CoVID-19 / SARS-CoV-2 Information and Questions

[crazy4life]

Are you under the impression that 275 CVAs (205 of which occurred in the elderly) across Europe in this timeframe are an unusual amount?

I am under no impressions whatsoever, posted the data. Not qualified to interpret it. Are you a medical doctor, virologist or in any way qualified to interpret the data. If so please interpret away. I would be very interested in a professionals opinion. Please post your credentials also so we can judge your skill level.

Thanks for your valuable input.

 

[Jim_in_Delaware]

95% of the population in the United States with children has decided that they looked at the data and decided “NO” when it comes to vaccinating their children with a booster that was tested on 8 lab mice."

I hope that you don't really believe this nonsense. Drugs or vaccines would NEVER be available to the general population based solely on lab results, let alone a study done with just 8 mice. They would never be approved (or available by EUA) by the FDA without clinical trails having been done.

Hmmmmm me thinks that they all can’t be silly conspiracy nutjobs. 53% of the adult population said “NO” Thats millions of people who decided not to believe big Pharma and their propagandists. Just because some committee of 10 or 15 people decided to approve something does not make it a good idea.

There is no committee of 10 to 15 people that decides to approve the use of vaccines to the U.S. general public. Approval and licensing of vaccines falls under the FDA. The FDA divisions are staffed with M.D.'s and PhD's and these folks (with the concurrence of senior management) make the determination whether new drugs or vaccines are safe and effective and should be approved for use or may be used under an EUA. They do NOT set the prices for products they review, nor decide what should be the public policy for their use. The FDA doesn't make their decisions in a vacuum. It is a science-based Agency and decisions are guided by the work of other Agencies, like the NIH and CDC, findings from Academia, and data submitted by industry (which undergoes extensive review by the Agency.) They also often use advisory committees, composed of experts outside the FDA to get their advice on new drugs and vaccines. The FDA is not bound by the votes of an advisory committee, and will sometimes (rarely) approve a product against the vote of an advisory committee, if they think it is in the best interest of the public to do so. The CDC is responsible for public vaccine policy. They have their own advisory committee, the Advisory Committee on Immunization Practices (ACIP) which includes 15 voting members responsible for making vaccine recommendations. Like with the FDA, the CDC relies on their advisory committee for advice, and makes the final themself.

I do like having a debate with you though. You seem to be able to have a discussion without resorting to name calling and trying to browbeat people into seeing that your opinion is the only one that matters.

I think the goal of this whole thread was to have an open, and honest, discussion on the Covid vaccine, as was the intent of the earlier, locked, thread. I am recently retired from the FDA (35+ years), as a drug manufacturing expert, and I have tried to share my knowledge of the approval and manufacturing process. In the end, knowledge is our best weapon against this, and other, viruses. My sincere hope is that folks seek out the science for making their health decisions. Personally, I am vaccinated and double boosted against Covid. I am immunized as much to protect my close family members as myself. I do understand that no vaccine is 100% safe, but I understand that the benefits of being vaccinate FAR outweigh the risks. If someone else, chooses not to be vaccinated or boosted, I respect that opinion, but I hope they have made an educated decision to reach it.

Jim

 

[adrianp89]

The nation just watched an elite 24 year old athlete suffer from cardiac arrest. I am curious if myocarditis was at play here. He wouldn't even be the first player to suffer from it on his own team.

 

[seanmclean]

I am under no impressions whatsoever, posted the data. Not qualified to interpret it. Are you a medical doctor, virologist or in any way qualified to interpret the data. If so please interpret away. I would be very interested in a professionals opinion. Please post your credentials also so we can judge your skill level.

Thanks for your valuable input.

There are roughly a million CVAs in Europe every year. 275 (of which 1/3 were not medically verified) were reported during this surveillance period. European countries, on average, are about 70-80% vaccinated. The EU population is close to half a billion. Do your own math, and draw your own conclusions.

I am not a physician, but my credentials are just fine - feel free to google them. I'll save you the retort though, I work in pharma (oncology), and not for a company who made a single COVID product.

 

[adrianp89]

There are roughly a million CVAs in Europe every year. 275 (of which 1/3 were not medically verified) were reported during this surveillance period. European countries, on average, are about 70-80% vaccinated. The EU population is close to half a billion. Do your own math, and draw your own conclusions.

I am not a physician, but my credentials are just fine - feel free to google them. I'll save you the retort though, I work in pharma (oncology), and not for a company who made a single COVID product.

All that came up was this..

 

[crazy4life]

Jim

I hope that you don't really believe this nonsense. Drugs or vaccines would NEVER be available to the general population based solely on lab results, let alone a study done with just 8 mice. They would never be approved (or available by EUA) by the FDA without clinical trails having been done.

Hmmmm.

