January 15, 2021

They Come in Threes

Maybe this is an old wife’s tale, but it was certainly true for me this week.  After the last post on the Shamanic Death Rites where I wrote about the requests for the rites for 2 deceased individuals, I got a request from a dear friend to do the same thing for her father who passed a few days ago.  Three is certainly a magic number!  I will be tracking him and sending him to the light if necessary today. 

I would like to give a suggestion here.  If you would like for me to do the Death Rites for you after you pass, assuming that I will outlive you, you will need to put my contact information and request in your will.  As I have no intent on moving again anytime soon, all of that information is current and on my web site, www.quantumstargate.com. 

Remember that where you end up after you leave your body for the last time has nothing to do with your religious beliefs and practices, or even your spiritual ones.  It is strictly a matter of your vibrational level at death.  To be in the best possible state at the end of your life, you should be dropping your baggage on a daily basis, processing and letting go of your issues, and raising your vibration by employing a practice that is suitable for you. 

It also helps to know where you are going after you leave your body.  In other words, you need a map!  I have created this map via a guided journey for Rise Multiversity called “#6 The Journey Through Death and Beyond”.  You can get that workshop here on page 2 of the workshops.

I am looking forward to completing the full Death Rites on these 3 individuals in the coming weeks. 

January 11, 2021

Shamanic Death Rites

This week, I have the privilege of performing the Shamanic Death Rites for 2 deceased people, as requested by their loved ones.  I know that I have written about the Death Rites before, but it has been a while.  Considering the world wide deaths as a result of the COVID 19 pandemic, I thought I’d revisit this topic.

The purpose of the Shamanic Death Rites is to assist the soul to drop any heavy regrets and energy that they retained when they passed over, and then launch them up to the energetic level where they can start to plan their next incarnation.  This greatly shortens the time that they would need to spend between lifetimes purging and dropping that baggage, thus accelerating their evolutionary progress.  It also greatly diminishes the suffering that they endure while purging.  On the other hand, I cannot remove the deceased from the wheel of reincarnation, as that is a matter of their soul’s purpose and spiritual evolution. 

I consider this work to be my greatest joy and service, as I find it immensely satisfying.  I really wish that I had more of an opportunity to do this! Some of the indicators that a soul may need the Death Rites are if they died a sudden or painful death, if morphine was administered before their passing, if they clearly died with a lot of guilt or regret, or if the remaining loved ones talk of them often or are grieving for much longer than would be healthy.  The latter is an indicator that the soul is still hanging close the earthly plane and needs assistance to be able to move on.  In the case of the morphine, I realized early on in my healing practice that those who were given morphine at the end suffered from their vibration being lowered to the extent that it was hard for them to leave their body at the time of death, let alone go any further after that. 

Traditionally, the village shaman would sit with the dying person and energetically clear heavy energy, or houcha, from them before they passed.  Then, at the moment of death, the shaman would travel with the soul of the deceased to make sure they reached their destination.  That way, no soul would get lost, stuck or be earthbound.  In other words, become a ghost.  A lovely system, but not perfect.  If a person should accidentally get killed while away from their village, their soul might not be able to find the light on their own.  I have found a number of past lives of clients during healing sessions where they were still wandering the area where they died. 

I have not had the privilege of tending to a person who was in the process of dying, but have done the Shamanic Death Rites on many people after their passing.  This process can be done at any time after death, and even years later.  If you have a deceased loved one that you feel may need assistance to get unstuck and move on, feel free to get in touch with me to discuss the matter.  My first step is to track where they ended up, and send the soul to the light if they are earthbound.  There is no charge for that service, as it takes only a few minutes.  Then you can decide if you want to go further with the Shamanic Death Rites.  You can contact me through my web site at  www.quantumstargate.com

January 4, 2021

One Last Bit

So this is my last post, for now, on the COVID vaccine agenda.  If something else comes up, I will certainly post on that.  Feel free to forward these posts to everyone that you know who might not be well informed about this.  Not having enough information to make a choice to vaccinate or not is a major problem.  We are not sheeple, and should not be expected to just follow the party line.  

