Cops called to the pool hall
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I emailed my doctor yesterday regarding a few things, one being which vaccine he recommends once one is available here. His response was that he did not think we would be lucky enough to have a choice; we'll just have to take what's available. But, he further stated, if you do have a choice, he said, "I like the new technology, either Pfizer of Moderna."
Not sure what "new technology" means, but I'll be looking for one of those. I should be in an early group, given my age and past medical histroy.
Not sure what "new technology" means, but I'll be looking for one of those. I should be in an early group, given my age and past medical histroy.
New technology means the Pfizer or Moderna vaccine. They are using mRNA technology that trains your body to identify and kill the virus, rather than using an attenuated or inactive virus.
I posted Pfizer's full data set twice in this thread, as well as the FDA's analysis of the data. Look it over if you are interested.
This is the main reason that public health mandates are being implemented. Called 'flattening the curve' the idea is to limit the rate of new cases such that hospitals do not run out of ICU or emergency care beds. To be clear, each of these beds has a full complement of instrumentation and care devices and equipment. So it is not just a matter of buying more beds from the medical supply place and setting them up, unless you need to park them in the hallway to make those waiting to get into emergency care or ICU more comfortable.
Once they run out of beds, they are moving into triage territory, where folks my age would be shuffled aside to treat someone younger and not as at risk. Not that I am overly selfish in that regard, but why not avoid that avoidable problem?
This goes to explain why some countries have much higher death rates than ours. Some countries do not have the health care infrastructure. Italy got whacked hard in this way, so they ended up with patients dying in the hallway waiting to be treated. So did NYC. My acquaintance that put up covidgraph.com is a Swiss medical student studying medicine in Italy, so although he was not involved in treatment he had plenty of interesting information to share about the situation there. I haven't been able to get a response from him for a while now, so I hope he is alright.
So, when you see a public health order mandating masks and social distancing measures, be aware that this is the result of overwhelmed hospitals, doctors and nurses petitioning the state to 'please do something' to keep from running out of beds. While some governors might be flexing their political powers, our governor, who contacted and recovered from covid-19 only reluctantly sanctioned the state health officer issuing the recent more restrictive orders. YMMV.
My retired nurse friend has been in contact with the local hospital nurses that she used to work with and says that they are overwhelmed and exhausted from treating covid-19 patients. So far they have not run out of beds but other portions of our state has been in the same situation as others, where they are shipping patients across state lines to other hospitals that have beds. As you might imagine, this consumes an inordinate amount of time and energy.
The situation is aggravated by the fact that at least 1700 health care workers, doctors and nurses, have died in the US from treating the sick. Many hospitals are begging for nurses to hire. On top of that, there are those that have to go into quarantine for 14 days, stretching a limited resource even further. The anecdotal stories from nurses who relate that patients who die from covid-19 sometimes do so while denying it exists only illustrates the disconnect from reality that has permeated this entire affair.
It's obvious you don't feel comfortable with vaccinations. That is fine, and your choice. I am not going to write a long reply because nobody will read it. But, please get the facts straight.
The transverse myelitis cases were NOT with the Pfizer or Moderna vaccines, which are the ones up for emergency use authorization. They were in the AstraZeneca/Oxford vaccine trial, which is not up for EUA. All the data is published. I posted it twice. Please look through it.
Phase 3 trials show AstraZeneca COVID vaccine has up to 90% efficacy
www.cidrap.umn.edu
Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says
AstraZeneca's CEO told investors the participant had symptoms consistent with a rare spinal inflammatory disorder, but is improving and may be discharged from the hospital as soon as today.www.statnews.com
These vaccines weren't developed overnight. These vaccines benefited from vaccine research in SARS-CoV-1 and MERS, also coronaviruses.
