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Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @12:50PM (#28278672)
> the Pfizer vaccine works and is safe

Yes the vaccine has been proven to be safe for most adults in the short-term. But blanket statements like this over-simplify the reality of the situation.

People need to be aware that for certain sub-populations (eg pediatrics & pregnant women), there is insufficient scientific evidence - in terms of clinical trials and longitudinal studies - to conclude that the benefits of vaccination always and universally outweigh the risks.

Until consensus has been established in the scientific literature - and even after that - everyone should be making their own decisions based on personal risk evaluation with the consultation of doctors and other medical professionals.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @01:04PM (#28278858)
Just to be clear, by the standard you're proposing there's also no scientific evidence that posting on Hacker News is safe. There is no scientific evidence that the internet is safe. There is no scientific evidence that wearing a mask is safe.

There is, of course, an INCREDIBLE amount of EVIDENCE for all of these things being safe (including the vaccine). There has simply never been a 100% complete full evaluation of safety to the rigorous standards of an academic paper.

But it's really important to understand that we know TONS of things without having that rigor, and we don't hold the vast majority of our life to that standard.

Heck, we outright know that driving IS dangerous, ridiculously so compared to taking a vaccine, but we still allow that.

Re:FDA Approves First Covid-19 Vaccine by dhanvanthri on Monday August 23, 2021 @01:18PM (#28279055)
Parachutes have not been subjected to rigorous evaluation by using randomized controlled trials.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC300808/

:D

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:33PM (#28279265)
Had to up-vote because this is hilarious, thanks for sharing. As a critique of evidence based medicine they've clearly demonstrated their point, but it's obviously philosophical and the tradeoffs of practical medical interventions are no where near as clear cut as the case of falling from the sky without a parachute.
Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @02:01PM (#28279637)
We have a known-safe vaccine that has been tested on millions of people. We have a known-deadly pandemic that has killed almost 4.5 million people.

While we are not QUITE as clearcut as parachutes, this is still an area where we can reasonably conclude that the vaccine is vastly safer than being unvaccinated.

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:51PM (#28279507)
Just to be clear, you're arguing against evidence based medicine and instead advocating for hasty generalization and jumping to conclusions based on the absence of evidence.

Somewhere between our two points is an optimal middle ground. The holy grail of exclusively evidence based interventions is lofty no doubt, and we'll have to do the best with what we know right now, but to aim for anything less is quite difficult to defend.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @01:58PM (#28279601)
I can't fathom how you could misinterpret a post saying "there's a difference between evidence and peer reviewed academic standards" to conclude that I've abandoned the idea of evidence entirely.

I don't need an academic, peer-reviewed study to tell me that using this site is safe. I don't need one to tell me that masks are safe. It's NICE to have such things, and I'm NOT opposed to them, but they are also NOT necessary for day-to-day reasoning.

I do think we should continue vaccine trials, because we might uncover subtle risks. But until we do, we are in fact at a point where we can conclude that the vaccine is significantly safer than going unvaccinated. What we expect to find going forward is small refinements like "X group should prioritize Y vaccine", not "Y vaccine is in fact more dangerous than Covid"

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @02:30PM (#28280015)
You're attacking a straw man here, my original comment was about the lack of evidence for vaccine safety in certain understudied sub-populations.

> we are in fact at a point where we can conclude that the vaccine is significantly safer than going unvaccinated

You keep coming back to "vaccinated versus unvaccinated" rhetoric and using irrelevant logical reasoning to argue that we should hastily generalize safety results to these sub-populations without citing any scientific literature supporting your claim.

The reality of the situation is a lot more complex, and it's obvious you're neglecting these nuances because for example, you fail to acknowledge how immunity acquired through natural infection is a major factor in the tradeoffs of vaccinating these understudied sub-populations.

I'm open to further debate, but I won't continue responding if you continue to raise the same unsupported arguments.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @02:41PM (#28280160)
> You [...] argue that we should hastily generalize safety results to these sub-populations

I never argued for "hasty" or "generalization."

Simple question: which sub-population are you talking about? Please exclude any sub-population where a statistically significant sample of vaccinated individuals already exists, unless your concern is limited solely to long-term side effects.

If you are concerned about long-term side effects, please cite at least one scientific study explaining why you are concerned about that PARTICULAR sub-group being vulnerable to that PARTICULAR side effect - we wouldn't want to waste time if you can't cite any scientific literature supporting your claim

(P.S. I've only made a single comment about vaccinated -vs- unvaccinated, so you might have me confused with someone else in this thread)

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @03:08PM (#28280528)
Children and pregnant women are the two sub-populations I mentioned previously.

> Given that COVID-19 disease is far milder in the majority of children than in adults, the risk–benefit of a pediatric SARS-CoV-2 vaccine must be carefully weighed [0]

> The prognostic significance, long-term implications and mechanism of this myocardial injury needs to be studied further, especially as vaccination efforts are rolled out to younger children. [1]

> While the safety, immunogenicity, and efficacy data for the 4 authorized vaccines are reassuring so far, none of these vaccines has been systematically studied in pregnant and breastfeeding people [2]

> it is important to remain transparent about the lack of information, acknowledge concerns, and support those who decide to defer vaccination until more data are available [2]

[0] SARS-CoV-2 vaccine testing and trials in the pediatric population: biologic, ethical, research, and implementation challenges (Feb 2021) https://www.nature.com/articles/s41390-021-01402-z

[1] COVID-19 Vaccination-Associated Myocarditis in Adolescents (August 2021) https://pediatrics.aappublications.org/content/pediatrics/ea...

