HHS to require placebo testing of ‘all new vaccines,’ raising questions about approval of updated Covid-19 shots
- Thread starter BPKY
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Wait so you mean all those safe and effective jabs were never tested against real placebos? I’m shocked
You'd have to be a complete moron to get another Covid shot. And you'd deserve what you'd get, harmful long-term side effects included. There is no way I'd ever get another poison Covid shot, including if the government mandated it. It's not a vaccine.
i remember talkign to people during covid who would go to these testing sites and wait for hours, to get tested, even though they didnt show any symptoms.. it blew my mind. And they would go once or twice a week. again, just drive and sit in their car in these long lines.
i was like, "why?" if you dont have symptoms, feel fine, what the hell are you doing? just a mental sickness man, sooo weird. the left wing media did their job and scared everyone out of their minds and caused this behavior.
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Trump and doctors told me to get those shots, but by leveraging my superpowers, I was able to formulate my own opinion [and be correct]
Yeah my neighbor had two boys 5 and 7 and was convinced they had to be vaccinated in spite of the fact kids were hardly impacted by the virus and the shot was bad for some kids. And she was so happy the school required masks for these kids.
Obviously she was a libtard.
Look..............
When it first came out, I was like the boy in the bubble. I rushed to first get my mom vaxxed then myself. Wasn't so much fear for myself, but couldn't live with myself if I was lackadaisical about this, then got it, gave it to my mom and she would die (she didn't)
Did get Covid............twice over the past 5 years. The first time it was an annoying flu, the second time a cold with fatigue.
My points here, I am not going to make fun of whatever fears and actions/reactions people did when Covid first came. No one really new. And the first strain was particularly bad.
But as we have moved on, those relatively healthy people still living in this Covidphobia are either one of the three or a likely all 3.
1) pussies
2) The mask is the left's version of red MAGA hat and just wear it to virtually signal "I am a progressive!"
3) Hell, long term Covid effects has clouded my brain and I forgot what point 3 was going to be.
there was a concentrated effort by mainstream media to make this country afraid, to make people scared to death. and it wasnt out of fear or ignorance, it was a controlled and concentrated effort. people thought if you got it, you needed hospitalization when in reality, less than 2% of these cases required going to this extreme.
again, this wasnt an accident, f'in people were wiping down their grocery bags with disinfectant spray for Christ Sake..
i quit going to chinese rub N tugs for crying out loud. well, i didnt stop entirely, but i thought about it.
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Spoiler alert
Every vaccine has been studied vs placebo to establish safety and efficacy.
When next generation vaccines are developed they are tested against the standard vaccine
May surprise folks - but not treating people is unethical .
Was the superpower having nobody want to be around you ?
Have fun twisting up a CNN article, everyone is dying to hear your honest assessment
you are getting into a debate on covid with posters who admittedly lysol sprayed their own clothing before entering their homes and still wear masks in their cars even when driving alone..
i just wanted to warn you with who is on the other end of this debate...
these guys wanted people to lose their jobs for not getting the vaccine, i kid you not. unless you were an illegal alien crossing the southern border of course, for some reason, they shouldnt be forced to get the shot. not sure the reasoning on that one
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I already replied to the content
By stating all vaccines have already had placebo controls during their initial development .
This isn’t new .
When new vaccines are developed they are compared through randomized studies to existing vaccines.
It’s very clear much like the heroin addict , you don’t understand how anything works
Good point
Hey - quick question- who makes worshiping a geriatric their entire personality, including profile ???
Reformulation with new strains for an existing vaccine....it's like you don't understand the words you're saying. The answer to your question is because it is a reformulation with new strains
I do
The problem is you don’t
Let’s us an example:
The trivalent flu vaccine flu zone
It’s called trivalent because it’s comprised of 3 strains of influenza .
Each year - based on what the dominant strains of influenza is predicted - they alter the valence in the vaccine .
The vaccine is self is not a new vaccine every year .
Frankly , same now is true or the covid vaccines and pneumonia vaccines .
New placebo trials aren’t necessary as the safety and efficacy has been demonstrated already .
Let’s extrapolate-
Do you think when a generic medication is produced or a biosimilar - they should be required to conduct all the same placebo trials as the same brand medication who has already conducted those studies?
Is that actually efficient and cost effective?!
Or is it the actual intent is having the heroin addict crank to ensure vaccines aren’t used?’b
Except for one very small detail. THE COVID SHOT ISN'T A VACCINE!!!