SARS Vaccine Development - PMC
Developing effective and safe vaccines is urgently needed to prevent infection by severe acute respiratory syndrome (SARS)–associated coronavirus (SARS-CoV). The inactivated SARS-CoV vaccine may be the first one available for clinical use because it ...www.ncbi.nlm.nih.gov
Obstacles and advances in SARS vaccine development - PMC
The emergence of the severe acute respiratory syndrome (SARS) that resulted in a pandemic in 2003 spurred a flurry of interest in the development of vaccines to prevent and treat the potentially deadly viral infection. Researchers around the world ...Recent Advances in the Vaccine Development Against Middle East Respiratory Syndrome-Coronavirus - PMC
Middle East respiratory syndrome (MERS) is a deadly viral respiratory disease caused by MERS-coronavirus (MERS-CoV) infection. To date, there is no specific treatment proven effective against this viral disease. In addition, no vaccine has been ...
Promising MERS coronavirus vaccine trial in humans
Scientists have now conducted a first-in-human trial with a vaccine against MERS (Middle East Respiratory Syndrome). The MVA-MERS-S vaccine was tolerated well and triggered the development of antibodies and T cell immunity.www.sciencedaily.com
Developing Therapeutics and Vaccines for Coronaviruses
NIAID-funded scientists are exploring ways to treat and prevent human coronavirus infections by working to develop new antibodies, drugs, and vaccines.www.niaid.nih.gov
Oh you mean this Pfizer - https://www.fiercepharma.com/pharma...gn-bribery-probes-for-china-russia-operations
Ya know, the one that stand to make billions off of this.
Already proved to have shady dealings with China, but that should be of no concern right...?
Do you know anything about FDA approval?
Obviously not
.It's an absolute joke.
There's 10 million written words, and 10,000 hrs of documentary about it, should you want to educate yourself.
Also big pharma has managed to absolve themselves from any liability on this.
And all those links you like to provide on the vaccine, ever tried to trace any of them down to who the publisher was, who the publisher has taken money from, who funded the studies, ad nauseum....?
I'll give you 1 guess.
And I'm all for you taking a vaccine, who's odds are less than not taking the vaccine.
Knock yourself out.
Don't require me to take it.
But that's not what sheeple do, and they will mandate it.
See where ticket master is talking about requiring you to be vaccinated to attend there events, and also building a app where other venue attendees can locate you and see if you've been vaccinated?
Your job will require it, insurance is unaffordable if you don't get it, kids can't go to school, can't go to the movies, blah blah blah.
You won't be able to participate in society without, by law.
Remove your cranium from your anus.
If your so worried about covid, stay home.
It is your life you're playing with right?
So let us keep doing our thing, meanwhile you stay at home and social distance.
We'll all die off shortly right?
If we're in the middle of a real pandemic, then don't expect to be able to do all the shit you normally do, and expect the rest of the world to all march in order so you can keep up your normal lifestyle routine.
Dumbest shit ever.
If this were a real pandemic, as I stated before, you wouldn't even need to ask people to stay home, or shut down their business, or social distance, people would do it automatically without anyone mentioning anything.
This country fixing to burn one way or the another, and the fallout will make these trumped up corona deaths look like cupcakes in comparison.
Society as a whole has been broken.
2 halves that cannot heal at this point.
You asked if I know about FDA approval, and you said obviously not. Well for your information, I know a great deal about the FDA approval process, it's my job. I work in pharma, specifically CMC. CMC stands for chemistry, manufacturing, and controls. I am directly responsible for gathering and putting together data that is submitted to the FDA, EMA, PMDA, etc...I am specifically responsible for module 3 files of the new drug application (NDA). I have been a part of a few drug approvals. I am currently working on two more.Oh you mean this Pfizer - https://www.fiercepharma.com/pharma...gn-bribery-probes-for-china-russia-operations
Ya know, the one that stand to make billions off of this.
Already proved to have shady dealings with China, but that should be of no concern right...?
Do you know anything about FDA approval?
Obviously not
It's an absolute joke.
There's 10 million written words, and 10,000 hrs of documentary about it, should you want to educate yourself.
Also big pharma has managed to absolve themselves from any liability on this.
And all those links you like to provide on the vaccine, ever tried to trace any of them down to who the publisher was, who the publisher has taken money from, who funded the studies, ad nauseum....?
I'll give you 1 guess.
And I'm all for you taking a vaccine, who's odds are less than not taking the vaccine.
Knock yourself out.
Don't require me to take it.
But that's not what sheeple do, and they will mandate it.