Bivalent Vaccines Approved After Testing on 8 Mice and 0 Humans

Regulatory agencies have neglected to inform the public that no human studies were done before the approval of the bivalent vaccines and that the clinical study referenced included only eight mice. This is unprecedented and reckless.

worldcouncilforhealth.org

https://news.northeastern.edu/2022/08/24/genetically-modified-mice/

https://www.cbs17.com/community/health/coronavirus/fact-check-were-new-covid-19-boosters-tested-in-just-8-mice-should-it-matter/

Science | AAAS

www.science.org

"How can authorities consider authorizing vaccines without data from human trials?

I know you worked for the FDA and have the utmost respect for the rank and file workers as I have had to deal with them on validation reqirements for the Pharmaceutical Industry.
I will quote Don Vito Corleone and say that the "fish rots from the head". 8 of the last 9 commisioneres have gone on to work for Big Pharma after leaving the FDA with multi million dollar salaries. The FDA has gone against their own commitees time and time again to approve drugs that only seem to make the company that produced them huge profits.

There is a Cogressional investigation ongoing as we speak.

House investigation says FDA approval process of Alzheimer's drug was 'rife with irregularities' | CNN

A congressional investigation found that the US Food and Drug Administration's "atypical collaboration" to approve a high-priced Alzheimer's drug was "rife with irregularities."

www.cnn.com

"At that meeting, none of the committee’s members voted to say that the studies presented strong evidence that the drug was effective at treating Alzheimer’s."

This is just 1 example. Wonder if there are any higher ups that will find a job with Biogen in the near future. 57,000 dollars per year with it being overwhelmingly being paid for by Medicare. ie. the taxpayer.
Two highly respected people in your own agency resigned after highly illustrious careers. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, and deputy director Phil Krause.
I will take the FDA recommendations with a grain of salt in the future.

This is just one example and there are many more. You can research if you would like.

You keep saying that people should research and make their own decision on whether to be vaccinated. This statement while true is disingenuous at best. People had to get the vaccination or lose the ability to feed their families. They did the research and decided it was not in their best interest to take the vaccination. Their choice was feed my family or inject something into my body that I determined that was not worth the risk. Where was their choice that you said should be available to everyone?

 

[crazy4life]

Do your own math, and draw your own conclusions.

Do you deny that there are thousands of vaccine injured?
Do you deny that there are countless vaccine deaths?

Hpw many deaths are acceptable in your own math.
How many debilitating injuries are acceptable in your own math.
Is it 1, 100, 1000, 10,000, 100,000 or 1 million.
I am genuinely curious about your response to this question.

I did the math and came up with my own conclusions.

 

[seanmclean]

Do you deny that there are thousands of vaccine injured?

No.

Do you deny that there are countless vaccine deaths?

Yes.

Hpw many deaths are acceptable in your own math.
How many debilitating injuries are acceptable in your own math.
Is it 1, 100, 1000, 10,000, 100,000 or 1 million.

Relative to the risk of the disease under study and the prevailing background rate of adverse events.

I am genuinely curious about your response to this question.

Uh huh.

I did the math and came up with my own conclusions.

Clearly, and that's certainly why you flagged an infinitesimally small number of CVAs relative to the background rate of events in the general population.

 

[Jim_in_Delaware]

@crazy4life,

Maybe we need to be clearer in what we are talking about. The vaccine for children was approved after clinical trials. In the newer post above, you are addressing the bivalent vaccines. These vaccines have minor changes to the mRNA and thus it appears that they will be allowed to be used via EUA, as there does not seem to be an impact on the safety of the virus because the manufacturing process is identical, minus the small amount of genetic material that is tailored to the new variant. (Thanks for posting the above article links!)

The approval of the Alzheimer’s drug is an interesting one. Twenty years ago, this drug would not likely have been approved based on the effectiveness data. However, the pendulum has shifted, and the needs of patients have a much higher role than in the past. If you, or your family, have a devastating illness, and there are no other drugs available to treat the illness, do you want to have access to a medication that may (or may not) help? Interestingly, FDA use to routinely get criticized for not making these the types of drugs available to patients in need.

I have not read any news accounts that either Gruber or Krause left the Agency because of any actions that occurred at FDA during the vaccine review process. Gruber and Krause, according to news reports, left the Agency because of anger over the FDA's lack of autonomy in booster planning. So, please, let us not confuse their actions as a rebellion against the vaccine approval process. There seems to also be some concern that many of the recent FDA Commissioners have gone to big pharma leaving the FDA. I will just note that FDA Commissioners are political appointees appointed by the President, and seldom serve more than 3 - 4 year terms. The FDA Center Directors for the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are not political appointees and are long term civil servants. It is these Directors who give the final Agency approval for new vaccines (CBER) and new drugs (CDER). (I do believe, however, that an Emergency Use Authorization is signed off by the FDA Commissioner.)

We could always talk about sometime fun, like the life cycle approach to process validation.

Jim

 

[crazy4life]

@crazy4life,

Maybe we need to be clearer in what we are talking about. The vaccine for children was approved after clinical trials. In the newer post above, you are addressing the bivalent vaccines. These vaccines have minor changes to the mRNA and thus it appears that they will be allowed to be used via EUA, as there does not seem to be an impact on the safety of the virus because the manufacturing process is identical, minus the small amount of genetic material that is tailored to the new variant. (Thanks for posting the above article links!)