Like you mentioned, strains are predicted, and sequences are procedurally generated to target them, which unlike your claim, leaves next seasons efficacy as a complete unknown. There are millions of influenza sequences, and plenty more than 3 strains of Covid. It doesn't state anywhere in that article that they'll they'll be required to conduct the same trials. Right now, this seems cost effective for vaccine manufacturers [spray and pray]
Active-control trials. They are not uncommon, and are part of a standard toolbox of trial types used not just in vaccine development, but in the development of many drugs for serious diseases where existing approved or established standard-of-care treatments make the use of placebos unethical.
If using placebos in all situations is required, even when their use is unethical, development of vaccines and/or drugs for many serious diseases will be severely curtailed, or halt entirely, or continue in some fashion entirely outside the US with no chance of becoming available in the US.
Typically though, announcements of "policies" like these are so vaguely worded, they do nothing but cause confusion and bottlenecks because they aren't implemented with the guidance necessary to inform the experts charged with implementing them, and things eventually go back to the way they were before because they are ultimately unworkable, just after a lot of wasted time and resources.
If using placebos in all situations is required, even when their use is unethical, development of vaccines and/or drugs for many serious diseases will be severely curtailed, or halt entirely, or continue in some fashion entirely outside the US with no chance of becoming available in the US.
Typically though, announcements of "policies" like these are so vaguely worded, they do nothing but cause confusion and bottlenecks because they aren't implemented with the guidance necessary to inform the experts charged with implementing them, and things eventually go back to the way they were before because they are ultimately unworkable, just after a lot of wasted time and resources.
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I got my second covid shot at Giant Eagle. I was walking around the store and suddenly I couldn't feel my lips when I licked them.
Like I just left the dentist. So I went back up to the pharmacy,told the pharmacist and she was obviously concerned.
She asked me a series of questions ending with did I think I needed an ambulance? No.
But ever since,when I eat something it sometimes tastes salty and sometimes like a copper taste .
A good friend of mine is an ER doc in the area and told me I wouldn't believe the stuff they were seeing. Said he couldn't say if it was or wasn't caused by covid but some *curious* things they didn't notice before.
There's at least 2 people here that I told right away so they've been interested to see if it ever went away which it hasn't.
The pharmacist took all my info and which vaccine it was and said she was going to report it. No one ever got back to me but let me tell you losing your appetite because the pizza i use to love tastes like someone poured salt on it really sucks. At this point after how many years I don't feel sorry for myself or anything, it's just something I've been dealing with and probably will forever.
Like I just left the dentist. So I went back up to the pharmacy,told the pharmacist and she was obviously concerned.
She asked me a series of questions ending with did I think I needed an ambulance? No.
But ever since,when I eat something it sometimes tastes salty and sometimes like a copper taste .
A good friend of mine is an ER doc in the area and told me I wouldn't believe the stuff they were seeing. Said he couldn't say if it was or wasn't caused by covid but some *curious* things they didn't notice before.
There's at least 2 people here that I told right away so they've been interested to see if it ever went away which it hasn't.
The pharmacist took all my info and which vaccine it was and said she was going to report it. No one ever got back to me but let me tell you losing your appetite because the pizza i use to love tastes like someone poured salt on it really sucks. At this point after how many years I don't feel sorry for myself or anything, it's just something I've been dealing with and probably will forever.
I'm sorry you've been having these taste problems, ONGB. Unfortunately, these types of problems associated with people who have had the Covid shots are far too common. I've talked to people I know and trust and they have the same problems with taste and smell. Others have issues with brain fog, forgetting things they used to remember easily, heart and breathing issues with what were previously healthy people.
It's why anyone who takes those poison shots now does so at their own demise. I can understand certain vaccines that actually are vaccines that help to prevent the contraction and spread of viruses. But the Covid shot did none of that and isn't a vaccine. It just caused the types of problems that you described.
We have to remember that the drug manufacturers are businessmen. The word "ethical" means as little to them as any automobile manufacturer. They measure the cost of victim lawsuits against their impact on profitability. They conduct fraudulent trials. The term "Ethical" is part of their standard toolbox of sophistry used to persuade consumers and get their products approved.
