Comirnaty, liability, and how the HHS Conspiracy lies, cheats and steals from the public to hide vaccine injuries and useful treatments
Dear readers, this is a "mistake" substack. My real site is merylnass.substack.com. Nothing more will be added to this site. Please subscribe at the other site.

Meryl Nass
If you receive or use a product that is under an Emergency Use Authorization (EUA), and are injured, you cannot sue the manufacturer, whose liability has been waived by the government. The only possible way to obtain benefits is to apply to the Countermeasures Injury Compensation Program (CICP). This waiver, and the CICP program apply to all EUA products: vaccines, drugs, masks, ventilators, COVID tests, monoclonal antibodies.

When a vaccine is fully licensed, if it has not been placed on the childhood vaccine schedule, you can sue the manufacturer for an injury. A minority of vaccines fall into this category, such as typhoid and cholera vaccines.

There is a second US government program that waives manufacturer liability for those vaccines that have been placed on the childhood schedule. It is called the Vaccine Injury Compensation Program (VICP), and it was established in 1986. All vaccines that CDC recommends for children or pregnant women (and the vast majority of vaccines administered in the US) fall into this category. Both the CICP and VICP programs are administered under the Health Resources and Services Agency (HRSA), a subagency of HHS.

On August 23, 2021, FDA gave Comirnaty a license for people aged 16 and up. And on August 30, 2021, the CDC Advisory Committee on Immunization Practices voted unanimously to put Comirnaty on the childhood schedule, and the CDC Director, Rochelle Walensky, concurred. The USG was able to do this because the vaccine had been licensed for 16-17 year olds, who are still children.

But before Comirnaty can enter the VICP program and gain its liability shield, there must be a 75 cent excise tax imposed on each dose. This money is what supports the VICP awards for injuries. There must also be a notice in the Federal Register. Perhaps surprisingly, neither an excise tax nor a Federal Register notice has been issued for Comirnaty.

I confirmed this by checking whether Cominarty had been formally added to the childhood schedule, and according to the HRSA, which manages both compensation programs, it has not.

So, if you actually received the licensed Comirnaty vaccine, correctly labeled as the brand-name product, and not the EUA Pfizer-BioNTech vaccine being fobbed off as licensed product, and you were injured, you would be free to sue the manufacturer for your injury.

But it seems there is no licensed Comirnaty vaccine anywhere to be found in the US. Pfizer wrote, "Pfizer does not plan to produce any product with these new [Comirnaty National Drug Codes] and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution."

So, if there is no licensed product being administered, and the EUA vaccine is shielded from liability under the CICP, there is no need to finish moving the product into the VICP, yet. The CICP offers stronger liability protection than does the VICP, and its maximum benefit, about $375,000, is a small fraction of the maximal VICP payout. Furthermore, moving the vaccine into the VICP when there isn't any vaccine to be found might create legal risks for the FDA and HHS.

FDA issued a license for Comirnaty in order to enable vaccine mandates, which are illegal for EUA products, since EUA products are by legal definition experimental. (I have cited the EUA laws in earlier blog posts.) Yet FDA knew no licensed vaccine would be offered. This was a crime, a "bait and switch" on the American public. I wrote extensively about it the week of August 23, and in an article in The Defender coauthored with Robert F. Kennedy, Jr. on August 24.

If you received the Pfizer-BioNTech vaccine under Emergency Use Authorization, or received the Moderna (whose branded product, “Spikevax” was licensed on Jan. 31, 2022 but is also unavailable ) or J and J vaccine, you can't sue anyone. You have the right to beg HRSA for compensation for lost wages and unpaid medical bills, period. So far, HRSA and the Countermeasures Injury Compensation Program it administers have not paid out one dime for the approximately one million injuries and 20,000 deaths reported to VAERS for any COVID vaccine, nor a cent for any unreported injuries. In fact, they have not paid out a plug nickel for any injuries due to monoclonal antibodies, remdesivir, other COVID drugs, ventilators, tests, masks etc. that are all being used (a.k.a. shielded) for COVID under the EUA program.

Look at the Countermeasures Injury Compensation Program list of all the payments the CICP has made since it was founded. They have paid out a total of 29 claims since 2010. Over 6,000 (almost all related to COVID products) remain to be adjudicated. Note that the word "alleged" is used for both the countermeasure and the injury for which HRSA provided compensation. Even after HRSA provided benefits, HRSA has not admitted that an injury occurred nor that a countermeasure had caused it.

Table 2. CICP Claims Compensated (Fiscal Years 2010 – 2022) As of November 1, 2021

“This table displays the alleged countermeasure, alleged injury and amount of compensation paid for each compensated CICP claim filed between Fiscal Years 2010 through 2022.”

