Latest vaccine flip-flop gives the vaccine game away

The Venous Sinus System, where slow blood flow apparently predisposes to clots after the Astra-Zeneca Covid vaccination

The Astra-Zeneca "cheap and easy to store" "workhorse" vaccine causes blood clots in general, and in particular clots in the venous sinuses of the brain, which have killed or wounded a number of people, especially women under 55.  

From StatNews:

Disorders caused by blood clots, including heart attacks, vein thromboses, and strokes, are common. But the types of clots that may be linked to the AstraZeneca vaccine are exceedingly rare. They have been marked by low levels of platelets — the blood cell fragments that normally cause clotting. 

The types of clots seen include cerebral venous sinus thrombosis, or CVST, a type of blood clot that occurs in the veins that drain blood from the brain, and a similar condition in the abdomen, known as splanchic vein thrombosis. The clots sometimes occur in combination with bleeding.

From the Washington Post:

The European Medicines Agency, the European Union’s regulator, said it is investigating at least 44 cases of the rare brain clots and at least 14 deaths among about 9.2 million vaccinations in 30 European countries...

As of March 29, Germany’s regulator has reported 31 cases of the unusual blood clots in 2.7 million people vaccinated with the AstraZeneca vaccine, nine of whom have died.

The J and J vaccine was also associated with blood clots in the clinical trial data presented to FDA.  Both vaccines use an adenovirus vector to deliver DS DNA that codes for spike protein, and human cellular machinery produces this protein, for an uncertain period of time in uncertain quantities. So blood clotting may be due to the adenovirus vector, or to the spike protein, or to something entirely different.

The mRNA vaccines use mRNA to code for the spike, also using cellular machinery to produce the spike protein.  The end result of all 4 vaccines is similar, and again, we do not know for how long the body makes this protein.

If the spike itself induces clotting, which is a reasonable hypothesis scientists have put forth, but is unproven, then all 4 vaccines would be thrombogenic (induce clotting). Dr. Patrick Whelan tried to warn the FDA about this possibility, but was ignored.  He wrote:

Meinhardt et al. (Nature Neuroscience 2020, in press) show that the spike protein in brain endothelial cells is associated with formation of microthrombi (clots), and like Magro et al. do not find viral RNA in brain endothelium. In other words, viral proteins appear to cause tissue damage without actively replicating virus.

Is it possible the spike protein itself causes the tissue damage associated with Covid-19? Nuovo et al (in press) have shown that in 13/13 brains from patients with fatal COVID-19, pseudovirions (spike, envelope, and membrane proteins) without viral RNA are present in the endothelia of cerebral microvessels.

This is frightening information, providing a strong hint of the spike protein's potential toxicity. 

--------------

From StatNews:

Many countries are counting on AstraZeneca’s vaccine. The European Union alone has purchased 400 million doses of the vaccine. The United States has bought 300 million doses of the vaccine, the largest pre-purchase deal of all those contracted by Operation Warp Speed...

How did 20 countries deal with the clotting issue?

First they halted the vaccinations until they could review all the available data and get their narratives aligned. They then decided the A-Z vaccine did cause clots.  But you cannot waste Covid vaccine (unless you are Emergent BioSolutions) so it had to be used.  But in whom?  In poorer countries of course.  But what about the supplies already purchased by western Europe?

The public health leaders came up with a great idea.  Restrict it, just for the elderly.  If they die, there is almost always a preexisting condition to blame. 

But apparently that wasn't sufficient.  So they started testing this vaccine in children. 

A few countries stopped the A-Z vaccine altogether.

France, Germany, Sweden and Canada are among those restricting its use in younger people, while Denmark and Norway have maintained a complete pause.

What about the US?  Despite the problems with EBS's failed production of the Johnson and Johnson/Janssen vaccine (up to 150 million doses may need to be thrown away) the US seems to be swimming in vaccine at the moment, and any adult can sign up for a dose. It is likely that Astra-Zeneca's 300 million doses purchased by the US government will be written off, in addition to the failed J and J doses.

From StatNews:

Whether it will be used here remains an open question. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told Reuters last week that the U.S. may not need the vaccine.

