* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.
* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.
That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
How did they establish that there are no long term side effects?
That's not to say that it's completely out of the question that there will be long-long-term side effects. But if anything is going to cause long-term issues, my money is on the virus, not any vaccine.
Past performance...
Vaccines are not the stock market. No one doubts gravity because "past performance is not indicative of future results".
How many genetically engineered adenovirus vaccines have there been before?
The vaccines that are your prior are typically attenuated or inactivated virus.
Majorly different category, we are in untreaded space (I'm still planning on getting one)
I don't think we know long-term how this may impact the immune system: does bypassing certain systems/mechanisms cause other problems with future immune response?
It took how long for us to realize as common sense that use of antibiotics allows superbugs to more likely evolve?
Fair enough, but the comment I responded to said: "We know that there are no side effects that are common enough to be of real concern."
Given this statement is not qualified for timescale, I want to know what the basis for it is.
How does the person who made it know there are no side effects on the order of six months or a year that are common enough to be a concern?
Look I am all happy chappy with the vaccine, I will inject that sweet MRNA Pfizer or Moderna vaccines as soon as someone lets me at it, but I still think we need to avoid what Fauci does, which is knowingly lie in order to get people to do what we want them to do.
There is blood clotting risk from AZ? Great, tell me what the risk is and I can deal with it, but lie to me and we are done talking.
With vaccines we know from decades of experience that severe side effects tend to occur very shortly (days or maybe weeks) after the injection. So this is why vaccine trials observe participants for weeks or months, not years, before concluding that the vaccine is safe. Of course this doesn't guarantee that the Covid vaccine don't happen to be an exception. But if that was the approach we took then we would never be able to approve anything, and never get the benefits we know for sure it brings.
But you can? e.g. "We know that there are no side effects that are common enough to be of real concern."?
What deficiency do I have that prevents me from knowing anything for sure that you don't have?
I personally don't see any good reason to think that the risk for long term side effects from the vaccine is higher for the vaccine than for COVID itself.
You can however guess, and make good guesses (I'm planning on getting the vaccine). But it does no one any good to fail to outline unknowns that are steelmanned by "we can't possibly know".
This is a common, but confusing, use of "you" in American English.
Keep in mind that we also don't know the long-term effects of COVID-19. It's possible that people who were infected with mild cases drop dead 1 year and 6 months after the infection. The disease hasn't been around that long, so we simply don't know.
There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
From what I can gather, there’s not terribly much info on what’s known about what’s going into people’s bodies, and what info does exist has arisen from a thick soup of trade secrets and conflicts-of-interest.
Maybe you are responding to the wrong person? I never made any claims regarding what long term effects to anticipate. I asked how the person I responded to know there are no serious side effects on time scales longer than we have tested things on.
> There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
Yes. I know.
Also, to all those saying "clinical trials have succeeded", I strongly suggest them to read said published trial results and look at _measured_ sample sizes used in the results, not total inoculation numbers.
Applying the precautionary principle, particularly if you are not at risk, is a perfectly reasonable position, IMHO.
No, we can't know that. Some affects don't show up for a long time. One example is women.
Women's bodies are complex because they go through so many changes. These changes affect how they respond to medical treatments. In other words:
- Just because pre-menopause women respond well doesn't mean post-menopause women will.
- Just because pre- or post-menopause women respond well doesn't mean women who are going through menopause respond well.
- Just because non-pregnant women respond well to the vaccine for a month doesn't mean that pregnant women will respond well.
- Just because 6-month pregnant women respond well doesn't mean 3-month pregnant women will respond well.
- Any issues with the vaccine during pregnancy may not show up until after the child is born.
- Women's hormones are fluctuating wildly at the beginning and after pregnancy. These are also times that need a lot of representation in the study.
In fact, the amount of change women's bodies undergo affects medical treatment so much that many clinical trials deliberately under-represent women to simplify the study, and then use the results of the trial to recommend prescriptions for women.
Sometimes the answer is easy.
> Hormonal birth control - years of research
This is kneejerk status quo bias.
> I'm fine with anyone to make a decision on them own to take these vaccinations.
Great, but the FDA is not. That's the issue here.
