Cops called to the pool hall

Chembry

AzB Silver Member
Silver Member
An October 20, 2020, article9 in the Observer lists the known side effects that have emerged in the various trials. Chills, fever, body aches and headache are the most commonplace, but at least two cases of transverse myelitis — inflammation of the spinal cord — have also occurred.
Even the U.S. Centers for Disease Control and Prevention warns that the vaccine’s side effects are “no walk in the park,”10 and Saad Omer, director of the Yale Institute for Global Health, has stressed the need for a broad-based outreach campaign to discuss the reality of side effects, as patients might not come back for the required second dose if the side effects take them by surprise.11
Dr. Eli Perencevich, a professor of internal medicine and epidemiology at the University of Iowa Health Care, has suggested essential workers should be granted three days of paid leave after they’re vaccinated, as many will feel too sick to work.12
A December 1, 2020, CNBC article,13 which looked at the frequency of adverse reactions, noted that 10% to 15% of participants in the Pfizer and Moderna trials reported “significantly noticeable” side effects.
Buried way down at the bottom of the article is a suggestion from a past advisory committee member, who proposes the nomenclature of “serious adverse reaction” be changed to "immune response," so they can reprogram how people think about these side effects, even if they end up having to stay home from work because of them.
The article also admits they have no idea what, if any, long-term reactions there might be, which means (as we already knew) that this is a great big public health experiment and, of course, anything that happens post-marketing will be labeled a "coincidence."
In related news, a participant in India’s AstraZeneca trial is now suing the company claiming the vaccine caused “serious neurological damage,”14 and a group of researchers warn the COVID-19 vaccines could potentially increase your risk of HIV infection.15 Then there are the concerns about the COVID-19 vaccine permanently altering your DNA, effectively turning you into a transhuman.16 As you can see, there’s a lot to consider before taking this vaccine.

Do We Really Need a COVID-19 Vaccine?
Berdine also points out that most of his colleagues believe “the uncertainties about safety exceed what they perceive to be a small benefit.”17 Indeed, at this point, a range of data suggest the COVID-19 vaccine may be completely unnecessary. For example:
• COVID-19 mortality is extremely low outside of nursing homes — 99.7% of people recover from COVID-19.18 If you’re under 60 years of age, your chance of dying from seasonal influenza is greater than your chance of dying from COVID-19.19
• Data clearly show that COVID-19 has not resulted in excess mortality, meaning the same number of people who die in any given year, on average, have died in this year of the pandemic.20,21 This is true even among the elderly, as evidenced in a Johns Hopkins University article published just before Thanksgiving. According to the article:22
“The deaths of older people stayed the same before and after COVID-19. Since COVID-19 mainly affects the elderly, experts expected an increase in the percentage of deaths in older age groups. However, this increase is not seen from the CDC data. In fact, the percentages of deaths among all age groups remain relatively the same.”
As soon as the article started trending on Twitter, Johns Hopkins deleted it saying it “was being used to support false and dangerous inaccuracies about the impact of the pandemic.”23
percentage-of-total-deaths-per-age-category.jpg
• Studies24,25,26,27,28,29,30,31 suggest immunity against SARS-CoV-2 infection is more widespread than suspected, thanks to cross-reactivity with other coronaviruses that cause the common cold.
• Asymptomatic people are highly unlikely to spread SARS-CoV-2 — A study32 looking at PCR test data from nearly 10 million residents in Wuhan city found that not a single one of those who had been in close contact with an asymptomatic individual (someone who tested positive but had no symptoms) had been infected with the virus. In all instances, virus cultures from people who tested positive but had no symptoms also came up negative for live virus.

Will COVID-19 Vaccine Save Lives?
Peter Doshi, associate editor of The BMJ, also questions the effectiveness of the COVID-19 vaccines, pointing out that current trials are not designed to tell us whether the vaccines will actually save lives. And, if they don’t, are they really worth the risks involved? Doshi writes:33
“What will it mean exactly when a vaccine is declared ‘effective’? To the public this seems fairly obvious. ‘The primary goal of a COVID-19 vaccine is to keep people from getting very sick and dying,’ a National Public Radio broadcast said bluntly …
Yet the current phase III trials are not actually set up to prove either. None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”
Doshi points out that when Dr. Paul Offit was asked in an interview whether a recorded “event” in these trials meant moderate to severe illness, he replied yes, “that’s right.” But that’s not, in fact, correct. All Phase 3 trials count mild symptoms, such as a cough, as a “COVID-19 event,” and all will finalize their analyses after a mere 150 or 160 of the volunteers develop symptomatic COVID-19 — regardless of severity.
“Part of the reason may be numbers. Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic COVID-19 cases, would be unlikely to occur in significant numbers in trials.
Data published by the U.S. Centers for Disease Control and Prevention in late April reported a symptomatic case hospitalization ratio of 3.4% overall, varying from 1.7% in 0-49 year olds and 4.5% in 50-64 year olds to 7.4% in those 65 and over.
Because most people with symptomatic COVID-19 experience only mild symptoms even trials involving 30,000 or more patients would turn up relatively few cases of severe disease,” Doshi writes.34
“Hospital admissions and deaths from COVID-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people.”
These trials also do not tell us anything about the vaccine’s ability to prevent transmission, as this would require testing volunteers twice a week for long periods of time — a strategy that is “operationally untenable,” according to Tal Zaks, chief medical officer at Moderna.35