“My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca,” Fauci said, without referring to the clotting problem now associated with the vaccine.

Can you imagine what the informed consent for the Oxford A-Z clinical trial in children says?  "We are testing a vaccine known to cause lethal blood clots, in children, who almost never get severe Covid--therefore the benefits won't exceed the risks of the vaccine in this demographic.  Your child is at greater risk of dying from the vaccine than the disease."  How many parents would sign?  The consent form necessarily must be a dishonest document.  Here is a legal case for you British barristers.

As I was writing this, the news appeared that the clinical trials of the A-Z vaccine in children were finally paused, just today. Which is several weeks after the blood clotting issue surfaced.

How well does the Astra-Zeneca vaccine work in the elderly?  Only two months ago the leaders of France and Germany told us:  

Officials in Germany claim the Astra-Zeneca vaccine  is only 8% effective in those over 65. French President Macron has complained to Agence France Press that the A-Z vaccine was only "quasi-ineffective for people over 65."

So, in order to use up the supply, or perhaps for other purposes, Germany will now use the vaccine only in those over 60, and France will use it only in those over 55 -- which are the age groups in which they claimed it didn't work.

In case it is not yet clear, this latest flip-flop from Macron and Merkel (who announced the German restrictions) reveals the truth.  The purpose of the vaccines is obviously not to protect us. 

The vaccines enrich Pharma. The vaccine passports enable much greater control over the citizenry. There may be additional agendas.  

But this is clearly not about our health. 

UPDATE April 7:  A reader pointed out this article in the comments, which provides experimental evidence that spike protein activates platelets and enhances blood clotting. It was published in September, and 20,000 people have accessed it online.  I'd wager that  all the vaccine safety experts at the FDA, EMA and WHO have read it.  Their silence about the potential for thrombosis inherent in all the spike protein-based vaccines has been deafening. Certainly no one mentioned this information at any of the VRBPAC meetings, held to authorize the Covid vaccines.

• Published: 04 September 2020

SARS-CoV-2 binds platelet ACE2 to enhance thrombosis in COVID-19

• Si Zhang, 
• Yangyang Liu, 
• Xiaofang Wang, 
• Li Yang, 
• Haishan Li, 
• Yuyan Wang, 
• Mengduan Liu, 
• Xiaoyan Zhao, 
• Youhua Xie, 
• Yan Yang, 
• Shenghui Zhang, 
• Zhichao Fan, 
• Jianzeng Dong, 
• Zhenghong Yuan, 
• Zhongren Ding, 
• Yi Zhang & 
• Liang Hu 

Journal of Hematology & Oncology volume 13, Article number: 120 (2020) Cite this article

• 20k Accesses

• 34 Citations

• 490 Altmetric

• Metricsdetails

Abstract

Background

Critically ill patients diagnosed with COVID-19 may develop a pro-thrombotic state that places them at a dramatically increased lethal risk. Although platelet activation is critical for thrombosis and is responsible for the thrombotic events and cardiovascular complications, the role of platelets in the pathogenesis of COVID-19 remains unclear.

Methods

Using platelets from healthy volunteers, non-COVID-19 and COVID-19 patients, as well as wild-type and hACE2 transgenic mice, we evaluated the changes in platelet and coagulation parameters in COVID-19 patients. We investigated ACE2 expression and direct effect of SARS-CoV-2 virus on platelets by RT-PCR, flow cytometry, Western blot, immunofluorescence, and platelet functional studies in vitro, FeCl3-induced thrombus formation in vivo, and thrombus formation under flow conditions ex vivo.