> This is kneejerk status quo bias.
mind expanding why years of research is a 'bias'?
The "you woudn't care about women dying" narrative completely derails the essential discussion (aka when do we determine vaccine to be save) by selectively picking facts from a completely unrelated health area to turn it into an activist subject.
It reminds me on the magnet-troll-logic memes, only this one trying to come up with the completely insane narrative: "If you are concerned of a few more people dying because of a vaccine, you hate women."
The specific issue being observed is "cerebral venous sinus thrombosis (CVST)" in combination with "low levels of blood platelets (thrombocytopenia)" per the Joint CDC and FDA statement (1).
Low blood platelets means anti-clotting treatments can pose a substantial bleeding increase, making this already dangerous condition difficult to treat.
(1) https://www.fda.gov/news-events/press-announcements/joint-cd...
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca? > It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC.
https://www.pei.de/EN/service/faq/coronavirus/faq-coronaviru...
This assumes that we have enough safe vaccines, which we wildly don't.
6 cases in 7 million over 3 months with mostly women being affected is exactly what we'd expect to see.
[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
We 'spend' about one micromort of risk per day of being alive. Or you can spend one walking for 6 hours, or driving 250 miles (or 6 miles on a motorbike)
I just made a website to show all the other stuff we do all the time without worrying with the same (extremely low) level of risk
In the UK there's been 19 people die after ~20 million vaccinations.
Of course some more may show up in coming days from prior vaccinations.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
Edit: I looked into it more and I can get IPv6 and IPv4 DNS servers to serve me both A and AAAA records. The site is now down, however :)
Yeah I banked too much on Cloudflare... I've ramped up its dyno a bit now too. Hopefully that'll keep it up!
www.medscape.com/viewarticle/949108
Per https://vaccinetracker.ecdc.europa.eu/public/extensions/COVI..., that's 30M AZ doses. You're still talking about one in a million chance of death here.
> And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension
Add a few more exclusions and no one dies of COVID, sure.
10 in a million chance of death from covid in the 5-9 age group (the lowest risk group)
This is the perfect example of anti-vacc logic. They pick the latter because they heighten the risk of the former in their mind, while ignoring or downplaying the risk of the latter. Looking at the actual numbers, it makes no sense for anyone at any age to take their chances with covid over the vaccine.
There's been jumbled messaging on this.
The "you still need to wear a mask" thing was, if you dig in on the actual statements instead of the media headlines, "because we don't know yet". An abundance of caution.
Since then, we've gotten quite a bit of good data on that front.
https://www.reuters.com/article/health-coronavirus-israel-va...
> Data analysis in a study by the Israeli Health Ministry and Pfizer Inc found the Pfizer vaccine developed with Germany’s BioNTech reduces infection, including in asymptomatic cases, by 89.4% and in syptomatic cases by 93.7%.
I think it's the wrong call, though, as we saw with masks.
I do not believe the government response has been exceptionally data-driven throughout this whole mess.
There'll be new guidance issued if it pans out.
https://www.nbcchicago.com/news/local/dr-fauci-explains-why-...
> "It may be that we will show that if the level of virus in your nasopharynx because you're vaccinated is so low that you don't have to worry about transmitting, that's going to be a game changer for what a vaccinated person can or cannot do," Fauci said.
> The doctor explained that if the findings are corroborated, Americans will likely see a pulling back on some restrictions, but emphasized "we're not there yet."
Note that other vaccine's that prevent infection also reduce your risk of spreading the disease (measles etc).
So the fact that COVID spreads (not just in rare cases, but enough we all have to remain masked AND socially distant even if vaccinated) is a CRAZY big difference here.
The messaging has been clear - even if vaccinated you MUST wear masks and socially distance - which shows how different this is then other viruses. Given that, it's understandable that people are a bit more meh on the vaccines - because you can still spread it to others either way.
I do wonder about the experts messaging at times. Initially I thought airbone virus, began wearing my leftover N95's from wildfire season. Then they said those don't stop this airborne virus and to take them off. Then they said put them back on. and on it goes.
That's been the media summary of it, but Fauci and others have been pretty clear in their actual statements on this to say "for now", not "forever".