Here is a link that was sent to Misha Hendrickson.  It is a post written by David Bryan that features another twist to the agenda.  http://www.321gold.com/editorials/guest/bryan123120.html
 

January 3, 2021

Part 2

 

Here is the continuation of yesterday's post from Mike (Misha) Hendrickson.  If you would like to contact him with questions, his e-mail address is mikenlori9@gmail.com.  

COVID Vaccines Research –paper #2

(Note that a great deal of time has been invested in researching this paper – time sorting through government documents and trying to find real information in public sources. It is now late December 2020 and both the Pfizer and Moderna vaccines have been recommended for emergency use.)

The initial research you received was concluded with a chart reflecting that people were testing positive for flu at the height of this flu season at less than 1% of the rate of last year as reported by public health labs and at 10% of the prior year as reported by clinical labs. Yet, we have not heard from CDC or FDA that the flu was even on the decrease. It is obvious that they have simply shifted the flu numbers over to COVID, which would explain the most significant part of the spike in COVID. Note that there is always a spike in flu in the fall (i.e., flu season) when the trees go dormant and we have a greater ratio of carbon dioxide to oxygen in the air.

(The chart was not included in the previous post)

Lest I sound negative about vaccines, let me be clear. I am sure that the Pfizer and Moderna vaccines work to reduce the incidence of the virus. However, I am deeply concerned, especially about the long-term effects of the vaccines. In particular, I am concerned about the mRNA technology in the vaccines, which has never been introduced into any vaccine before and had an incredibly short test period before being released to be tested via vaccination on the world population.

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There is a lot in this document so here is a Summary of Conclusions of research #2 (the numbers below correspond to explanatory paragraph numbers that follow):

By now we have all heard of an Emergency Use Authorization (“EUA”). It was made into law (2013) so they could have a way to get a vaccine to the public without rigorous testing for efficacy (and also, as it turns out, for safety). In mid-March of this year, having their sights set on producing a vaccine for COVID, without public notice or governmental hearings and acting on the authority of the EUA, they simply issued a blanket order relieving the pharmaceutical companies of liability if anything goes wrong.

For an EUA to be issued, there cannot be a viable treatment option. However, there appear to be viable options that are being silenced.

One of the early actions taken by the FDA was to eliminate liability for the safety and efficacy of any vaccine that was developed. The CDC, FDA and pharmaceutical companies are accorded immunity from prosecution while they operate under the EUA.

We should all be concerned that molecular biologists are experimenting with our DNA, since by their own admission they know very little about our DNA having declared the vast majority of DNA to be “junk”. What if it isn’t junk and actually has an, as yet unknown, purpose?

There is a growing list of doctors and scientists who have objected to the “rush to vaccinate” and who have said the approach to the “pandemic” is completely counter to sound health.

Organizations such as Children’s Health Defense (Robert F Kennedy, Jr.) have a growing mountain of evidence that this is more about a “race to get rich” than a race to secure health. Serious reactions to the dangerous PEG additive (defined in 6 below) and the experimental nature of mRNA are clearly present and are ignored by the FDA, CDC and mainstream news.[1]

Forced vaccinations are upon us and force is being used to eliminate “informed consent” both individually and parentally.

It is not surprising that in this “warp speed” to a vaccine, that there are several things we don’t know and which are particularly troublesome about the vaccines.

We are all watching small businesses struggle and go under. Several shops on El Paseo in Palm Desert have closed and restaurants are limping along with only take-out orders which have put wait staff out of work. Governors are willing to go along even at the risk of bankrupting their states. California uses the threat of removal of liquor licenses to make restaurants obey. This is a mess and all of the focus is on what many doctors have argued is simply a bad flu season. [No further references below for this.]

