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Not necessarily. It could just be a dose if healthy skepticism.
COVID VACCINE - The Megathread
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akflightmedic
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I would think for many of those on the "right" and those of "independent" ideology, this would be ideal. As in, see how fast stuff gets done when there is no government regulation??
Just saying, if these safety issues were ignored in coal industry, power plants, or even Wall Street, it would be hailed as a "win"! Anyways, I digress. The last sentence is exactly why I have full confidence in the science and the manufacturers. There IS so much money to be made, if they screw up, they are out of the game. They lose potential billions in revenue. If they get it right, if they are successful, they lock up the market forever going forward....earning trillions over time for their endeavor.
They have way too much profit and subsequent professional credibility at risk to not get it done right. Otherwise, the others in the rear will take the lead and win. Just my personal takeaway on this.
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Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine
The hundred something page study protocol and statistical plans are available there to peruse too.
Let me know where they deviated from GCP or modern standards of the scientific method.
Summit
Critical Crazy
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Hey Sandpit, you got a Bachelors of Science or Bachelors of Conspiracy? Because what you are spinning is not in alignment with reality.
What you have to remember is that vaccination is not meant to a purely selfish benefit. It is a common benefit where the protection of all inoculations is greater than the sum of the individual risk reductions. You protect others as well as yourself.
The liability consideration is not to do with COVID vaccine. It is a general protection because of the massive social good provided by vaccines, thus the liability is socialized to keep cost affordable and thus access equitable.
What you are missing in terms of timeframes is that the reason it takes so long to reach primary endpoints in normal times for a phase 3 trial in other vaccine studies is low prevalence of the studied disease. In a panedemic, reaching the primary endpoint (enough infected study participants out of, say the 44K in the Pfizer trial, that you can then unblind and compare for efficacy) was reached faster. And this is a good thing in terms of providing safety and efficacy data in a timely manner to provide the benefit needed to end this pandemic. These safety and efficacy statistics are from THIS vaccine. That aside, the process of these two EUA vaccine's mechanism of action is not only well understood, but it is a "cleaner" process in the body than most previous vaccines.
In the mean time, one can sit and wring hands about rare potential side effects not yet seen, and that is valid, but not if it means pretending that such potential somehow outweighs the risk of ongoing COVID-19 infections and the impacts required to mitigate the pandemic.
Over 1.1 million vaccine doses given... no deaths. How many deaths for 1.1 million COVID cases, even in lower risk groups?
And what about morbidity and long term effects of COVID? Dead or alive is a shortsighted way to measure impact of illness:
What you have to remember is that vaccination is not meant to a purely selfish benefit. It is a common benefit where the protection of all inoculations is greater than the sum of the individual risk reductions. You protect others as well as yourself.
The liability consideration is not to do with COVID vaccine. It is a general protection because of the massive social good provided by vaccines, thus the liability is socialized to keep cost affordable and thus access equitable.
What you are missing in terms of timeframes is that the reason it takes so long to reach primary endpoints in normal times for a phase 3 trial in other vaccine studies is low prevalence of the studied disease. In a panedemic, reaching the primary endpoint (enough infected study participants out of, say the 44K in the Pfizer trial, that you can then unblind and compare for efficacy) was reached faster. And this is a good thing in terms of providing safety and efficacy data in a timely manner to provide the benefit needed to end this pandemic. These safety and efficacy statistics are from THIS vaccine. That aside, the process of these two EUA vaccine's mechanism of action is not only well understood, but it is a "cleaner" process in the body than most previous vaccines.
In the mean time, one can sit and wring hands about rare potential side effects not yet seen, and that is valid, but not if it means pretending that such potential somehow outweighs the risk of ongoing COVID-19 infections and the impacts required to mitigate the pandemic.
Over 1.1 million vaccine doses given... no deaths. How many deaths for 1.1 million COVID cases, even in lower risk groups?
And what about morbidity and long term effects of COVID? Dead or alive is a shortsighted way to measure impact of illness:
The anti-vaxxers have really come out in force with this one, aligning themselves with right wing groups claiming infringement on their rights to push more pseudoscientific BS on people. What I cant fathom is how this has become a political issue, when really it is a public health emergency of the greatest magnitude.
It has surprised me how many healthcare providers are coming out as not being willing to participate in the vaccine.
Never had a meme been so true.
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Shutting down economies worldwide is absolutely a political issue, and has political, economic and health consequences. The consequences are not a zero sum game, which means all things must be considered when choosing a course of action. Ignoring non-health related consequences results in socioeconomic side effects that have public health side effects (such as increased depression, suicide and substance abuse).
Our world is not a single issue world, and making decisions as if it is or even should be, will have serious and often unforseen repercussions.