Total amount paid to all CICP claimants since 2010: $6,076,087.47

DHHS-HRSA have not admitted that a single injury was caused by a COVID vaccine, or for that matter by any COVID product used under an emergency use authorization.

Similarly, CDC says it has not linked a single death to a COVID vaccine--not even when a recipient walked into the vaccination center but got carried out to the morgue.

HRSA, FDA, CDC and NIH are all agencies within the federal Department of Health and Human Services. They have all gotten their stories straight. They know nothing and they are just following orders. This article will provide you with examples of how each of these 4 so-called public health agencies helped hide the truth, instead spreading identical false narratives. It made no difference which party was in power. Heil HHS!

These agencies can't find a doggone problem in the 20 or so databases they are spending many $millions of your money to "study."

Want to know the biggest conspiracy in the US right now? It is the HHS.

FDA and CDC each have their own large sets of databases, about a dozen apiece, most of which they pay industry to access. They share management of the VAERS database, by statute. Why don't they share their other databases, since the taxpayer has already paid for them? One reason is that this gives them a reason to spend more loot, and to point fingers at each other when things aren't going well.

FDA has access to a bunch of electronic databases it has termed the "BEST" Initiative, and it published a plan to use them to study heart attacks, pulmonary embolism, thrombocytopenia, etc. after COVID vaccinations back in July. Where are the results, FDA? What are you waiting for? (According to CDC, "More than 459 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 29, 2021."). It seems clear that we aren't going to be informed of FDA's findings until everyone possible has been vaccinated, at which point the results will be irrelevant.

In October 2020, FDA's head of epidemiology and biostatistics, Steve Anderson, told us there were even more databases that would be studied. Here is what he promised would be studied:


And here is a more recent FDA list of the databases FDA claims it is using to assess COVID vaccine safety, in addition to VAERS, which FDA and CDC jointly share:


There was another system FDA promised to use to evaluate vaccine safety: PRISM. But we have heard nothing from PRISM regarding COVID vaccines, or anything else, lately. PRISM has disappeared.


The Center for Biologics' Office of Biostatistics and Epidemiology currently has 11 fulltime staff and 4 vacancies. Did the honest analysts leave? The other eleven seem to be sitting on their hands. Myocarditis is the most obvious COVID vaccine-associated severe adverse event. It usually happens within 4 days of the second shot. It is most common in young males. It has been reported many thousands of times to VAERS. Understanding it ought to be a slam dunk.

On August 23, 2021, FDA had the temerity to write to BioNTech that its [FDA's] capabilities were inadequate to assess myocarditis, so BioNTech would have to do it for them. Here is what FDA wrote about its inability to use VAERS and its many other databases to assess the myocarditis risk:

As noted above, the FDA acknowledges that “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA [in other words, analyzing VAERS--Nass] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis.

Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA [in other words, FDA's many other databases that cost the taxpayer $zillions are also inadequate--Nass] is not sufficient to assess these serious risks.”

NOT SUFFICIENT???? Is this a joke? All this data, plus software, plus a team of analysts, and FDA says it can't assess the risk of myocarditis, despite identifying thousands of cases?

Unsaid, but implied, is that if FDA is incapable of understanding thousands of reported cases of myocarditis, it cannot or will not study the other serious adverse events that have been reported in conjunction with COVID vaccines.

VAERS has operated for 30 years, collecting reports of vaccine adverse events. It averaged under 100 cases of myocarditis reported yearly until this year. Through November, CDC reports it received 1949 reports of myocarditis and pericarditis, just in those under 30. CDC didn't say what the total number of reports for all ages was.

Somehow, FDA and CDC don't seem at all perturbed that the acknowledged reporting rate of myocarditis is over 20 times the average during the past 30 years. Why not?

CDC has been even more shady in its analyses of safety as FDA, if that is even possible. Below, Nancy Messonier, then head of Immunizations and Respiratory Diseases at CDC, presented this list of databases that CDC would be using in the evaluation of COVID vaccine safety, on December 10, 2020. Apart from the V-safe database (which they stopped talking about last January, after it revealed that 1-3% of vaccine recipients required a doctor visit to deal with side effects), the Vaccine Safety Datalink (VSD) (which somehow can't find any problems, not even myocarditis) and the VAERS database, all the other databases CDC promised to study have been MIA.