[2] SARS-CoV-2 Vaccination During Pregnancy: A Complex Decision (April 2021) https://academic.oup.com/ofid/article/8/5/ofab180/6220034

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @04:25PM (#28281428)
"Even so, given the reassuring safety and efficacy profiles of the SARS-CoV-2 vaccines that have gained UK/US regulatory authorization to date, the known risks of COVID-19 likely outweigh the unclear risks of SARS-CoV-2 vaccines for pregnant and breastfeeding people."

What are you advocating for? Your own Source Two backs me up here - we have plenty of reason to conclude that Covid is the bigger risk despite the lack of studies. It's right there in the "Conclusion" section.

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @04:48PM (#28281719)
> the known risks of COVID-19 likely outweigh the unclear risks of SARS-CoV-2 vaccines for pregnant and breastfeeding people

Emphasis on "likely" - the authors do not conclude with any certainty, they're speculating based on the available evidence, just like you.

I guess your personal threshold for "plenty of reason to conclude" is lower than mine, and that's okay - to each their own.

But it's very clearly spelled out in the sources I cited: currently there is limited evidence demonstrating the safety and benefit profiles needed to conclude that every child and every pregnant woman should be vaccinated.

Re:FDA Approves First Covid-19 Vaccine by handoflixue on Monday August 23, 2021 @06:31PM (#28282847)
Yeah, but in the absence of better information, we make do with what we have, and pregnant people get vaccinated, right?

I see your point that more research is better, but given the current uncertainty you still have to decide whether Covid or Vaccine is the bigger risk, and all the science says that Covid is the bigger risk.

I'm honestly not sure where we disagree.

Re:FDA Approves First Covid-19 Vaccine by taurath on Monday August 23, 2021 @01:29PM (#28279222)
There are no doctors that will tell you not to get the vaccine unless you go looking for one who will tell you not to. Covid sucks and is filling up the hospitals, and it’s crazy to me that someone decides for themselves that a potential unknown about a vaccine is worse to them than the real virus taking out people left and right. You’re basically saying that the medical establishment is incompetent in the extreme, yet the evidence for that is extremely low.
Re:FDA Approves First Covid-19 Vaccine by mike00632 on Monday August 23, 2021 @12:59PM (#28278785)
1. If "long term" is a matter of years, then yes, the vaccines have been shown to be safe long term.

2. New data shows that the vaccine is indeed safe for pregnant women and it's not recommended that everyone 12 and older get a vaccine.

https://www.cdc.gov/media/releases/2021/s0811-vaccine-safe-p...

Re:FDA Approves First Covid-19 Vaccine by XorNot on Monday August 23, 2021 @12:56PM (#28278744)
For pregnant women the conclusion has been in for a while that COVID-19 leads to a higher incidence of hospitalizations and complications and it has been advice from OBGYN's to get vaccinated with Pfizer ASAP: source - my wife is currently pregnant and we were told this by our OBGYN, who also suggested Astrazeneca would be unlikely to be harmful but couldn't professionally recommend it as their were no formal studies (but a large number of pregnant women have been vaccinated with it not knowing they were pregnant).

For pregnant women the current data is that vaccination is conclusively necessary because they cannot possibly hope to avoid COVID-19 infection when giving birth and while pregnant are much more likely to be severely impacted by COVID-19.[1]

[1] https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/spec...

Re:FDA Approves First Covid-19 Vaccine by criticaltinker on Monday August 23, 2021 @01:14PM (#28279009)
> The conclusion has been in for a while that COVID-19 leads to a higher incidence of hospitalizations and complications

Yes just about any symptomatic illness is going to lead to hospitalization and complications during pregnancy.

I understand how the language on the CDC page you cited may lead you to believe that vaccines are conclusively recommended, but take a look at this page from the CDC [1] (updated August 11th) for a more balance appraisal. They say that evidence about the safety is "limited" but "early data" is reassuring. Almost all of the links on the page you cited are to ongoing trials. It's a misrepresentation of science to say that the recommendation to vaccinate pregnant women is conclusive.

And if we're trading anecdotes, my wife's OBGYN advised her not to get vaccinated yet, because it's unclear what the long-term risks are for mother and baby, and because it's unclear if vaccination provides any additional benefits for mothers who have acquired immunity through natural infection.

If you can provide any citations to primary sources supporting your claim that vaccination is conclusively recommended I would appreciate it - I'm keeping an open mind here.

[1] https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommend...

Re:FDA Approves First Covid-19 Vaccine by XorNot on Monday August 23, 2021 @01:24PM (#28279153)
If your wife has had COVID before she got pregnant, or during and recovered just fine, then that's a very different proposition to my wife who has not had COVID. You're burying the lead hard and frankly if you want to argue against the CDC and ATAGI[1] (the Australia advisory board) then the onus is on you to provide the extraordinary evidence that they shouldn't be believed.

Your proposition is "a virus many times deadlier then the flu in a target group who have more serious outcomes from anything, what could go wrong?"

And your evidence is: "well for someone who currently has effective natural immunity.."

[1] https://www.health.gov.au/sites/default/files/documents/2021...

Re:FDA Approves First Covid-19 Vaccine by AuryGlenz on Monday August 23, 2021 @06:10PM (#28282633)
I think he’s arguing against absolutism. If you’re pregnant and have had COVID or can keep your chances of catching it low by staying/working from home the potential risks probably outweigh the benefit of the vaccine.

But that’s not what’s being communicated.