It's highly likely that natural infection provides worse protection that vaccination and we have real world evidence that already suggests this.
1. Two exposures to the spike protein are likely to create a much better long term immune response simply because of multiple exposures in a short period of time.
2. The spike protein produced by the mRNA and J&J vaccines is engineered to produce better response against variants.
3. We've already seen evidence of natural infection performing poorly in rural parts of Brazil with very high initial infection rates (> 70% which is near the herd immunity threshold) like Manaus where we're seeing significant evidence of reinfection where it should be have been difficult for COVID to spread.
2. A vaccine producing (IIRC) two orders of magnitude more antibodies than natural immunity is not necessarily a good thing.
Everyone else is doing the same thing you are, thus the community is giving you the same thing you're giving to the community.
If the real argument is "the cure has a better chance of killing you than the disease, but please risk your life for the community", I'd rather people be honest and say that in the first place.
It's not enough to say you're being cautious. You have to explain why you think it is better to be cautious about administering the vaccine with its attendant risks or to pay the QALYs incurred by the delay when people who would have received this vaccine don't.
This is a low probability event, and the appropriate mitigation may be to do nothing; but there may be some common factor for these patients that might indicate use of a different vaccine or maybe informing people of symptoms of blood clots and what to do if they see symptoms.
The real risk here is eroding confidence in government health sources in general, and vaccines in specific. There were certainly unknown risks before, but now there is a known risk which deserves some study.
What erodes confidence is the complete absence of cost/benefit discussions about virtually any decision that has been made. Including this one.
If this turns out to be about what it looks like now, unpause and go forward. If it turns out to be much more significant, all the better for having stopped; maybe restrict this vaccine to populations at higher risk of COVID or lower risk of blood clots (if that risk can be determined). Both mRNA vaccines and modified adenovirus vaccines are new types of vaccines not used before on a wide scale; pausing to get clarity on a major negative side effect is warranted.
A credible decision would give your estimates of harm/benefit for delaying vaccinating people. You seem all too willing to ignore the people who will become sick or die because of delaying the vaccine. You are only looking at potential harm from not delaying the vaccine. Unfortunately, you have a lot of company.
It seems to me that the delay imposed by a pause in use of the J&J vaccine to make sure healthcare providers are informed of and have appropriately updated diagnostic and treatment protocols is minor, its basically pulling forward by a few days the effects of the 80% week-over-week drop in J&J vaccine supply that was just in the news.
Leading to more people delaying their vaccination. Supply is currently at a level that all doses available are administered, but to the extent lost confidence results in longer delay for high risk patients, that has a cost. When supply exceeds demand, lost confidence will have a cost for those low risk people who delay, as well as the general population which loses out on wider immunity. Delaying the vaccine now certainly also has some cost of the same type, but it's bounded. Another case of a vaccine campaign ignoring warning signs and proceeding without pausing to consider appropriate response to issues as they arise will affect this campaign as well as future campaigns.
Suggesting that effects on the order of the ones seen here is a good reason to delay the vaccine should make people doubt the ability of our public health authorities to make reasonable tradeoffs.
[1] Michigan's Democratic Gov. Gretchen Whitmer declared her state a "COVID hotspot" as cases continue to rise and has asked the federal government to increase vaccines in response. https://abcnews.go.com/Politics/cdc-director-michigan-vaccin...
A legitimate reason for the pause is to assess whether the people impacted have anything else in common. There are alternative vaccines that can be used if a commonality is identified.
As far as hesitancy, the idiot media already does a story for every vaccinated person that gets sick, this isn't going to tip huge swaths of people in either direction.
Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are pretty cautious, and are willing to halt vaccines that show signs of problems.
Agreed that if everyone is rational/good at math the optimal outcome is proceed with dosing, but sadly that is not the world we live in and the “broken trust” scenario might be more damaging.
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.
I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
J&J is also widely used in the US for people who might have issues with scheduling a second shot, for example people who are homeless, or are home-bound.
I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.
“Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses closed or restricted based on what they do rather than the risk profile of their owners and employees).
These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).
yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.