NIH, whose job has never been to issue treatment guidelines, but instead to perform and fund research, suddenly took over the treatment guidelines for COVID early in 2020. It formed a committee of internal and eternal "experts" to make up the guidelines. How were they chosen? That is not clear, but what is clear is that 16 of these so-called experts had current or recent financial entanglements with Gilead, the maker of remdesivir. NIH and the US Army also owned pieces of remdesivir. A number of the experts had financial dealings with Merck. While NIH is the single biggest funder of medical research in the world, I cannot recall seeing a single study it funded on the safety of COVID vaccines. Yet somehow vaccines are its number one recommendation.

It is not clear whether the NIH's guidelines committee is functional. The NIH has been sued to learn whether a vote was even taken by the committee regarding its ivermectin guidelines, which fly in the face of the evidence on ivermectin. And no one has answered the big question: how was NIH somehow authorized to issue treatment guidelines in the first place?

Here is what has obviously occurred. All these agencies were told they had to keep quiet on vaccine problems (and perhaps problems of other COVID treatments), and they had to fiddle with their data or their analytic methods, or both, to get the required results. And there was to be NO BAD NEWS, no matter what. And no good news regarding generic treatments.

As we have seen, the so-called scientists and physicians working as bureaucrats in these agencies all caved, sucked it up, did the dirty work, kept their jobs, and betrayed their oaths and the trust of the people of the USA and the world.

Here is one example of their gross perfidy:
Rochelle Walensky, MD, MPH

@CDCDirector

#COVID19 vaccines are safe for children 5-11. They have undergone the most comprehensive & intense safety monitoring system in U.S. history. To date, no serious safety concerns have been identified. Vaccination is the best way to protect children from COVID-19. Dec. 10

Yet here is what her own agency found 6 months ago:


And in Hong Kong, health authorities found one case of myocarditis in every 2700 boys aged 12-17 after their second shot. Apparently CDC Director Walensky thinks that is safe. Is she really a doctor?

It is important to call out the criminals. I hope everyone knows HHS gave the CDC Director's husband's company a $5 million dollar contract in taxpayer money, with options for $12 million more, presumably if she behaves herself... at our expense.