1. Emergency Use Authorization (“EUA”)– allowed only if no viable option

Neither the Pfizer nor Moderna vaccines have yet been licensed[2]but rather are being manufactured and distributed under an Emergency Use Authorization (“EUA”). An EUA can only be issued if there are no viable options (actual wording from FDA guidance document states: For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition).

See footnote 2 above: Licensure, the first of three processes, involves gaining approval from the Food and Drug Administration (FDA). As a result, it is the longest of these processes. It [approval] can take years, even decades, before pharmaceutical companies can actually start providing the vaccine. For example, the varicella vaccine [chickenpox, a simple childhood illness, which most of us in my generation had as a kid] took nearly 11 years to be licensed by the FDA.

This gets more interesting when you consider that the products that Pharmaceutical companies can distribute under an EUA only need to pass the standard of “May Be Effective”. You might recall from the first research paper that Pfizer used that sort of language in its proposal to the FDA where they said “it is reasonable to believe that…the vaccine… “may be effective”. They didn’t have to say that the vaccine had been demonstrated to be effective – or even demonstrated to be safe for that matter!

In the words of the FDA as set forth in their December 18, 2020 press release “…although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research.

2. Were there viable options? Yes!

Is hydroxychloroquine a viable option? Early on we heard from numerous doctors from LA to NYC that they were using hydroxychloroquine with tremendous success. The drug is over 60 years old so its patents have long ago expired, which means that it is a very inexpensive option.  What was FDA’s response? On June 15, 2020 they withdrew their approval of the drug for emergency use of malaria, said it had serious side effects, and noted it was “unlikely “to be effective in treating COVID-19. [Reported by Lev Facher at Stat+.] There you go, viable option #1 eliminated with a stroke of the pen! So, if you were a doctor, would you publicly recommend it, or even prescribe it for your patients, after FDA’s action to discredit it?

Ivermectin is a drug developed in Japan that has proven safe and has been used since 1987.Ivermectin was recently researched for covidvirus treatment at the University of Wisconsin by Dr Pierre Kory as well as being researched elsewhere. Here is one research study that shows incredibly successful results:Ivermectin ScienceDirect I have not seen FDA comments on Ivermectin so I assume they are giving it the silent treatment since there are numerous studies demonstrating its effectiveness in treating the covidvirus.

Also, Dr Pierre Kory gave passionate testimony to the Senate’s Homeland Security Committee on December 8, 2020 about Ivermectin. It is clear from his testimony and the extensive testing undertaken (over 30 studies) related to its use against the covidvirus that Ivermectin is clearly a valid treatment option. Not surprisingly, the patents for Ivermectin have expired so you can buy it online for a few cents per pill (doctor prescription is of course required). Dr Pierre Kory testimony [The link has had nearly 6 million hits!]

I stopped looking for options after these two because it is clear from the FDA’s action with hydroxychloroquine and silence with respect to Ivermectin that they are not interested in existing inexpensive drugs. If I was concerned about getting the virus, I would declare symptoms and ask a medical provider to prescribe Ivermectin.

3. Shortly after the virus was discovered in the US, action was taken to grant immunity to those who manufacture, distribute and administer the “experimental” vaccinations

See Federal Register of March 17, 2020: “The Secretary is issuing this Declaration pursuant to section 319-F of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.”

From lockdown to a police state is not that great of a distance as noted by a friend in Hungary upon return from the USA: “I had to be quarantined for 10 days once I arrived from the US and the police came to check on me daily if I was actually at home - it was an interesting experience to say the least. There's also a curfew from 8 pm till 5 am each day.”[Quoted with permission]

The International Consortium of Independent Journalists (“ICIJ”), the organization that broke the Panama Papers, the Paradise Papers and Isabel dos Santos’s theft of billions from Angola, has recently reported on kickbacks in medicine. Salix drug maker pleads guilty to FRAUD  Robert F Kennedy, Jr has pointed out that this problem goes deeply into the CDC as well with the payments of large commissions to scientists developing vaccines. Doctors we know are edgy about how blatant pharmaceutical companies are about offering trips and other perks to doctors. Note that professional ethics are compromised when an agency and its scientists receive financial incentives for developing drugs or vaccines while at the same time having responsibility for the safety of the drugs and vaccines and for the protection of the public. Likewise, professional ethics are compromised when doctors receive financial incentives to recommend particular drugs to their patients.