How does one do that math ethically? There are risks if you do and risks if you don't. The FDA is the wrong group to make that call, because they're only concerned with the first kind of risk.
In Canada we reserved the Astra Zenica vaccine for people over 55 because of the blood clot issue. I think that's probably the right call.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.
>> In China you disappear if you publicly say bad things about CCP.
> Yeah, I know what you mean, I called somebody motherfucker and got banned on HN. Freedom of speech is nowhere these days.
ETA: I see you made ninja edits to your comment....
Edit 2: So now you replied that you only added a word or two and then deleted you comment while I were replying. Your comment was only half as long when I replied (all the Twitter stuff wasn't there for example).
> A joint statement from the FDA and CDC clarified that the blood clotting was cerebral venous sinus thrombosis (CVST).
I don’t believe birth control is associated with CVST at a rate of 1/1000. It feels very misleading to use it as a point of comparison.
Again, we're looking at one in a million stats for getting the clots, and one in six deaths amongst that tiny group of cases - without information yet on their comorbidities.
COVID itself causes clots. A lot more than 1/1,000,000. If you're afraid of clots, get the vaccines. Even the J&J one.
https://health.ucsd.edu/news/releases/Pages/2020-11-23-study...
> Overall, 20 percent of the COVID-19 patients were found to have blood clots in the veins...
Even today Physicians still think the body is Art, or a combination of Art and Science.
And the only reason we don't have a science based alternative to the Physician cartel is that they spent literally $400,000,000 on lobbying/bribery in the last 30 years.
Edit- for further reading look up "evidence based medicine debate"
Anecdotally, my pediatrician has an inverted "trust pyramid" in some of their examination rooms. At the bottom—least trust—is "expert opinion."
> Even today Physicians still think the body is Art, or a combination of Art and Science.
I'm not sure why you would think these two things are opposed?
Science most broadly speaking means knowledge, and the scientific method is a means (but certainly not the only means) of acquiring knowledge. But what you do with it is art/craft. Separating the two seems unnecessarily dualistic.
This actually happened.
There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.
I’m the opposite. Covid caused my trust in them to plummet. Perhaps made with the best of intentions, but all the noble lies have eroded my trust.
Same framework that's lead to all of the poor policy decisions over the past year.
> That said I trust that the government agencies know what they are doing here.
If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.
For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.
By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.
It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.
It's ridiculous.
Or as per someone that actually knows statistics: https://twitter.com/NateSilver538/status/1381925025964515330
Build a dam, which if it broke would kill hundreds-of-thousands, or let millions die for lack of water? Oh, we'll just over-engineer it, now we can't afford to buy food to keep the people alive long enough to need the dam; or the lead engineering firm embezzles the money and installs dodgy iron.
We can't wait around for long term studies, whatever point we decide to start vaccines - where they can still be effective for the current population - it's always possible we should have waited a bit longer.
Deaths by Covid are still much more likely than deaths by the vaccine.
Hospitalizations as well, except for the 20-29 cohort https://twitter.com/VikiLovesFACS/status/1379833789334089734
Nonetheless, just because version 1/2 COVID vaccines are good enough for you does not others should just jump on board when other options exist that can vastly reduce risk of infectionand/or death.
In short, blowing the death problem our of proportion unless the options are only nothing vs vaccine.
Masks are supposed to protect others from you. Wearing a mask is not meant to help a person who may be at risk decrease his/her own risk of infection.
In any event, now that spring weather is here in the northern hemisphere and the vaccination campaign has given people hope, social-distancing rules are being flaunted in many countries and at-risk populations may find it hard to properly distance when they leave their homes for e.g. basic shopping. So, since the "other options" don’t always work, keeping up the vaccination campaign is very important to reducing infections.
For those willing to receive vaccination right now under informed consent, I'm all for it. I agree people are over the pandemic and making the situation worse. I disagree with many commenters here that are shaming and/or implying that people like myself are anti-vax vs simply being willing to wait for much more evidence before jumping on board with incredibly widespread usage of an incredibly not well understood treatment.
I'm in a low risk bracket. My country saw an uptick in people canceling vaccination appointments. 40% of 60+ people here are now 'unsure' of taking the vaccine.