See where ticket master is talking about requiring you to be vaccinated to attend there events, and also building a app where other venue attendees can locate you and see if you've been vaccinated?
Your job will require it, insurance is unaffordable if you don't get it, kids can't go to school, can't go to the movies, blah blah blah.
You won't be able to participate in society without, by law.
Remove your cranium from your anus.
If your so worried about covid, stay home.
It is your life you're playing with right?
So let us keep doing our thing, meanwhile you stay at home and social distance.
We'll all die off shortly right?
If we're in the middle of a real pandemic, then don't expect to be able to do all the shit you normally do, and expect the rest of the world to all march in order so you can keep up your normal lifestyle routine.
Dumbest shit ever.
If this were a real pandemic, as I stated before, you wouldn't even need to ask people to stay home, or shut down their business, or social distance, people would do it automatically without anyone mentioning anything.
This country fixing to burn one way or the another, and the fallout will make these trumped up corona deaths look like cupcakes in comparison.
Society as a whole has been broken.
2 halves that cannot heal at this point.
Nayzilam was the latest drug I worked on to get approved. UCB acquired the rights from my previous company.
Here is the press release and writeup from the acquisition:
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCB
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCB
UCB offers $370M for Proximagen’s epilepsy spray, with NDA to follow
UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen, agreeing to pay $150 million upfront, with further payments of up to $220 million also in the cards. | UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen...
Here is the press release for approval:
UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.
/PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company's newest...
www.prnewswire.com
Suffice to say, I know a few things about the FDA approval process.
You can actually watch the review process first hand, if you want to know more. I watched the proceedings live on Facebook. The recording is on the FDA's Facebook page. This is specifically referring to Pfizer's EUA application.
I am not going to debate politics. I am not a politician, I am a scientist. I was here trying to correct all of the scientific misinformation being strewn about. Since politics was brought into the picture I am out.
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Thank you for your efforts. They did not all fall on deaf ears. The idiots are mostly screamers, reasonable people are fairly quiet.You asked if I know about FDA approval, and you said obviously not. Well for your information, I know a great deal about the FDA approval process, it's my job. I work in pharma, specifically CMC. CMC stands for chemistry, manufacturing, and controls. I am directly responsible for gathering and putting together data that is submitted to the FDA, EMA, PMDA, etc...I am specifically responsible for module 3 files of the new drug application (NDA). I have been a part of a few drug approvals. I am currently working on two more.
Nayzilam was the latest drug I worked on to get approved. UCB acquired the rights from my previous company.
Here is the press release and writeup from the acquisition:
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCB
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCBwww.ucb.com
UCB offers $370M for Proximagen’s epilepsy spray, with NDA to follow
UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen, agreeing to pay $150 million upfront, with further payments of up to $220 million also in the cards. | UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen...www.fiercebiotech.com
Here is the press release for approval:
UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.
/PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company's newest...
Suffice to say, I know a few things about the FDA approval process.
You can actually watch the review process first hand, if you want to know more. I watched the proceedings live on Facebook. The recording is on the FDA's Facebook page. This is specifically referring to Pfizer's EUA application.
I am not going to debate politics. I am not a politician, I am a scientist. I was here trying to correct all of the scientific misinformation being strewn about. Since politics was brought into the picture I am out.
10-4You asked if I know about FDA approval, and you said obviously not. Well for your information, I know a great deal about the FDA approval process, it's my job. I work in pharma, specifically CMC. CMC stands for chemistry, manufacturing, and controls. I am directly responsible for gathering and putting together data that is submitted to the FDA, EMA, PMDA, etc...I am specifically responsible for module 3 files of the new drug application (NDA). I have been a part of a few drug approvals. I am currently working on two more.
Nayzilam was the latest drug I worked on to get approved. UCB acquired the rights from my previous company.
Here is the press release and writeup from the acquisition:
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCB
UCB to expand epilepsy portfolio with strategic acquisition of Midazolam Nasal Spray from Proximagen | UCBUCB offers $370M for Proximagen’s epilepsy spray, with NDA to follow
UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen, agreeing to pay $150 million upfront, with further payments of up to $220 million also in the cards. | UCB plans to bolster its epilepsy portfolio by acquiring a nasal spray developed by Proximagen...