Businessmen in pharma may or may not be ethical, but the design of clinical trials and their conduct are overseen by both institutional review boards (IRBs) and FDA scientific review divisions, which are typically far down the chain of any agency bureaucratic interference and are firewalled from contact from the companies or academics conducting the trials. Every clinical trial protocol, or revision to that protocol, has to be approved by an IRB and, for an drug intended for eventual marketing, is reviewed by the most relevant FDA scientific division. Any study done in the US is also beholden to be conducted, by law, according Good Clinical Practice (GCP) standards, and outside the US, its equivalent is the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), which has similar standards that most all 1st world countries adhere to by law. If a study is not conducted according to these standards, the data cannot be used to support an approval of a drug product in these countries and is therefore useless. Independent Data Monitoring Committees are also used to examine unblinded data as it comes in during the trial. These committees help determine whether to terminate the study early for either safety or ethical reasons (such as either negative or very positive results). Serious, unexpected adverse events reported by investigators participating in these trials are also required to submitted by companies within 7 to 15 days, depending on severity, to the FDA.
Bottom line, unethically designed clinical trials either are prevented before initiation by IRBs or, for first in human trials, the FDA scientific review divisions, which can also stop them at any time, by using its clinical hold powers. All trials in the US are also required to be registered and posted at clinicaltrials.gov for the public to search and obtain information about. The oversight and legal requirements of ethical and risk/benefit considerations of trial design doesn't stop all bad behavior, as there certainly are cases where companies have been found to falsify, cherry pick, or suppress data. These issues are usually discovered during inspections of clinical site records, which are required during the drug approval process, and usually such anomalies eventually reveal themselves in the data and disqualify it. There is also regular communication between the FDA and its European equivalent, the EMA, which share information about such things. Clinical trials are expensive to conduct. Companies, for the most part, can't easily operate trials in a rouge fashion, as data obtained in such a way will be unusable to obtain marketing approval anyway, and open them to major financial and litigative risk, and because of legal restrictions under the US Food, Drug, and Cosmetic Act. Doesn't stop all intentional bad actors from doing intentionally deceptive things, but it severely curtails such things in the US and the rest of the developed world.
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Not trying to be a smart ass but two things. Please explain how using inert saline placebos is unethical ?
And why is she wrong
Yes. I am definitely saying that at the clinical review division level, where scientific decisions are made during the drug development stage, such as whether to put a trial on clinical hold, there is no influence of the money Pharma pays in user fees under the Prescription Drug User Fee Act (or other UFAs as far as I am aware).
At a higher level, the influence of those fees comes at the negotiation phase that occurs every five years. That is where the fee structure is negotiated in return for certain review timelines the Agency must attempt to adhere to, as well as the introduction of new programs that require the review divisions to provide feedback on company development plans and progress. But outside of that, the fees paid have zero influence on individual medical scientists, statistician, pharmacologist, toxicologist, chemist, or clinical pharmacologist conducting their review of information that has been submitted.
Now, at high levels, there can be a lot pressure that can be applied, from disease advocacy groups and from litigation pressures. I would say, the primary outside influence driving decision making of drugs in recent years has been the Agency's lawyers fear of litigation from companies. These companies willingness to go the route of litigating an approval of their product if it runs into Agency opposition, this fear of being sued, has curtailed more the Agency legal regulatory powers than anything else, and decisions of review divisions on drug approvals have been more subject to being overturned from above due to these pressures, although it is still fairly uncommon.
Commissioners of the FDA have had no influence on the day to day scientific review activities.
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Placebos are unethical when designing trials for serious diseases where patients need to be treated with the standard of care, such as when not receiving treatment will likely result in irreversible morbidity. You can't take someone off treatment and place them on placebo for the purposes of testing an unproven investigational product.
Gotcha. But if your comparing a vaccines effectiveness to a placebo why would you use anything other than a completely intert placebo (ie saline).
I don't have any first hand knowledge of vaccine development, so I can only speculate that the adjuvants and/or excipients included in potential vaccines products, or even just the injection of any non-specifically targeted protein itself, might have their own effect on stimulating an immune response, so not including them in a placebo could confound the ability to determine how the vaccine itself might prevent or mitigate disease. That is just off the top of my head. I do not know what is standard in the vaccine development world to comment with any sort of personal scientific expertise. I'd have to look into it more thoroughly, which I frankly don't have time to do.
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Actually McClelland works at The Duke Bryan Center for research and has for years - that’s his actually job .
The fact you think there board positions are active is telling.
What other big businesses do you think are bad , comrade ?