Results

We demonstrated that COVID-19 patients present with increased mean platelet volume (MPV) and platelet hyperactivity, which correlated with a decrease in overall platelet count. Detectable SARS-CoV-2 RNA in the blood stream was associated with platelet hyperactivity in critically ill patients. Platelets expressed ACE2, a host cell receptor for SARS-CoV-2, and TMPRSS2, a serine protease for Spike protein priming. SARS-CoV-2 and its Spike protein directly enhanced platelet activation such as platelet aggregation, PAC-1 binding, CD62P expression, α granule secretion, dense granule release, platelet spreading, and clot retraction in vitro, and thereby Spike protein enhanced thrombosis formation in wild-type mice transfused with hACE2 transgenic platelets, but this was not observed in animals transfused with wild-type platelets in vivo. Further, we provided evidence suggesting that the MAPK pathway, downstream of ACE2, mediates the potentiating role of SARS-CoV-2 on platelet activation, and that platelet ACE2 expression decreases following SARS-COV-2 stimulation. SARS-CoV-2 and its Spike protein directly stimulated platelets to facilitate the release of coagulation factors, the secretion of inflammatory factors, and the formation of leukocyte–platelet aggregates. Recombinant human ACE2 protein and anti-Spike monoclonal antibody could inhibit SARS-CoV-2 Spike protein-induced platelet activation.

Conclusions

Our findings uncovered a novel function of SARS-CoV-2 on platelet activation via binding of Spike to ACE2. SARS-CoV-2-induced platelet activation may participate in thrombus formation and inflammatory responses in COVID-19 patients.

Cerebral sinus thromboses associated with thrombocytopenia--very rare--after Astra-Zeneca (Oxford) Covid vaccine

Let me explain.  Cavernous sinus thrombosis is a very rare condition that often leads to death.  Suddenly cases are popping up right after vaccination.  This is not a garden variety blood clot.  This is a clot of the major vein that drains blood from your brain.  While the media say, "Blood clots are common" this condition is rare and its association with vaccination is notable.  Furthermore, in one of the clinical trials for another Covid vaccine, excess blood clots were seen as well--so blood clots may have something to do with the spike protein, the main immunogen all the vaccines share. I also saw lots of blood clots occurring in young peole after anthrax vaccine, some of whom developed antiphospholipid antibody syndrome.

Update March 18: in The Defender:

Germany’s Health Minister, Jens Spahn, acted on expert advice after Germany’s vaccine oversight body, the Paul Ehrlich Institute, reported on what it described as a statistically significant number of cases of a rare brain blood clot. A “chaotic round of telephone diplomacy” ended with the EU’s biggest states agreeing to put AstraZeneca on hold, reported Reuters.

------------------------------------------------------------------

"The Paul-Ehrlich-In­sti­tut in­forms - Tem­po­rary 

Sus­pen­sion of Vac­ci­na­tion with COVID-19 Vac­cine 

As­tra Zeneca

https://www.pei.de/EN/newsroom/hp-news/2021/210315-pei-informs-temporary-suspension-vaccination-astra-zeneca.html

Following intensive consultations on the serious thrombotic events that have occurred in Germany and Europe, the Paul-Ehrlich-Institut recommends the temporary suspension of vaccinations with the COVID-19 vaccine AstraZeneca.

Compared to the status on 11 March 2021, additional cases (as of Monday, 15 March 2021) have now been reported in Germany. Analysing the new data status, the experts of the Paul-Ehrlich-Institut now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in connection with a deficiency of blood platelets (thrombocytopenia) and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine AstraZeneca.

The data are being further analysed and evaluated by the European Medicines Agency (EMA).

Vaccinations with AstraZeneca's COVID-19 vaccine in Germany will be suspended until the EMA's evaluation is complete. Today's decision affects both initial and follow-up vaccinations.

The Paul-Ehrlich-Institut advises that individuals who have received AstraZeneca's COVID-19 vaccine and feel increasingly unwell more than four days after vaccination - for example, with severe and persistent headache or pinpoint bleeding of the skin - should seek medical treatment immediately."

Updated: 15.03.2021

Fifteen Countries have halted Astra-Zeneca Covid Vaccinations

Thailand for some reason changed its mind and is now allowing the A-Z vaccine to be used.  But two additional European countries (13 total) and Indonesia and Iran have now said "No thanks."   

The Astra-Zeneca/ Oxford vaccine (remember, the one that was supposed to be given to the world without profit, until supposedly the BMGF convinced its developers to sell to the highest bidder), the one that uses a chimpanzee adenovirus as the vector for Spike DNA, and was associated with some severe neurologic injuries in subjects in its clinical trial, has now been "halted" in ten countries.