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If you really think that, then you don't understand the simple mechanics of non-statist or free market viewpoints. No one - even in the more anarcho-libertarian circles - believes that there shouldn't be any regulation on drug development or workplace safety or the financial markets. They simply differ on whether or not that regulation is best instituted by the federal government. Personally, I think the feds have repeatedly demonstrated themselves far too incompetent and corrupt to be trusted with pretty much anything - nevemind something as important as drug development - but that's another discussion.I would think for many of those on the "right" and those of "independent" ideology, this would be ideal. As in, see how fast stuff gets done when there is no government regulation??
Professional credibility? Out of the game? What are you talking about? These are massively profitable, widely diversified corporations that stand to make billions if the vaccines work out, but will do just fine if they don't. The feds have already paid for the drugs, first of all. Second, no pharmacy refuses to buy inventory from the best-priced distributor because of who makes the drugs. These corporations have plenty of profit motive - you are right about that - but they are bound by none of the restraints typical imposed by informed consumers or the threat of civil liability. This is anything but a free market scenario.
And did you actually read any of that? Do you really know how to interpret it objectively? I didn't think so. Either does the vast majority of the population. People are left to trust the authorities, which a growing percentage of the population is finding harder and harder to do. It isn't as if health authorities have never been wrong, and prestigious medical journals have never hid the truth in order to forward an agenda. You can believe what you are told by those in charge if you want, and that's fine. If you are being completely honest though, you'll admit that your biases are where all of your confidence comes from, not from any actual analysis or understanding of the data. Some others see things differently, and admit that they don't know what it all means and choose not to blindly trust those who say "it's all good - just trust us". And their choice is no less rational than yours - perhaps it is more so.
The liability consideration is very much to do with the vaccine. Liability is one of the primary motivations in pharm development. It is a powerful tool ensuring safety. Take that away, and…..you do the math. There is very limited liability for the producers of these vaccines, and they do not care at all about "social good". Two words: Purdue Pharma.
But what about the principles of self determination and autonomy? It really sucks that so many people have gotten sick and died from COVID, but almost all of those deaths have been in well-defined, easily identifiable groups which could have been well protected given a more thoughtful and measured approach than what we've seen in the US over the past 10 months. Where is the moral imperative for someone who has no contact with those groups to take a vaccine that they don't statistically need, and aren't completely convinced of it's safety and necessity?
Anti vaxxers? Right wing groups? WTH are you talking about?
Remember, this is a brand new vaccine being distributed under emergency authorization that we do not have any long-term data on, and which purportedly protects against a virus which has a very small chance of making anyone outside of a high risk group seriously ill - never mind dying. The fact that anyone who is skeptical of the need to take that vaccine is painted as some kind of extremist is completely inexplicable, and is likely a political statement in itself.
Coronavirus has been heavily politicized from day one. Don't forget the massive screwups by CDC and FDA very early on, and the repeated mistakes, miscalculations, outright lies, and politically motivated manipulations from all levels of government since then. Don't forget that the spread and toll of this thing has been repeatedly blamed on the skeptics and never on those who purport to have the power to effect it's course (but somehow aren't able to), or on the nature of the virus itself. To think that none of that could possibly have had any influence on the vaccine and related recommendations is completely absurd.
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RedBlanketRunner
Opheophagus Hannah Cuddler
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Presently contraindicated. I'm awaiting allergy testing and possibly further information from manufacturer. (History of mild to severe anaphylactic reactions)
I mean I do have a MD, have a masters, and worked in the pharma industry prior to medicine. I did mostly cardiac and vascular device research for US and EU clinical trials in a group that did contracted full service management from protocol development all the way to writing manuscripts. Do I consider myself an expert on clinical trials? Not really, but I definitely still can interpret studies and give medical recommendations.
It brings me sadness that many people conflate science with their own feelings and politics during the pandemic especially those in health care who potentially can influence others.
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VentMonkey
Family Guy
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Had The Rona myself, as I know others on here have as well. I agree.
DesertMedic66
Forum Troll
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Girlfriend, ICU nurse, and myself both had the rona. She had it back in March and I had it in July. She has already received her first vaccine dose and I am on the list to get mine.
After having it, I don’t want anyone to have this virus or pass it along myself. If I get webbed feet from it hey, at least I will swim better.
After having it, I don’t want anyone to have this virus or pass it along myself. If I get webbed feet from it hey, at least I will swim better.
Anti-vaccine and alt-right groups team up to stoke fears of COVID-19 vaccine
Part of California's anti-vaccine movement has expanded its reach during the pandemic. Now it is focused on new COVID-19 vaccines, and working with others to sow government mistrust.
www.latimes.com
akflightmedic
Forum Deputy Chief
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So if they do not agree with NO regulation, they only disagree if regulation should be by the Feds....then who else is there? Which "independent" regulatory body would ultimately have everyone's best interests in mind? Just curious...if not the Fed Govt, then who? Careful, you may find yourself falling into the rabbit hole of conspiracies.