https://meryl.substack.com/p/how-4-hhs-agencies-conspire-to-lie


https://donshafi911sars-cov-2.blogspot.com/2024/07/comirnaty-liability-and-how-hhs.html
Comirnaty, liability, and how the HHS Conspiracy lies, cheats and steals from the public to hide vaccine injuries and useful treatments Dear readers, this is a "mistake" substack. My real site is merylnass.substack.com. Nothing more will be added to this site. Please subscribe at the other site. Meryl Nass If you receive or use a product that is under an Emergency Use Authorization (EUA), and are injured, you cannot sue the manufacturer, whose liability has been waived by the government. The only possible way to obtain benefits is to apply to the Countermeasures Injury Compensation Program (CICP). This waiver, and the CICP program apply to all EUA products: vaccines, drugs, masks, ventilators, COVID tests, monoclonal antibodies. When a vaccine is fully licensed, if it has not been placed on the childhood vaccine schedule, you can sue the manufacturer for an injury. A minority of vaccines fall into this category, such as typhoid and cholera vaccines. There is a second US government program that waives manufacturer liability for those vaccines that have been placed on the childhood schedule. It is called the Vaccine Injury Compensation Program (VICP), and it was established in 1986. All vaccines that CDC recommends for children or pregnant women (and the vast majority of vaccines administered in the US) fall into this category. Both the CICP and VICP programs are administered under the Health Resources and Services Agency (HRSA), a subagency of HHS. On August 23, 2021, FDA gave Comirnaty a license for people aged 16 and up. And on August 30, 2021, the CDC Advisory Committee on Immunization Practices voted unanimously to put Comirnaty on the childhood schedule, and the CDC Director, Rochelle Walensky, concurred. The USG was able to do this because the vaccine had been licensed for 16-17 year olds, who are still children. But before Comirnaty can enter the VICP program and gain its liability shield, there must be a 75 cent excise tax imposed on each dose. This money is what supports the VICP awards for injuries. There must also be a notice in the Federal Register. Perhaps surprisingly, neither an excise tax nor a Federal Register notice has been issued for Comirnaty. I confirmed this by checking whether Cominarty had been formally added to the childhood schedule, and according to the HRSA, which manages both compensation programs, it has not. So, if you actually received the licensed Comirnaty vaccine, correctly labeled as the brand-name product, and not the EUA Pfizer-BioNTech vaccine being fobbed off as licensed product, and you were injured, you would be free to sue the manufacturer for your injury. But it seems there is no licensed Comirnaty vaccine anywhere to be found in the US. Pfizer wrote, "Pfizer does not plan to produce any product with these new [Comirnaty National Drug Codes] and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution." So, if there is no licensed product being administered, and the EUA vaccine is shielded from liability under the CICP, there is no need to finish moving the product into the VICP, yet. The CICP offers stronger liability protection than does the VICP, and its maximum benefit, about $375,000, is a small fraction of the maximal VICP payout. Furthermore, moving the vaccine into the VICP when there isn't any vaccine to be found might create legal risks for the FDA and HHS. FDA issued a license for Comirnaty in order to enable vaccine mandates, which are illegal for EUA products, since EUA products are by legal definition experimental. (I have cited the EUA laws in earlier blog posts.) Yet FDA knew no licensed vaccine would be offered. This was a crime, a "bait and switch" on the American public. I wrote extensively about it the week of August 23, and in an article in The Defender coauthored with Robert F. Kennedy, Jr. on August 24. If you received the Pfizer-BioNTech vaccine under Emergency Use Authorization, or received the Moderna (whose branded product, “Spikevax” was licensed on Jan. 31, 2022 but is also unavailable ) or J and J vaccine, you can't sue anyone. You have the right to beg HRSA for compensation for lost wages and unpaid medical bills, period. So far, HRSA and the Countermeasures Injury Compensation Program it administers have not paid out one dime for the approximately one million injuries and 20,000 deaths reported to VAERS for any COVID vaccine, nor a cent for any unreported injuries. In fact, they have not paid out a plug nickel for any injuries due to monoclonal antibodies, remdesivir, other COVID drugs, ventilators, tests, masks etc. that are all being used (a.k.a. shielded) for COVID under the EUA program. Look at the Countermeasures Injury Compensation Program list of all the payments the CICP has made since it was founded. They have paid out a total of 29 claims since 2010. Over 6,000 (almost all related to COVID products) remain to be adjudicated. Note that the word "alleged" is used for both the countermeasure and the injury for which HRSA provided compensation. Even after HRSA provided benefits, HRSA has not admitted that an injury occurred nor that a countermeasure had caused it. Table 2. CICP Claims Compensated (Fiscal Years 2010 – 2022) As of November 1, 2021 “This table displays the alleged countermeasure, alleged injury and amount of compensation paid for each compensated CICP claim filed between Fiscal Years 2010 through 2022.” Total amount paid to all CICP claimants since 2010: $6,076,087.47 DHHS-HRSA have not admitted that a single injury was caused by a COVID vaccine, or for that matter by any COVID product used under an emergency use authorization. Similarly, CDC says it has not linked a single death to a COVID vaccine--not even when a recipient walked into the vaccination center but got carried out to the morgue. HRSA, FDA, CDC and NIH are all agencies within the federal Department of Health and Human Services. They have all gotten their stories straight. They know nothing and they are just following orders. This article will provide you with examples of how each of these 4 so-called public health agencies helped hide the truth, instead spreading identical false narratives. It made no difference which party was in power. Heil HHS! These agencies can't find a doggone problem in the 20 or so databases they are spending many $millions of your money to "study." Want to know the biggest conspiracy in the US right now? It is the HHS. FDA and CDC each have their own large sets of databases, about a dozen apiece, most of which they pay industry to access. They share management of the VAERS database, by statute. Why don't they share their other databases, since the taxpayer has already paid for them? One reason is that this gives them a reason to spend more loot, and to point fingers at each other when things aren't going well. FDA has access to a bunch of electronic databases it has termed