Kaiser Health News described the original promise not to profit:

The idea was to provide medicines preventing or treating COVID-19 at a low cost or free of charge, the British university said. That made sense to people seeking change. The coronavirus was raging. Many agreed that traditional vaccine development, characterized by long lead times, manufacturing monopolies and weak investment, was broken.

“We actually thought they were going to do that,” James Love, director of Knowledge Ecology International, a nonprofit that works to expand access to medical technology, said of Oxford’s pledge. “Why wouldn’t people agree to let everyone have access to the best vaccines possible?”

A few weeks later, Oxford—urged on by the Bill & Melinda Gates Foundation—reversed course. It signed an exclusive vaccine deal with AstraZeneca that gave the pharmaceutical giant sole rights and no guarantee of low prices—with the less-publicized potential for Oxford to eventually make millions from the deal and win plenty of prestige.

At least 9 European countries halt the Astra-Zeneca Oxford vaccine

BMJ March 10, 2021--at least 9 European countries have suspended some or all of the Astra-Zeneca vaccine

Denmark, Norway, Austria, Estonia, Latvia, Lithuania and Luxembourg have halted some or all of their AstraZeneca COVID-19 vaccinations over fears of blood clots, France24 reports.

Denmark became at least the sixth European country to scale back the use of AstraZeneca’s COVID-19 vaccine after some people who received it developed blood clots. 

Austria suspends AstraZeneca COVID-19 vaccine batch after death

ZURICH (Reuters) - Austrian authorities have suspended inoculations with a batch of AstraZeneca’s COVID-19 vaccine as a precaution while investigating the death of one person and the illness of another after the shots, a health agency said on Sunday...

One 49-year-old woman died as a result of severe coagulation disorders, while a 35-year-old woman developed a pulmonary embolism and is recovering, it said. A pulmonary embolism is an acute lung disease caused by a dislodged blood clot.

Italy bans AstraZeneca batch following two deaths in Sicily: source March 11 Reuters

White House to SHARE its Emergent BioSolutions, unusable Astra-Zeneca vaccine with other nations

From today's WaPo:

Of Americans not yet vaccinated, fewer than 1 in 4 people said they would be willing to get the Johnson & Johnson vaccine, a Washington Post-ABC News poll found. Confidence in the other two vaccines remained high.

Emergent Solutions, which has been beaten and bloodied by the Washington Post and NY Times over the past few weeks, and continues to fail FDA inspections, is the ONLY source of Johnson and Johnson Covid vaccine produced in the US.  It is also the only source of Astra-Zeneca Covid vaccine produced in the US.  Only the uninformed would accept either product from Emergent BioSolutions' stocks.  What can be done about that?

Dump this unapproved, unauthorized and potentially contaminated vaccine on other countries, like India, of course. 

The White House also announced Monday that the United States will share up to 60 million doses of the AstraZeneca vaccine with other countries. That vaccine has not been authorized for use in the United States but has been available in countries such as the U.K. for months...

The AstraZeneca vaccine, which is not yet authorized for use in the U.S. by the Food and Drug Administration, will be sent to other countries once it clears federal safety reviews, officials said...We do not need to use AstraZeneca in our fight against covid,” White House press secretary Jen Psaki told reporters... 

The situation in India, where record global daily covid-19 cases have been set in recent days, is especially dire... 

UPDATE May 1:  Health Canada is not distributing the Emergent BioSolutions-made Johnson and Johnson Covid vaccines.  

 

 

Biden administration puts J and J in charge of the Emergent BioSolutions vaccine plant, and cancels Emergent's Astra-Zeneca vaccine production

Finally the Biden administration is getting serious about Emergent BioSolutions' Covid vaccine-making.  I hope they have finally understood that this is not a company that  plays by the rules.  This is a company that has turned repeat failures into a multi-billion dollar business.  Emergent succeeds by failing.  How much extra money will Emergent receive as a result of this contract modification?  How much will the taxpayers have to foot?  