4. The messenger RNA (mRNA) is an experimental application

One of the concerns about science is its willingness to test “in the interest of science”. When science is unbridled, a lot can go wrong. One of the reasons for the Nuremberg trials was the willingness of German scientists to experiment with human beings. That process was banned by international law following the Nuremberg trials, yet here we are with two vaccines, neither of which were tested on animals, an essential step in the development of vaccines.

Is the willingness to experiment on stage here? Are they conducting a DNA experiment, with the entire world population by skipping animal testing? We should all be asking a lot of questions right now about the limits of testing “in the interest of science”.

Molecular biology says that over 90% of our DNA is junk. Intuitively, that feels false to me. In an intuition-based ethics class that I taught for seven years at the University of North Dakota, I asked students questions which, after some training, were answered intuitively. One of the questions was this very question about DNA; did they feel that the vast majority of their DNA was junk? No student ever answered yes!

The molecular biologists at pharmaceutical companies are from the same group of molecular biologists who have declared that most of our DNA is junk. They claim they have developed effective vaccines. However, they are using mRNA for the first time ever), using a technology never before tested in humans. They have somehow decided it is okay to play with our DNA and yet they don’t know the purpose of most of our DNA. Does that feel right to you? Do you think they might be more concerned with science than safety?

5. One of the rules is that individual doctors are not allowed to speak out against big pharmaceutical companies or the medical hierarchy

Following the FDA response in June (2 above), doctors mounted the steps of the Supreme Court in July as reported by Memphis News Channel 3. “The video, which was [viewed] by President Donald Trump before being removed [by Facebook, Twitter, Google and YouTube], featured members of the group, America’s Frontline Doctors, standing on the steps of the Supreme Court claiming that masks aren’t necessary to prevent the spread of coronavirus and promoting hydroxychloroquine as a cure. “We have just met with Vice President Mike Pence to request the administration’s assistance in empowering doctors to prescribe hydroxychloroquine without political obstruction,” Simone Gold, the group’s leader, tweeted. “We also discussed the recent censorship of doctors on social media platforms.”

In addition to the doctors who stood on the steps of the Supreme Court to object to the pandemic, the list of doctors objecting includes a panel of European doctors who have called the lockdowns “criminal to the elderly”; also doctors such as Dr Zach Bush, Dr Sheri Tenpenny, Dr Rachid Buttar, Dr Andrew Gentempo, Dr Andrew Wakefield, Doctor and scientist James Chestnut, Dr Kelly Brogan, doctor and author, Judi Mikovits; and non-doctors such as Brian Hooker, William Thompson and Robert F Kennedy, Jr.

Nearly every one of those named above have been censored by Facebook, Google, Twitter and YouTube. How is that possible in a democracy where freedom of speech should be fundamental so we can have honest discussions and debates on issues affecting all of us?

6. Serious Reactions from potentially dangerous additives

In the “warp speed” drive for a vaccine and the drive to vaccinate the planet, there is a tendency to overlook the dangers. So, let’s be clear – vaccines pose a risk and the risk is real. For example, Children’s Health Defense reports cases of anaphylactic shock acknowledged by the FDA. They also reference an Illinois hospital shutting down its vaccination program because of serious reactions of healthcare workers. Also, there are PEG reactions (PEG is a petroleum-based additive), FDA Warning.21 Dec 2020

Robert F. Kennedy, Jr., CHD chairman and chief legal counsel, said: “As we told the FDA in September, studies show that one in seven Americans may unknowingly be at risk of experiencing an allergic reaction to PEG.”Kennedy noted in the letter that the PEG additive is dangerous and warned that it was known to cause “life-threatening anaphylaxis”. They told him to take his concern directly to the vaccine manufactures!