I've done nothing but work and follow the rules since this whole thing began. Young people without partners, or young people in general, that are active, have a social life did a complete 180* in their "allowed lifestyles".
I've paid with money, time, a year of my otherwise busy life, for people in risky age brackets, at _little_ benefit to myself. *
But I'm so done, don't tell me you're asking people like me to be stuck in our anti-social and unhealthy living arrangements, while there's a solution that's _safer_ than going to a covid shower?
People like me are done paying, I'm not going to wait around another year, you take the vaccine or you take covid for all I care.
I mean there's still stuff between "fully healthy" or "deadly dead".
Who cares how many clots birth controls produce? What matters is the outcome compared to the thing birth controls prevent - pregnancy.
Do you get more blood clots from being pregnant or from being on the pill? It's order of magnitudes more from being pregnant, therefore if you're sexually active it's safer to be on the pill compared to not.
How is this the top post? People have no knowledge of basic Bayesian statistics.
Same with the vaccine.
> Do you get more blood clots from being pregnant or from being on the pill?
Again, same with the vaccine. COVID itself causes clots, in a very substantial percentage of hospitalized patients.
"The benefits of this medical intervention are worthwhile, despite the risks, given the alternative" is precisely the point being made.
No, because there are other vaccines that don't give you blood clots at all. Your entire point is moot. Pausing temporarily to investigate is hardly controversial. The comparison with birth control is nonsensical.
A vaccination for COVID is not the same as getting birth control. Even if it was, why would you get J&J if you could get Pfizer that doesn't have the same issue?
If all vaccinations had the same blood clotting issue then perhaps you and the original poster would have a point. Given a huge disparity between them with regards to blood clotting taking a moment to investigate this is simply prudent. Making nonsensical comparisons to birth control, well, is not.
Your argument would be reasonable if it was being permanently suspended.
Should the government also just not disclose any side effects? By definition any bad information will make the public lose trust.
The goal is to avoid this sort of consequence:
https://www.fiercepharma.com/marketing/yougov-poll-finds-dis...
> The skepticism shows no sign of slowing, YouGov reports. While trust for the Pfizer and Moderna vaccines rose in all country surveys between December and March, trust for the AZ vaccine slipped in Germany over that span. By early March, 40% said the AZ vaccine was unsafe, an increase of 10% since its earlier December poll.
> The result? Anecdotal reports in Germany and across Europe of people refusing the AZ vaccine and supplies sitting unused in warehouse, YouGov reported—real-world evidence of “the extent of the damage done to the perceived safety of AstraZeneca vaccine.”
https://www.economist.com/graphic-detail/2021/03/22/increasi...
> The AstraZeneca jab, which is cheaper to produce and easier to store and distribute than the vaccines currently being administered across Europe from Pfizer-BioNTech and Moderna, was meant to be a workhorse of the continent’s vaccination drive. That plan could be in trouble, however, if citizens across Europe continue to believe that the AstraZeneca vaccine is unsafe and, as a result, refuse to bare their arms for it.
I believe, as with software, that immediate release of unvetted, incomplete, and still-being-investigated information can be actively harmful to people.
J&J is paused because there are alternatives that don't have clotting to the same degree.
A comparison with birth control makes no sense. Is there some magical birth control that's used orders of magnitude more (Pfizer) and orders of magnitude safer with respect to blood clotting and also prevents pregnancy?
No? Then the comparison is stupid.
IMO that lack of caution is why the USA is in this situation to begin with.
I don't agree with your analysis, I think you can see it entirely the other way, that both this pause and the initial "wait and see" attitude towards Covid are the result of an excessive bias towards the status quo. I remember back in January-February 2020 when people were saying it would be crazy to just shut down air travel, think of the massive economic cost.
J&J isn't being permanently suspended - I bet you within the coming days this ban will be reversed and people can get J&J if they'd like.
Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye.
The vaccine hesitancy this engenders is likely gonna kill more than that one person.
https://twitter.com/NateSilver538/status/1381936112311148548
> Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. It might help if they sought out experts from economics, sociology, psychology, etc., instead of telling everyone to stay in the their lane.