expert drug regulators is my friend.

1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is.

When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 hours per day 7 days a week with a team going through a massive amount of data and documentation to verify and check everything.

The media and most commentators don't understand why decisions can take weeks. Why you don't have the scheduled emergency approval meeting just now. They fail to understand that fact-finding is not happening in the meeting just by people giving their expert opinions. Experts work around the clock without taking any time off to figure out what is happening. But lazy bureaucratic regulators, right?

Re: US agencies call for pause in Johnson & Johnson vaccine

#326

Post by __s »

peytn wrote: post #303
jdminhbg wrote: post #284

Earlier quoted context omitted.

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.

Our current rules are what was done. You're the one advocating for more cautious rules because you consider 1 in a million side effects too great a cost compared to the cost of non vaccinated covid

Re: US agencies call for pause in Johnson & Johnson vaccine

#327

Post by santiagobasulto »

myrandomcomment wrote: post #230

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are usi…

But is it really a side effect? If 6 people vaccinated are hit by a car, is that included as a side effect?

Are those side effects lists just a catch it all sort of exception where they throw anything there just in case? Honest question.

Re: US agencies call for pause in Johnson & Johnson vaccine

#328

Post by nscalf »

yboris wrote: post #312

Relevant tweet: https://twitter.com/robertwiblin/status/1381967753234411530 J&J doses delivered: 7 million. Reported blood clotting events: 6. Daily risk of dying of COVID19 in the US: 1 in 330,000. CDC and FDA: Pause the J&J vaccine. Draw your own conclusion on how aligned these folks are with your interests.

I think this is an illustration of an issue that has been seen throughout the entire pandemic. Medicine != Public Health Policy. In general, I would say medicine is too dogmatic to decide on public policy, and public policy is too loose to operate medicine.

Re: US agencies call for pause in Johnson & Johnson vaccine

#329

Post by edmundsauto »

hedora wrote: post #286
InTheArena wrote: post #255

I see a lot of arguments that are basically "people are too stupid to understand risk". That, in turn, comes from the fact that the FDA/CDC/NIH has not covered itself in Glory the last many years. Covid just uncovered the rot, while Trump danced around it, and poured gasoline on the fire. The best thing to get people to understand risk is to actually follow the process in the EUA. Pause, evaluate the outcomes, change…

I’m not sure I understand your argument (and I’m guessing the downvoters aren’t either). This is a situation where the process will definitely, unambiguously, kill more people than moving forward with the vaccine. I guess you’re suggesting culling a small fraction of the population might encourage better behavior at the voting booth? We already have plenty of historical evidence suggesting that’s not true.

I'm not sure how your last graph followed from GP's post - are you replying to the right comment?

GP was saying that the US health agencies haven't looked very good in the past few years, and on Covid, they really have fumbled the comms execution. Before Covid, these issues existed in the agencies, but that was highlighted by the emergency + executive branch that was either incapable or unwilling to make it a priority. That's when it's even more important for our processes, led by our major agencies, to be crisp.

None of this past year was unpredictable. If these health agencies are so affected by the whims of politics, it reveals a systemic flaw.

Re: US agencies call for pause in Johnson & Johnson vaccine

#330

Post by jschwartzi »

spazrunaway wrote: post #236
conistonwater wrote: post #187

Earlier quoted context omitted.

Wait, that doesn't sound quite right: the benefit of taking the vaccine goes not only to you, it's also to the people you would have otherwise infected by spreading the virus yourself.

Put your life on the line for the community, comrade! And sign away your right to legal recourse should you die as a result. You're on your own! You owe the community your life, and the community owes you nothing!

I think there's a really big difference between being FORCED to get the vaccine, and being reminded that your actions have consequences on other people and not just on yourself. Nobody is saying that you should be required to get vaccinated. So really this is just a straw man that you're burning down.
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