Yes, professional credibility. As any product of theirs would be considered non-trustworthy going forward if they put out a vaccine that was absolute shyte. Did I really need to explain this to you?
Yes, out of the game. As in your vaccine failed, therefore Company X over there who is having no webbed feet development will now control the market, and the future revenue of trillions of dollars over the next few decades...cause this is a long term game proposition. Again, odd how you speak so intelligently yet need these basic explanations regarding business. Sure, they are profit driven which is exactly why they will pump out the best product. Sure, they are a diversified company...which billion dollar company isnt? But do you think the shareholders are all sitting around saying "look guys, we are all bazillionaires...and we could have been trillionaires, but we aren'tt because our vaccine sucked, but that's fine...we are all ok"?? Of course not...
And yes, the feds bought SOME of the vaccines up front....not all, as Trump refused to do so but is now attempting to prevent the other sales to other countries from going where they should. But this discussion is NOT about these particular immediate sales...this is the roll out. It is all about the long term race and having a quality product is the only thing which is going to win.
*This week, Chipotle opened in a location that has held three other CHAIN stores in the past 6 years. Krispy Kreme came and went, Taco Bell came and went, these were not small names with no big bucks behind them or diversified portfolios. I remember when TB and KK opened, massive back ups. Cars in long lines, everyone excited. At the end of the day, the excitement fizzled, less people went, cause ultimately the quality and location just plain sucks. It really does, especially the location. It is just so difficult to get in and out of and not worth the time. Now that Chipotle has opened, they have hired the police to shut down part of the lane of traffic during their opening hours, they have vehicle lines over an hour long right now. It is even crazier than when the others opened!!! Chipotle for this area is "better quality" and it has a higher price point than what most people in this area are used to or can even afford on a regular basis.
All of them got that immediate cash dump, so far none have survived. Will chipotle survive longer than 2 years in this location? Will they make it 5 or even 10 years? I am sure that is their plan, they will just have to keep pumping out quality product as if it is their first week. But yes, even when Krispy Kreme and TB were closing, they had all kinds of sales, damn near tried to give away food to get people in the door...yet people refused to buy the cheap quality.
SandpitMedic
Crowd pleaser
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OxyContin maker Purdue Pharma pleads guilty in criminal case
Purdue Pharma pleaded guilty Tuesday to three criminal charges, formally taking responsibility for its part in an opioid epidemic that has contributed to hundreds of thousands of deaths but also angering critics who want to see individuals held accountable, in addition to the company.
apnews.com
But they'll do the right thiiing! Think of all the pain and suffering and death associated with the opioid crisis..... they have to have done right for the sake of common decency..... except- they willfully and knowingly did not for profit.
How about this COVID vaccine development event in Aussie land where they were using HIV protein to complete part of the sequence of the spike protein. It was caught, after some people began popping HIV+ in testing. (They later tested negative.) The trial was abandoned. They did the right thing here, but would you have known there was HIV sequenced in your vaccine if they didn't tell you? Is there HIV protein in your vaccine today?
Science | AAAS
Here are some other big pharma mishaps. I mean, we can go back and forth all day- there are surely numerous positive outcomes form big pharma also, but I never put it past them.... I'm not pumping out conspiracy theories. As I've said before, I hope it works, but I'm going to wait and see. I don't insult you guys for getting it, I don't think you are less intelligent either. I think it's all about personal choice.
The Ten Worst Drug Recalls In The History Of The FDA
This year’s recall of certain types of Tylenol and Motrin by Johnson & Johnson (NYSE: JNJ), which began in January, brought back memories of the 1982 Tylenol recall. It affected as many as 21 million packages which were in circulation at the time. Johnson & Johnson’s reaction set the bar for...
247wallst.com
Fen-Phen Maker to Pay Billions In Settlement of Diet-Injury Cases (Published 1999)
American Home Products Corp agrees to pay $3.75 billion in total to thousands of people who contend they were injured by taking popular diet pill combination fen-phen; under settlement--one of largest ever in product liability case--people who used one of diet drugs for 60 days or less would be...
Vioxx | Treatment for Arthritis & Recall for Patient Deaths
Learn the history of the once popular NSAID pain reliever, Vioxx. Read about Merck's withdrawal of Vioxx due to its link to heart attacks, strokes & death.
www.drugwatch.com
Anthrax Vaccine: Five Things You Need To Know About The Leaked Army Memo
The Army memo about the bad batches of the Anthrax Vaccine circulating the web over the past week caused a great deal of confusion. Myself and another attorney created a video to explain the memo H…
www.disabledveterans.org
FDA Recalls All Ranitidine (Zantac) Products, Citing Increased Risk of Cancer
The FDA has requested all ranitidine (Zantac) products be pulled from the market immediately. The recall includes all prescription and over-the-counter ranitidine drugs as ongoing investigations uncovered levels of N-Nitrosodimethylamine (NDMA), a probable human carcinogen, increase over time.