In addition, Moderna has acknowledged the potential for its proprietary lipid nanoparticles (LNP), PEG or mRNA to produce “systemic side effects. …” Moderna states:“[T]here can be no assurance that our LNPs will not have undesired effects. Our LNPs could contribute, in whole or in part, to one or more of the following: immune reactions, infusion reactions, complement reactions, opsonation[opsonization] reactions, antibody reactions . . . or reactions to the PEG from some lipids or PEG otherwise associated with the LNP. Certain aspects of our investigational medicines may induce immune reactions from either the mRNA or the lipid as well as adverse reactions within liver pathways or degradation of the mRNA or the LNP, any of which could lead to significant adverse events…”

7. Forced Vaccinations

On August 24, 2020, the FDA made it clear that they were going to proceed to forced vaccinations and end any hope of having an “informed consent” process with the experimental vaccines. As always, no hearing, no public debate, just an edict from an institutional hierarchy.Third Amendment to EUA Expect them to target schools and to institute travel restrictions soon.

How serious is this virus? Of course, it is serious, yet a total of 1.4 million people worldwide died from TB in 2019. We know that covid deaths are being inflated and even at that covid deaths worldwide at 1.8 million are not significantly higher than TB deaths. They could just as easily have called TB a pandemic (the vaccine patents have expired so doses are quite cheap).

8. Safety and things we do not know

One simple thing that we do not know is the real source of the SARS CO V-2 virus. The USA says it came from a market in Wuhan but the Chinese have conducted a study of the market and determined that the claim is false. The study has been published in a peer-reviewed medical journal. Although US studies argue that the virus is natural, an international study is adamant that the virus is synthetic Int'l Journal of Medicine Abstract

STAT reported on December 19, 2020 the following in a pro-vaccine, side-by-side comparison of Pfizer and Moderna:

Not known if vaccinated people can transmit the virus. [Really, then what is the point of requiring everyone to be vaccinated?]

Moderna’s dosage is more than three times that of Pfizer with no better result than the Pfizer vaccine. [Yet, at least so far, you will not have a choice of which vaccine you receive, even if you are forced into being vaccinated. Also, why didn’t the FDA question Moderna’s use of a three-times higher dosage, which in its trials was not as effective Pfizer’s?]

It is not known whether either vaccine prevents asymptomatic infection.

Both vaccines fall into the reactogenic category of vaccines, meaning they are expected to produce adverse events. The advisory committee (US) has advised hospitals to stagger vaccinations and in Britain those administering vaccinations have been advised to have standby emergency treatment for possible adverse events.

There has been no determination of how long the vaccination will last, which begs the question of why two doses are required, except for tracking purposes.

Part of the stated reason given for tracking is so they can determine how many vaccinated people are getting the virus and give booster shots. [But apparently not so they could declare the vaccines ineffective.]

According to an FDA press release on December 18, 2020, “The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting, and fever.”[Interestingly, there is no mention of Bells Palsy, which has occurred; likewise, no mention of anaphylactic shock, an allergic reaction to the antigen, which has also occurred and which can be fatal. According to the Mayo Clinic anaphylaxis is a severe, potentially life-threaten allergic reactions.]

On one hand, we are asked to believe that it was necessary to grant immunity to vaccine manufacturers and others involved in the administering of the vaccines, while on the other hand we are told to accept that the forced vaccinations are rational. There is a poster going about that says we have a vaccine so safe that one needs to be forced to take it for a virus so dangerous that you need to be tested to know you have it.

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I will just close this with a personal observation which is that I know far more people who have tested positive with no symptoms than I do people who have been tested positive and who have been sick. Also, we know of people in both California and North Dakota who went to get tested but it was taking too long so they left. In both cases they were sent notices that they tested positive. Apparently, you don’t have to be tested to add to the statistics telling us that the problem is growing!  Also, all of the people who have died that I have heard about from those I know have all had co-morbidities. This includes a report from a doctor in the family who has had six patients die who were called covidvirus deaths; all had co-morbidities and five of them were over age 90!