The approval of the Alzheimer’s drug is an interesting one. Twenty years ago, this drug would not likely have been approved based on the effectiveness data. However, the pendulum has shifted, and the needs of patients have a much higher role than in the past. If you, or your family, have a devastating illness, and there are no other drugs available to treat the illness, do you want to have access to a medication that may (or may not) help? Interestingly, FDA use to routinely get criticized for not making these the types of drugs available to patients in need.

I have not read any news accounts that either Gruber or Krause left the Agency because of any actions that occurred at FDA during the vaccine review process. Gruber and Krause, according to news reports, left the Agency because of anger over the FDA's lack of autonomy in booster planning. So, please, let us not confuse their actions as a rebellion against the vaccine approval process. There seems to also be some concern that many of the recent FDA Commissioners have gone to big pharma leaving the FDA. I will just note that FDA Commissioners are political appointees appointed by the President, and seldom serve more than 3 - 4 year terms. The FDA Center Directors for the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) are not political appointees and are long term civil servants. It is these Directors who give the final Agency approval for new vaccines (CBER) and new drugs (CDER). (I do believe, however, that an Emergency Use Authorization is signed off by the FDA Commissioner.)

We could always talk about sometime fun, like the life cycle approach to process validation.

Jim

In my post I specifically called out the booster shots. I will give you a pass on that one because it seems that you are not the only one who failed to notice that particular fact.

I am all for drugs to help debilitating illnesses. You will not get any argument from me on that fact. I just want to make sure it has been signed off by the experts in their field and not by some politically appointed golf buddy of the president. Not one of the 15 experts that were hired by the FDA for review of aduhelm voted to approve. If that don't make the hair on your neck standup you are a better man than me. That is my point and nothing more nefarious regardless of what some may think. In my recollection Gruber and Krause resigned in protest due to the pollitalization of the vaccine process by the CDC and undue influence being exerted on the FDA. These were highly respected and long time employees of the FDA. If they were willing to end their respective careers it must have been an extremely serious affair.

On another note is it really necessary for me to produce 9 documents and borescope an orbital weld on a Wif line. And lets not forget to etch the weld also. Thank God for computers and flashdrives. When you have 10000 orbital welds to keep track of it can become overwhelming, let alone 20000 or more. I put the men that do not measure up to my standards on that project and they usually are on to someone else's team forthwith. My son is a Process Chemical Engineer for Jacobs and he can deal with Validation issues. I love him to death for that fact alone.

It is men like us that are in the trenches everyday putting their boots on and building America. The stuffed shirts not so much.
I just retired a couple years ago after 38 years of hard work and providing for my family. Civil discourse has seemed to have went the way of the rotary phone and milk deliveries.

Good Day

 

[the MfM]

Civil discourse has seemed to have went the way of the rotary phone and milk deliveries.

And grocery store clerks that would walk your cart out to your car and load your bags.

Now we have no bags allowed, self check outs and cart corrals.

… and a “vaccine” that required four doses in 9 months, doesn’t prevent transmission and only reduces severity of symptoms.

Coincidence?

 

[Beachbummer]

So if we had cashiers pushing groceries to your car the vaccines would be more effective?

 

[Jim_in_Delaware]

Now we have no bags allowed…

I gotta say I don’t miss the plastic bags at the market. Here in Delaware we moved away from plastic bags last year. I find the paper bags with the handles to be much superior. Sometimes change is good!

 

[adrianp89]

I gotta say I don’t miss the plastic bags at the market. Here in Delaware we moved away from plastic bags last year. I find the paper bags with the handles to be much superior. Sometimes change is good!

We use the .99c plastic bags. My wife buys a few every year... why anyone would not use these is beyond me. 3 of bags can hold what 12-15 traditional plastic bags can carry. We use the extra large bags for Sam's club trips.

 

[Jim_in_Delaware]

We also have two of the thick, insulated Sam’s club bags (I think there were maybe 8 dollars?) that we bought 5 - 6 years ago. I use these bags a couple of time per week. Use them for the refrigerated/frozen food from the market AND to keep the pizza hot when I run out for pizzas.

Jim

 

[the MfM]

So if we had cashiers pushing groceries to your car the vaccines would be more effective?

No it’s the reusable shopping bags that are the problem…they are a known disease vector.

 

[the MfM]

I gotta say I don’t miss the plastic bags at the market. Here in Delaware we moved away from plastic bags last year. I find the paper bags with the handles to be much superior. Sometimes change is good!

No paper or plastic allowed here. Must bring your own.

 

[Bruce]

I hope that those who spread vaccine misinformation will consider this doctors experience.

 

[Farny]

One death or injury from vaccines is one too many PERIOD.

 

[Farny]

I hope that those who spread vaccine misinformation will consider this doctors experience.