the "BEST" Initiative, and it published a plan to use them to study heart attacks, pulmonary embolism, thrombocytopenia, etc. after COVID vaccinations back in July. Where are the results, FDA? What are you waiting for? (According to CDC, "More than 459 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through November 29, 2021."). It seems clear that we aren't going to be informed of FDA's findings until everyone possible has been vaccinated, at which point the results will be irrelevant. In October 2020, FDA's head of epidemiology and biostatistics, Steve Anderson, told us there were even more databases that would be studied. Here is what he promised would be studied: And here is a more recent FDA list of the databases FDA claims it is using to assess COVID vaccine safety, in addition to VAERS, which FDA and CDC jointly share: There was another system FDA promised to use to evaluate vaccine safety: PRISM. But we have heard nothing from PRISM regarding COVID vaccines, or anything else, lately. PRISM has disappeared. The Center for Biologics' Office of Biostatistics and Epidemiology currently has 11 fulltime staff and 4 vacancies. Did the honest analysts leave? The other eleven seem to be sitting on their hands. Myocarditis is the most obvious COVID vaccine-associated severe adverse event. It usually happens within 4 days of the second shot. It is most common in young males. It has been reported many thousands of times to VAERS. Understanding it ought to be a slam dunk. On August 23, 2021, FDA had the temerity to write to BioNTech that its [FDA's] capabilities were inadequate to assess myocarditis, so BioNTech would have to do it for them. Here is what FDA wrote about its inability to use VAERS and its many other databases to assess the myocarditis risk: As noted above, the FDA acknowledges that “We have determined that an analysis of spontaneous post-marketing adverse events reported under section 505(k)(1) of the FDCA [in other words, analyzing VAERS--Nass] will not be sufficient to assess known serious risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical myocarditis. Furthermore, the pharmacovigilance system that FDA is required to maintain under section 505(k)(3) of the FDCA [in other words, FDA's many other databases that cost the taxpayer $zillions are also inadequate--Nass] is not sufficient to assess these serious risks.” NOT SUFFICIENT???? Is this a joke? All this data, plus software, plus a team of analysts, and FDA says it can't assess the risk of myocarditis, despite identifying thousands of cases? Unsaid, but implied, is that if FDA is incapable of understanding thousands of reported cases of myocarditis, it cannot or will not study the other serious adverse events that have been reported in conjunction with COVID vaccines. VAERS has operated for 30 years, collecting reports of vaccine adverse events. It averaged under 100 cases of myocarditis reported yearly until this year. Through November, CDC reports it received 1949 reports of myocarditis and pericarditis, just in those under 30. CDC didn't say what the total number of reports for all ages was. Somehow, FDA and CDC don't seem at all perturbed that the acknowledged reporting rate of myocarditis is over 20 times the average during the past 30 years. Why not? CDC has been even more shady in its analyses of safety as FDA, if that is even possible. Below, Nancy Messonier, then head of Immunizations and Respiratory Diseases at CDC, presented this list of databases that CDC would be using in the evaluation of COVID vaccine safety, on December 10, 2020. Apart from the V-safe database (which they stopped talking about last January, after it revealed that 1-3% of vaccine recipients required a doctor visit to deal with side effects), the Vaccine Safety Datalink (VSD) (which somehow can't find any problems, not even myocarditis) and the VAERS database, all the other databases CDC promised to study have been MIA. NIH, whose job has never been to issue treatment guidelines, but instead to perform and fund research, suddenly took over the treatment guidelines for COVID early in 2020. It formed a committee of internal and eternal "experts" to make up the guidelines. How were they chosen? That is not clear, but what is clear is that 16 of these so-called experts had current or recent financial entanglements with Gilead, the maker of remdesivir. NIH and the US Army also owned pieces of remdesivir. A number of the experts had financial dealings with Merck. While NIH is the single biggest funder of medical research in the world, I cannot recall seeing a single study it funded on the safety of COVID vaccines. Yet somehow vaccines are its number one recommendation. It is not clear whether the NIH's guidelines committee is functional. The NIH has been sued to learn whether a vote was even taken by the committee regarding its ivermectin guidelines, which fly in the face of the evidence on ivermectin. And no one has answered the big question: how was NIH somehow authorized to issue treatment guidelines in the first place? Here is what has obviously occurred. All these agencies were told they had to keep quiet on vaccine problems (and perhaps problems of other COVID treatments), and they had to fiddle with their data or their analytic methods, or both, to get the required results. And there was to be NO BAD NEWS, no matter what. And no good news regarding generic treatments. As we have seen, the so-called scientists and physicians working as bureaucrats in these agencies all caved, sucked it up, did the dirty work, kept their jobs, and betrayed their oaths and the trust of the people of the USA and the world. Here is one example of their gross perfidy: Rochelle Walensky, MD, MPH @CDCDirector #COVID19 vaccines are safe for children 5-11. They have undergone the most comprehensive & intense safety monitoring system in U.S. history. To date, no serious safety concerns have been identified. Vaccination is the best way to protect children from COVID-19. Dec. 10 Yet here is what her own agency found 6 months ago: And in Hong Kong, health authorities found one case of myocarditis in every 2700 boys aged 12-17 after their second shot. Apparently CDC Director Walensky thinks that is safe. Is she really a doctor? It is important to call out the criminals. I hope everyone knows HHS gave the CDC Director's husband's company a $5 million dollar contract in taxpayer money, with options for $12 million more, presumably if she behaves herself... at our expense. https://meryl.substack.com/p/how-4-hhs-agencies-conspire-to-lie https://donshafi911sars-cov-2.blogspot.com/2024/07/comirnaty-liability-and-how-hhs.html
MERYL.SUBSTACK.COM
Comirnaty, liability, and how the HHS Conspiracy lies, cheats and steals from the public to hide vaccine injuries and useful treatments
Dear readers, this is a "mistake" substack. My real site is merylnass.substack.com. Nothing more will be added to this site. Please subscribe at the other site.
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