Finally, if they really wanted people to be healthy, they would do everything in their power to reduce fear. They are not; instead, they are fueling the fear and ignoring the tremendous negative health effects of fear. Consequently, numerous doctors are crying “foul” and speaking out.



[1] Example of factual news about early issues with the vaccines: Severe reactions Pfizer Vaccine

[2]From Children’s Hospital of Philadelphia – how a vaccine gets licensed Vaccine licensing

January 2, 2021

Important COVID Vaccine Information

 

In the last few weeks, I received 2 e-mails from my dear friend Mike Hendrickson, who has spent numerous hours researching the issues with the COVID vaccine.  In this post is the link from his first e-mail detailing what he has found.  It is lengthy and quite detailed and scientific, so I encourage you to take the time to read the whole thing.  I will post his second link in the next blog. 

For myself, I do not plan on taking the vaccine, as there are too many inconsistencies there, and I value the good health that I currently enjoy and choose not to be a part of this global medical experiment.  In addition to Mike’s research, there is plenty of information out there on alternative media to suggest nefarious agendas at play.  Certainly “follow the money” might be one of them!

I would have rather seen our billions of tax payer money go to teaching people how to boost their immune systems, and creating effective treatments once one gets sick.  Hydroxychloroquine, vitamin D3, zinc and IV vitamin C come to mind, in addition to plenty of sunshine and moderate exercise outside every day.  Of course, the pharmaceutical companies can’t make a big profit on those.  

Keep in mind that I am not giving out any medical recommendations or diagnoses here.  These are just my personal opinions, and it is entirely up to you to decide how you would like to proceed.  

I have been going round and round trying to figure out how to put a link to his articles here.  Instead, here is the whole first article. 

You can contact Mike, who goes by Misha these days, at mikenlori9@gmail.com

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mRNA RESEARCH EXCERPTS (bold has been added for emphasis)     [Indicates author comments or explanations added]

Distribution with permission only, please!

Pfizer-BioNTech FDA Briefing Document, December 10, 2020

Here is the document submitted to FDA:  https://www.fda.gov/media/144245/download

The executive summary of the FDA proposal states on page 10: “…it is reasonable to believe that the Pfizer-BionTech COVID-19 vaccine may be effective in preventing COVID-19 in individuals 16 years of age and older…”

 PHG (health policy think tank), University of Cambridge, England

What are RNA vaccines and how do they work?

Conventional vaccines usually contain inactivated disease-causing organisms or proteins made by the pathogen (antigens), which work by mimicking the infectious agent. They stimulate the body’s immune response, so it is primed to respond more rapidly and effectively if exposed to the infectious agent in the future.

RNA vaccines use a different approach that takes advantage of the process that cells use to make proteins: cells use DNA as the template to make messenger RNA (mRNA) molecules, which are then translated to build proteins. An RNA vaccine consists of an mRNA strand that codes for a disease-specific antigen. Once the mRNA strand in the vaccine is inside the body’s cells, the cells use the genetic information to produce the antigen. This antigen is then displayed on the cell surface, where it is recognised by the immune system. [That this technology would be tested on humans in only a short-term test period before mass inoculation is distressing (to me).]

Journal of American Medical Association, September 3, 2020

Despite the unprecedented speed, mRNA vaccines are clinically unproven. No commercially available vaccines use the platform and, until now, it hasn’t been tested in large-scale human trials. With COVID-19, that’s all set to change. Experts said in interviews that if the technology pans out, the pandemic could help to usher in a new plug-and-play approach to vaccinology.