Here is the press release for approval:
UCB announces NAYZILAM® (midazolam) nasal spray now approved by FDA to treat intermittent, stereotypic episodes of frequent seizure activity in people living with epilepsy in the U.S.
/PRNewswire/ -- UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application for the company's newest...
Suffice to say, I know a few things about the FDA approval process.
You can actually watch the review process first hand, if you want to know more. I watched the proceedings live on Facebook. The recording is on the FDA's Facebook page. This is specifically referring to Pfizer's EUA application.
I am not going to debate politics. I am not a politician, I am a scientist. I was here trying to correct all of the scientific misinformation being strewn about. Since politics was brought into the picture I am out.
So does the FDA actually do any test themselves, vetting, etc..?
Or do they just require these companies to do such, and such, and if you have met their guidelines, then you're good to go?
Hang on snowflake, you're gonna get all the "sensible " you can stand shortly.
Maybe they were following Trump's advice...
Tom Saler: Illicit payments are common in some corners of international business
Although President Trump has sought to relax federal bans on international business bribery, enforcement efforts have increased.
www.jsonline.com
At any rate, that is an example of the false equivalence fallacy (i.e. apples and oranges). Paying bribes to get more business does not mean their vaccine will not be safe and effective. Nor does it mean they should not profit from selling it..
Did you read the links? If you do, you should find your answers.
What is your source that supports your assertion that taking the vaccine will be mandated?
"Ticketmaster has been working on a framework for post-pandemic fan safety that uses smart phones to verify fans' vaccination status or whether they've tested negative for the coronavirus within a 24 to 72 hour window."
Sounds like a negative test will also get you in. It would beat everyone having to wear masks.
From: https://www.billboard.com/articles/business/touring/9481166/ticketmaster-vaccine-check-concerts-plan
What are your sources that support those assertions? If it is just your suppositions, that would be an example of the Slippery Slope logical fallacy.
Actually, by not following public health recommendations, it is the lives of others that you are playing with. The mask is not about you, its about others. Do you care about others only if they are close to you? Or do you not care about them either?
So why hurry it along? Does that give one the license to infect someone else, because they are going to die anyways
What makes you think we are not in the middle of a real pandemic?
Do you think that it is a world wide conspiracy where everyone is in cahoots with China?
Wrong-o. During the 1918 flu pandemic, which killed an estimated 675,000 US citizens and about 50M worldwide, people in the US had to be asked to stay at home, shut down their business, social distance and wear masks. When they did not comply, it was mandated. Only after they had to start stacking the bodies of their family members on the back porch or in the spare bedroom, because the morgues were full, did they really start to comply.
So why don't you believe the 'Trumped' up corona virus death figures? They were predicted and only get counted if the coroner lists it on the death certificate as the probable cause of death. Do you think every coroner in every country of the world is part of a conspiracy?
I agree. But that was the case before Covid-19 made an appearance.
True that!
I don’t know what you are getting at, but since you asked, yes the FDA has their own labs and research programs. The FDA is a large organization with several different divisions.
Before you read this, you should look up the terms GLP, GMP, and GCP. Every thing I mention below had to be performed according to GMP guidelines.
However, in terms of drug approvals, they are a regulatory body that evaluates the data (IRB). They have subject matter experts that analyze to see if you have any gaps. If you have gaps, those have to filled, i.e. more studies. It’s not just a check box process. Each program has different risks based on the structure of the molecule, preclinical tox, clinical data, manufacturing process, solid state/physical form, type of dosage, dosage amount, etc...that list could be 1,000 items long. It is not a straight forward process. To your assumption, no you don’t just meet requirements x, y, z, and you get approval.
They also have trained investigators that perform audits. They will actually go to your instruments and perform data checks to see if data was collected, analyzed, stored, and secured properly. They are specifically looking for data manipulation. Every piece of equipment has to be qualified and validated for its intended use. I am not going to go into detail, but this is all part of the code of federal regulations (21CFR). And EVERYTHING has to be documented.