UPDATE April 5:  It took a week of negotiation to arrange for J and J to manage the Emergent factory, and to move out the A-Z vaccine. Why a week?  Because Emergent had to come out of its failure with lots of extra money. Mark my words. From the WaPo:

A senior administration official, who spoke on the condition of anonymity to discuss the sensitive matter, said health officials had negotiated for more than a week for an arrangement, announced late Saturday, under which Johnson & Johnson would take over responsibility for manufacturing at the plant.

From today's NY Times:

The Biden administration on Saturday put Johnson & Johnson in charge of a Baltimore contract plant that ruined 15 million doses of its Covid-19 vaccine, and moved to stop the facility from making another vaccine, developed by AstraZeneca, senior federal health officials said.

The extraordinary move by the Department of Health and Human Services will leave the Emergent BioSolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mix-ups, according to two senior federal health officials. Johnson & Johnson confirmed the changes, saying it was “assuming full responsibility” for the vaccine made by Emergent.

The change came in response to the recent disclosure that Emergent, a manufacturing partner to both AstraZeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plant’s production lines.

Federal officials are worried that the mix-up will erode public confidence in the vaccines, just as President Biden is making an aggressive push to have enough vaccine doses to cover every American adult by the end of May. At the same time, there is deep concern about the safety of the AstraZeneca vaccine, amid a health scare that has prompted some European countries to restrict its use...

Experts in vaccine manufacturing said that in the past, the Food and Drug Administration had a rule to prevent such mishaps by not allowing a facility to make two live viral vector vaccines, because of the potential for mix-ups and contamination...

UPDATE April 5: from Fierce Pharma, it is starting to look like the US government may jettison the Astra-Zeneca Covid vaccine.  After all, who would take it, given what is known about brain blood clots from its European rollout?

"With the Biden administration ordering Johnson & Johnson to take over an error-prone Emergent BioSolutions plant in Baltimore, AstraZeneca needs to secure new manufacturing capacity. The United States will assist in that search.
AstraZeneca is working with the government's Biomedical Advanced Research and Development Authority to “maximize and accelerate US production of COVID-19 vaccines,” the company said in a statement.  
Emergent’s Baltimore-Bayview facility had been helping with vaccine production for AstraZeneca. Another CDMO, Catalent, is helping to produce the shot for the British drugmaker at another plant in Baltimore. 

AstraZeneca has agreed to supply the U.S. with 300 million vaccine doses, but last week NIAID Director Anthony Fauci said supply from the company may not be necessary to vaccinate the population.

What you need to know about experimental Covid vaccines, the law and the science

1.  Are Americans who receive vaccines under EUA experimental subjects?

·       Definitely yes.  An EUA product is not a law unto itself.  According to 21CFR Subchapter D Part 312:  "an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice."

·       Medicines and vaccines are either licensed products or experimental products. There is no gray area between them in US law. Whether or not research is explicitly conducted, the use of experimental products (including those issued under an Emergency Use Authorization) falls under the Nuremberg Code and under US law regulating experimental drugs. 

·       Vaccines are drugs under FDA law:  "[V]accines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product," according to Marion Gruber, the current Director of FDA's Office of Vaccines Research and Review.

2.  US regulations (45 CFR 46 Subpart A) for the use of experimental products require:

a.     informed consent, in which there must be full disclosure of risks and benefits of the product and the absence of coercion, and 

b.     approval by an Institutional Review Board. 

·      Neither of these requirements have been met for Covid-19 vaccines supplied to Americans by the US government, even for civilians. This suggests that the federal government may be trying to carve out a gray area in which the laws governing investigational products do not apply.

3.  While the Nuremberg Code is not officially part of the US Code, it is important to remember that it was formulated by American judges at the Nazi Doctors Trial.  It has subsequently been interpreted to have the force of law by US judges. According to the New England Journal of Medicine:

·       "[Nuremberg's] basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966).^6,22 Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).²³ ...Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations." 

4.  What information do we have regarding the safety, efficacy, necessity and manufacturing fidelity of the 3 Covid-19 vaccines currently authorized under EUAs and those expected to be authorized?