Preexisting immunity could explain why a non–replicating viral vector COVID-19 candidate from CanSino Biologics Inc and several Chinese institutions elicited less-than-impressive neutralizing antibody levels in a phase 1 trial. Preexisting neutralizing antibodies to the vector, the human adenovirus 5, known as Ad5, ranges from up to 69% in the US to 80% in Africa. Of additional concern, Offit [University of Pennsylvania vaccinology professor Paul Offit, MD]said in an August livestream, more than a decade ago, men with preexisting Ad5 immunity had an increased risk of acquiring HIV infection after receiving an experimental Ad5-vectored HIV vaccine.[The point is that risk of an AE (Adverse Reaction) is increased if one has a “natural” immunity to a virus.]

The first 4 COVID-19 vaccine developers with published clinical trial data all used either a non–replicating adenovirus or mRNA platform. The US government is betting on some of these new technologies. Under the auspices of its Operation Warp Speed vaccine development initiative, it has already purchased hundreds of millions of doses of ChAdOx1 nCoV-19, mRNA-1273, BNT162b2, and an investigational non–replicating viral vector vaccine in early trials from Johnson & Johnson–owned Janssen Pharmaceutical Companies, as well as other candidates. Doses should be standing by if or when any of these are approved.

Tolerability could be another issue. “People will have to know that they may have some local reactions or feel like they’re a little under the weather for a day or so after the vaccine,” said Edwards [Kathryn Edwards, MD], scientific director of the Vanderbilt Vaccine Research Program, who is among the independent experts monitoring investigational COVID-19 vaccine safety. She and others said that, as with any new pharmaceutical product, phase 3 studies could also reveal more serious safety concerns and unexpected adverse effects could emerge later. [However, safety cannot be assured without a long-term trial because many AEs don’t emerge immediately.]

Speaking at the July 27 media briefing, Collins[National Institutes of Health (NIH) Director Francis Collins, MD, PhD]addressed concerns: “Yes, we’re going fast. But, no, we are not going to compromise safety or efficacy.” Experts say several factors argue for mRNA vaccines’ safety. For one, mRNA can’t cause an infection. It also doesn’t enter the cell’s nucleus, so the chance of its integration into human DNA is believed to be very low. In addition, the body breaks down mRNA and its lipid carrier within a matter of hours, assuaging some concerns about long-term risks. [I would want a lot more than “arguing” for safety. Also, integration into DNA could be a disaster because it would be irreversible and could even then link genetically to future generations of those affected – we need more assurance than “believed to be”.]

Weissman [Drew Weissman, MD, PhD, researches mRNA vaccines at the University of Pennsylvania Perelman School of Medicine] is trying to develop a more potent second-generation mRNA vaccine that protects with a single shot. He’s also set his sights on a universal coronavirus vaccine using the genetic platform. “We’ve had 3 coronavirus epidemics in the past 20 years,” he said. “The next time this happens, we’ll have a vaccine already made, ready to be shipped out and used very quickly to prevent the pandemic from taking over.”[So, in the interest of science, we go at warp speed? what about the safety for the present?]

Before COVID-19, his team was working on mRNA flu vaccines, as well as candidates for genital herpes and HIV. Influenza viruses acquire variations from season to season, making them excellent candidates for a rapid “vaccine on demand” platform. [It seems to be lost on medicine that there are natural ways to protect yourself from flu, such as vitamin C, vitamin D and zinc; as well as essential oils and colloidal silver which are powerful antivirals. Also, see this important antidote, ivermectin, presented on February 8, 2020 by Doctor Pierre Kory, University of Wisconsin, before Senate Committee, “State of the Pandemic and Development of Outpatient Treatments” (short video): https://www.brighteon.com/f81d427b-aa7d-4da6-a94c-64251e3c3f69]

A comment on the article from Giuliano Ramadori, Professor of Medicine | University Clinic, Internal Medicine, Göttingen, Germany [numbers (4) through (7) are his references to his research sources]: The measurement of such antibodies in the actual COVID-19-vaccine-studies should however transmit the hope that the induced antibodies will prevent SARS-CoV-2-infection. This can only be demonstrated by showing real prevention in a large phase III-study. After approval of the vaccine this should be accepted by all components of the society (White, Black, Hispanic, Asian). As it is, however, the participants in ongoing trials are almost exclusively white (4,5), similar to some influenza vaccine trials(6).The trials seem to exclude the majority of those people who are mainly hit by the infection and therefore less willing to accept vaccination (7). [Early small studies may have been mostly white but I don’t believe it is true of the large group studies; however, children were NOT included in the large double-blind studies.]