COVID-19 Vaccine Poses Rare Distribution Challenges
Questions have also been raised about the potential for the COVID-19 vaccines to “go bad” due to improper storage. Pfizer’s COVID-19 vaccine has to be stored at an unheard of cold temperature even for Antarctica — minus 70 degrees Celsius, or 94 degrees below zero, Fahrenheit. Moderna’s can be kept a bit warmer, at “just” minus 20 degrees C, or 4 below zero F. Both pose a problem for providers who will be administering the shots.
To get an idea of why the vaccines have to be frozen, NPR compares them to chocolates that melt easily.36 The reason the vaccines are so fragile is because they’re made with messenger RNA (mRNA), which turn your own cells into little factories that produce SARS-CoV-2 protein that in turn trigger antibody production.
The problem is that mRNA is easily broken down, so it needs the freezing temperatures to keep stable. Pfizer said its special packaging keeps the vaccines frozen with the help of dry ice. Even so, providers will still have to abide by strict guidelines, one of which says the freezer compartment storing the vaccines cannot be opened more than twice a day, and when opened, must be closed within one minute. Once thawed, the vaccine can be kept refrigerated for five days.
The whole situation makes distribution a challenge, too since the smallest amount you can order is 975 doses. That means the vaccines most likely will have to go to places capable of administering large numbers of vaccines in a short period of time to avoid spoilage. What happens if the vaccine is mishandled and spoils? No one knows. At best, it may be ineffective. At worst, it may cause completely unexpected side effects.
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.

These vaccines weren't developed overnight. These vaccines benefited from vaccine research in SARS-CoV-1 and MERS, also coronaviruses.
 

gerryf

Well-known member
Everyone i work with and associate with plans to take the vaccine as soon as it's available.

But right now, the best case scenario looks like we won't be getting it until next summer, once the health care and at risk populations are treated.
 

Korsakoff

AzB Gold Member
Gold Member
Silver Member
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.
 

Chembry

AzB Silver Member
Silver Member
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.
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.
 

Protractor

AzB Silver Member
Silver Member
The death rate is also influenced by how overwhelmed the hospitals are. Obviously, if they are so full that they can't provide adequate treatment, you are more likely to die if you develop a severe case. Unless, of course, you have connections that will allow you access to the best treatment.
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.
 

De420MadHatter

SicBiNature
Silver Member
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.

These vaccines weren't developed overnight. These vaccines benefited from vaccine research in SARS-CoV-1 and MERS, also coronaviruses.

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.
 

Chembry

AzB Silver Member
Silver Member
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.

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:

Here is the press release for approval:

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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Jimmorrison

AzB Silver Member
Silver Member
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:

Here is the press release for approval:

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.
Thank you for your efforts. They did not all fall on deaf ears. The idiots are mostly screamers, reasonable people are fairly quiet.
 

De420MadHatter

SicBiNature
Silver Member
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:

Here is the press release for approval:

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.
10-4
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?
 

Protractor

AzB Silver Member
Silver Member
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...?

Maybe they were following Trump's advice...


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..

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....?
Did you read the links? If you do, you should find your answers.

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.
What is your source that supports your assertion that taking the vaccine will be mandated?

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?

"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

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.

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.

Remove your cranium from your anus.
If your so worried about covid, stay home.
It is your life you're playing with right?

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 let us keep doing our thing, meanwhile you stay at home and social distance.
We'll all die off shortly right?
So why hurry it along? Does that give one the license to infect someone else, because they are going to die anyways
If we're in the middle of a real pandemic,
What makes you think we are not 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.
Do you think that it is a world wide conspiracy where everyone is in cahoots with China?
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.
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.

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.
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?
Society as a whole has been broken.
2 halves that cannot heal at this point.
I agree. But that was the case before Covid-19 made an appearance.
 

Chembry

AzB Silver Member
Silver Member
10-4
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?
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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Dead Money

AzB Silver Member
Silver Member
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.
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.
 

cueman

AzB Gold Member
Gold Member
Silver Member
The Covid virus is still raging all across the country with more people dying than at any time before. And some people still chose to ignore the fact that wearing a mask provides protection both for yourself and others. They use the argument about "personal freedom." What about protecting other people, does that matter? I think we all can agree that in many states it's mandatory to wear a helmet while riding a motorcycle and seat belts are mandatory everywhere! Try telling a cop about your "personal freedom" when he writes you a ticket for not following those rules. The threat of Covid is just as real and just as deadly.
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.
 

maha

from way back when
Silver Member
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.
 

Maxx

AzB Platinum Member
Gold Member
Silver Member
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.
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.
.
 

Protractor

AzB Silver Member
Silver Member
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.
Could you please post the links to those studies?

Thanks
 

Protractor

AzB Silver Member
Silver Member
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.
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
 
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