Seldane Removed From U.S. Market Over Safety Concerns
Seldane Removed From U.S. Market Over Safety Concerns
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SandpitMedic
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There are a lot of points here- and I don't want to post a long tangent. So here:
1.) I am not anti-vax, nor anti-science, nor anti-govt. I am not a member of a "right-wing" anti-vaccination conspiracy group either.
2.) I did not espouse any conspiracy theories. (Conspiracy theories would be like- lizard people want you to take the vaccine, the vaccine causes sterility, the shadow govt is injecting tiny microchips in you, etc.) Simply not going all-in on a rushed process by big pharma which is shielded from liability is hardly conspiracy theory.
3.) I don't know what Chipotle has to do with any of this, but it should also be a poll. I vote for Cafe Rio.
4.) I have not insulted anyone's intelligence or credentials. In this circumstance I simply would like to observe, gather data, and make my own conclusions before just believing what I hear. I am just having a discussion on the board and presenting my thoughts, questions, data.
4.5) My risk-benefit analysis at this point is that I am a low risk for complications from COVID, I don't blindly trust the development, and I follow all safety precautions to avoid becoming a vector, and there are unknown risks with the vaccines (due to limited data so far) as well as known risks (Identified here for the Moderna vaccine)https://www.fda.gov/media/144434/download (and here for Pfizer) https://www.fda.gov/media/144245/download (Mind you, these reports were generated by the guys who did the studies, who were paid or received grants; not independent replicated studies).
5.) Re: professional medical opinions: mine is consult your primary care provider if you have questions about getting the vaccine.
1.) I am not anti-vax, nor anti-science, nor anti-govt. I am not a member of a "right-wing" anti-vaccination conspiracy group either.
2.) I did not espouse any conspiracy theories. (Conspiracy theories would be like- lizard people want you to take the vaccine, the vaccine causes sterility, the shadow govt is injecting tiny microchips in you, etc.) Simply not going all-in on a rushed process by big pharma which is shielded from liability is hardly conspiracy theory.
3.) I don't know what Chipotle has to do with any of this, but it should also be a poll. I vote for Cafe Rio.
4.) I have not insulted anyone's intelligence or credentials. In this circumstance I simply would like to observe, gather data, and make my own conclusions before just believing what I hear. I am just having a discussion on the board and presenting my thoughts, questions, data.
4.5) My risk-benefit analysis at this point is that I am a low risk for complications from COVID, I don't blindly trust the development, and I follow all safety precautions to avoid becoming a vector, and there are unknown risks with the vaccines (due to limited data so far) as well as known risks (Identified here for the Moderna vaccine)https://www.fda.gov/media/144434/download (and here for Pfizer) https://www.fda.gov/media/144245/download (Mind you, these reports were generated by the guys who did the studies, who were paid or received grants; not independent replicated studies).
5.) Re: professional medical opinions: mine is consult your primary care provider if you have questions about getting the vaccine.
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SandpitMedic
Crowd pleaser
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Quick question. Did either of you get antibody titers for COVID?
If not, why not? If so, were they negative?
Alan L Serve
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RedBlanketRunner
Opheophagus Hannah Cuddler
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If you figure it out...
There seems to be a threshold, a division between rational thinking and the irrational. Take climate change. A significant consensus of qualified reputable scientists have determined X, Y and Z. For the rational mind, that's good enough. Science is never perfect or absolute, so we have to accept the consensus. With the vaccine it's even simpler. As several people have mentioned in this thread, it's basic math. Part of the solution or part of the problem. Yet even with something as simple as running the numbers, this irrational element over-rides the pre-frontals. The same with the anti mask, or swallowing unfounded false information wholesale. A mindset, a mentality not just willing to be duped, but all the way out to rabidly insisting the inane BS being blown must be believed.
Has it always been like this? A part of human nature?
akflightmedic
Forum Deputy Chief
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I did get antibody titers in March or April, I will have to recheck the paperwork. I did this because when I returned from an international cruise in January, both me and my SO were exceptionally sick. I was laid up for a couple weeks sucking on a nebulizer no less than 8x a day, fever, body trashed. Have never been in this bad of shape, ever. I probably should have went to the ER, however I am stubborn. My GF who is epitome of health and never gets sick was laid up for over a week. Anyways, I was negative for antibodies. I have not gone back to be tested again.
And for the record, CR and myself worked very hard on that Chipotle analogy, and I think it is still relevant this morning...even in the absence of CR.
And for the record, CR and myself worked very hard on that Chipotle analogy, and I think it is still relevant this morning...even in the absence of CR.