·      Safety:  2,216 deaths have been reported to a passive reporting system, VAERS, as of March 22.  CDC says it does not have a method for tracking deaths following vaccination, since most of its safety surveillance relies on vaccines administered within the healthcare system. According to MSN, "The struggle to find a way to complete the key vaccination mortality study highlights a growing frustration among officials working on the pandemic response that the federal government is still falling short in collecting, analyzing, and reporting of COVID-19 data." 

·      Yet CDC has assured the public that not a single death has been shown to be due to a vaccination. According to Elisabeth Rosenthal in the LA Times, "we still don't have a uniform national digital database that can track who is getting the vaccine." The bottom line is that we don't have the safety data we need, after over 100 million doses of unlicensed vaccines have been administered.

·      Meanwhile, the Astra-Zeneca vaccine has been found to cause serious, rare blood clots, especially in the brain, in perhaps one in 25,000 young recipients.

·      Data adequacy:  The Emergency Use Authorizations for the Covid-19 vaccines were issued with only a median of 2 months of data.  Only two months.  While the trials were originally expected to continue for 2 years, when vaccine became publicly available, the vaccine manufacturers offered vaccine to the subjects in their trials who had received placebos. Thus, the anticipated datasets from the clinical trials, in which placebo recipients would be compared to vaccine recipients in terms of long-term side effects and infection rates for 2 years, will be greatly abbreviated.  

·       According to Brownlee and Lenzer, "A decision [was] made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will." 

·      Efficacy:  We still do not know to what extent the vaccines are efficacious and to what extent they prevent transmission, both to current strains of Covid-19 and to newer variants

      Manufacturing fidelity:  The FDA is not required to inspect manufacturers of EUA products, as it is for licensed products.  Whether Good Manufacturing Practices are met is uncertain.  Emergent BioSolutions, which is the subcontractor for the production of the Johnson and Johnson, Astra-Zeneca and Novavax Covid-19 vaccines for the US market, continues to face delays receiving authorization from FDA for its J and J vaccine. This is the company that produces all US anthrax vaccine.  Furthermore, the DHHS Secretary has the authority to waive Good Manufacturing Practice (GMP) requirements for EUA products, and GMP waivers have been issued for other Covid-19 EUA products.

The law on Emergency Use Authorized (EUA = experimental, investigational) products

* I wrote the following on March 29, 2021.  It is important for those fighting vaccine mandates under EUA to understand the legal background for EUAs. 

1.  Are Americans who receive vaccines under EUA experimental subjects?

·      Definitely yes.  An EUA product is not a law unto itself.  According to 21CFR Subchapter D Part 312:  "an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

EUA products are still considered investigational," FDA Commissioner Stephen Hahn told USA Today.

·  Medicines and vaccines are either licensed products or experimental products. There is no gray area between them in US law. Whether or not research is explicitly conducted, the use of experimental products (including those issued under an Emergency Use Authorization) falls under the Nuremberg Code and under US law regulating experimental drugs.  

·  Vaccines are drugs under FDA law:  "[V]accines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product," according to Marion Gruber, the current Director of FDA's Office of Vaccines Research and Review.

2.  US regulations (45 CFR 46 Subpart A) for the use of experimental products require:

•  informed consent, in which there must be full disclosure of risks and benefits of the product and the absence of coercion, and 
• approval by an Institutional Review Board.   

·      Neither of these requirements have been met for Covid-19 vaccines supplied to Americans by the US government, even for civilians. This suggests that the federal government may be trying to carve out a gray area in which the laws governing investigational products do not apply.

3.  While the Nuremberg Code is not officially part of the US Code, it is important to remember that it was formulated by American judges at the Nazi Doctors Trial.  It has subsequently been interpreted to have the force of law by US judges. According to the New England Journal of Medicine:

      "[Nuremberg's] basic requirement of informed consent, for example, has been universally accepted and is articulated in international law in Article 7 of the United Nations International Covenant on Civil and Political Rights (1966).^6,22 Informed consent, with specific reliance on the Nuremberg Code, is also the basis of the International Ethical Guidelines for Biomedical Research Involving Human Subjects, the most recent guidelines promulgated by the World Health Organization and the Council for International Organizations of Medical Sciences (1993).²³ ...Both the Nuremberg Code and the Declaration of Helsinki served as models for the current U.S. federal research regulations."  