There are horror stories from these audits and are published as warning letters (483’s). As an added bonus they are public:
I remember one from several yeas ago. There was a company in India that was making API and the FDA was inspecting them for GMP compliance. During a tour of the facility, the investigator witnessed holes in the building with bird flying in and out. One auditor even witnessed bird excrement on the actual manufacturing equipment used to make this product. As you can imagine, they didn’t get approved, we’re fined, and were banned as a supplier. I forget the length of the ban, but a letter like that would put a very large dent into their business.
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Thank you for sharing your expertise with us here. There has been a massive amount of "stupid" passed around concerning Covid here and other places...but not in your posts.I don’t know what you are getting at, but since you asked, yes the FDA has their own labs and research programs. The FDA is a large organization with several different divisions.
Before you read this, you should look up the terms GLP, GMP, and GCP. Every thing I mention below had to be performed according to GMP guidelines.
However, in terms of drug approvals, they are a regulatory body that evaluates the data (IRB). They have subject matter experts that analyze to see if you have any gaps. If you have gaps, those have to filled, i.e. more studies. It’s not just a check box process. Each program has different risks based on the structure of the molecule, preclinical tox, clinical data, manufacturing process, solid state/physical form, type of dosage, dosage amount, etc...that list could be 1,000 items long. It is not a straight forward process. To your assumption, no you don’t just meet requirements x, y, z, and you get approval.
They also have trained investigators that perform audits. They will actually go to your instruments and perform data checks to see if data was collected, analyzed, stored, and secured properly. They are specifically looking for data manipulation. Every piece of equipment has to be qualified and validated for its intended use. I am not going to go into detail, but this is all part of the code of federal regulations (21CFR). And EVERYTHING has to be documented.
There are horror stories from these audits and are published as warning letters (483’s). As an added bonus they are public:
I remember one from several yeas ago. There was a company in India that was making API and the FDA was inspecting them for GMP compliance. During a tour of the facility, the investigator witnessed holes in the building with bird flying in and out. One auditor even witnessed bird excrement on the actual equipment manufacturing equipment used to make this product. As you can imagine, they didn’t get approved, we’re fined, and were banned as a supplier. I forget the length of the ban, but a letter like that would put a very large dent into their business.
I have read several studies that say the number of people who got covivid are pretty much equal among mask wearers and non mask wearers. I have so far chosen to spend money at businesses that do not inforce mask wearing. I boycotted walmart and home depot until they quit enforcing their mask policy.
and to add pfizer is the 2nd biggest in the u.s. and their bottom line is not going to be so much greater because of the virus. you can check their stock price and see it has even lagged behind. the reason is they make so much money elsewhere that the added benefit of the vaccine will not affect their bottom line as much as the public would think.
but all companies are out to make money, and many will have to do it in less than perfect ways in other countries as their customs of business standards are lower than ours. overall if these giant companies didnt make billions they would not spend the billions to find new cures as it would not be worth it. and we still would be dying of minor cancer issues and heart problems that now can be fixed without some even going into the hospital or staying over night there.
but all companies are out to make money, and many will have to do it in less than perfect ways in other countries as their customs of business standards are lower than ours. overall if these giant companies didnt make billions they would not spend the billions to find new cures as it would not be worth it. and we still would be dying of minor cancer issues and heart problems that now can be fixed without some even going into the hospital or staying over night there.
I think you’re missing the picture on masks. They do offer some protection to the wearer, but they definitely help to prevent the spread. Coughing or sneezing (or breathing and talking) into a mask vs not having one is an improvement.
I'm the opposite of you, boycotting places that don’t require masks. Wishing you the best.
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Speaking of Pfizer, money and drugs, below is a link to an interesting read on how they got their vaccine done in record time, and the large amount of their own money that it took (they elected not to take any federal money because it would slow them down). The technology used to create their vaccine has the potential to revolutionize creating future vaccines, or making existing ones.
Chembry would be better qualified to comment on that assertion. Although I am familiar with genetic engineering, my last corporate gig was doing IT for a pharma company that made generic painkillers, so I am only peripherally familiar with the process of making drugs under FDA oversight.
It also explains away the assertions by some, who do not know the process, that the release of the vaccine was delayed until after the election for political purposes.
https://www.foxbusiness.com/markets/behind-pfizer-record-covid-vaccine-effort