4.  What information do we have regarding the safety, efficacy, necessity and manufacturing fidelity of the 3 Covid-19 vaccines currently authorized under EUAs and those expected to be authorized? 

·      Safety:  2,216 deaths have been reported to a passive reporting system, VAERS, as of March 22.  CDC says it does not have a method for tracking deaths following vaccination, since most of its safety surveillance relies on vaccines administered within the healthcare system. According to MSN, "The struggle to find a way to complete the key vaccination mortality study highlights a growing frustration among officials working on the pandemic response that the federal government is still falling short in collecting, analyzing, and reporting of COVID-19 data." 

·      Yet CDC has assured the public that not a single death has been shown to be due to a vaccination. According to Elisabeth Rosenthal in the LA Times, "we still don't have a uniform national digital database that can track who is getting the vaccine." The bottom line is that we don't have the safety data we need, after over 100 million doses of unlicensed vaccines have been administered.

·      Meanwhile, the Astra-Zeneca vaccine has been found to cause serious, rare blood clots, especially in the brain, in perhaps one in 25,000 young recipients.

·      Data adequacy:  The Emergency Use Authorizations for the Covid-19 vaccines were issued with only a median of 2 months of data.  Only two months.  While the trials were originally expected to continue for 2 years, when vaccine became publicly available, the vaccine manufacturers offered vaccine to the subjects in their trials who had received placebos. Thus, the anticipated datasets from the clinical trials, in which placebo recipients would be compared to vaccine recipients in terms of long-term side effects and infection rates for 2 years, will be greatly abbreviated.  

·       According to Brownlee and Lenzer, "A decision [was] made back in December by the U.S. Food and Drug Administration (FDA). The agency allowed manufacturers to effectively stop their clinical trials as soon as they were authorized to market their vaccines. While the early results from the clinical trials look incredibly promising, we don’t actually know with any precision just how effective and safe they really are – and we probably never will." 

·      Efficacy:  We still do not know to what extent the vaccines are efficacious and to what extent they prevent transmission, both to current strains of Covid-19 and to newer variants.

·      Necessity:  On November 4, 2020, Stars and Stripes revealed that only one active duty servicemember had died as a result of Covid-19.  So had 8 reservists.  There were 59,000 Covid-19 cases documented in the military at that time.  In general, soldiers are young and healthy and unlikely to suffer severe illness or death.

·      Manufacturing fidelity:  The FDA is not required to inspect manufacturers of EUA products, as it is for licensed products.  Whether Good Manufacturing Practices are met is uncertain.  Emergent BioSolutions, which is the subcontractor for the production of the Johnson and Johnson, Astra-Zeneca and Novavax Covid-19 vaccines for the US market, continues to face delays receiving authorization from FDA for its J and J vaccine. This is the company that produces all US anthrax vaccine.  Furthermore, the DHHS Secretary has the authority to waive Good Manufacturing Practice (GMP) requirements for EUA products, and GMP waivers have been issued for other Covid-19 EUA products.

5.  What has the President said previously about Covid-19 vaccine mandates?

·      President Biden told reporters in December that he would not make Covid-19 vaccines mandatory.

6.  What benefits might be available for anyone who is injured as a result of a Covid-19 vaccination? 

·      Under PREPA, Covid vaccines have been designated as "covered countermeasures" by the DHHS Secretary, granting their manufacturers, distributors, healthcare workers and program planners a virtually complete waiver of liability. The single avenue to obtain benefits is the Countermeasures Injury Compensation Program, an administrative program of the DHHS. While benefits are potentially available only for lost wages and medical care, less than 10% of the injured who have applied to the program since it began 11 years ago have received any funds.  There is no court or special master; there is a one-year statute of limitations; and one must be able to prove that one's injury was caused by the vaccine.  The maximum benefit is about $370,000.  The average benefit paid has been about $200,000.  It is funded by Congressional appropriation.