New England Journal of Medicine, July 14, 2020, article by panel of 12 doctors on the study of the Moderna mRNA-1273 vaccine of healthy student group at Vanderbilt University

[Adverse Event = An unexpected medical problem that happens during treatment with a drug or other therapy. Source: National Cancer Institute]

 

The 45 enrolled participants [15 in each of three dosage groups] received their first vaccination between March 16 and April 14, 2020 (Fig. S1). Three participants did not receive the second vaccination, including one in the 25-μg group [low dose]who had urticaria [skin reaction such as hives] on both legs, with onset 5 days after the first vaccination, and two (one in the 25-μg group and one in the 250-μg group) who missed the second vaccination window owing to isolation for suspected Covid-19 while the test results, ultimately negative, were pending. All continued to attend scheduled trial visits.[Demographics: mostly white participants. Also, note that they elected to exclude the 3 from the second vaccination who had either a reaction or were suspected of having the virus after the first vaccination.]

 No serious adverse events were noted [during the trial], and no prespecified trial halting rules were met. As noted above, one participant in the 25-μg group was withdrawn because of an unsolicited adverse event, transient urticaria, judged to be related to the first vaccination.

 After the first vaccination, solicited systemic adverse events were reported by 5 participants (33%) in the 25-μg group, 10 (67%) in the 100-μg group, and 8 (53%) in the 250-μg group; all were mild or moderate in severity (Figure 1 and Table S2). Solicited systemic adverse events were more common after the second vaccination and occurred in 7 of 13 participants (54%) in the 25-μg group, all 15 in the 100-μg group, and all 14 in the 250-μg group, with 3 of those participants (21%) reporting one or more severe events.[Total of 86% had adverse events after second shot! Some severe!]

 None of the participants had fever after the first vaccination. After the second vaccination, no participants in the 25-μg group, 6 (40%) in the 100-μg group, and 8 (57%) in the 250-μg group reported fever; one of the events (maximum temperature, 39.6°C) in the 250-μg group was graded severe.

 Local adverse events, when present, were nearly all mild or moderate, and pain at the injection site was common. Across both vaccinations, solicited systemic and local adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site.

 The American Association for the Advancement of Science, Derek Lowe,October 21, 2020

 Lowe quotes the FDA in his article as follows: “It is FDA’s expectation that, following submission of an EUA request and issuance of an EUA, a sponsor would continue to collect placebo-controlled data in any ongoing trials for as long as feasible and would also work towards submission of a Biologics License Application (BLA) as soon as possible. FDA’s recommendations regarding the safety and effectiveness data and information outlined below are essential to ensure that clinical development of a COVID-19 vaccine has progressed far enough that issuance of an EUA for the vaccine would not interfere with the ability of an ongoing Phase 3 trial to demonstrate effectiveness of the vaccine. . .”

“As long as feasible” is a well-crafted way of putting it. But we need to ask just how long that might be. You can see from the latter part of the quote that one of the considerations for issuing an EUA at all will be whether it might fatally disrupt the ongoing Phase III, and indeed, the FDA goes on to say that they don’t consider a vaccine EUA itself as grounds for unblinding. This leads us to the various clinical trial designs and interim data analyses, and how they fit in with an EUA request. It’s important to understand what the interim data readouts are designed to be able to say, which (translated into English from statistics) is something like “the distribution of coronavirus cases observed so far is not inconsistent with the vaccine having an eventual efficacy at the end of the trial of at least X per cent, at a certain pre-defined confidence level”. This sounds rather less definitive than what I think the general public might imagine the unblinding of clinical trial data looks like, and I should also add that it can take longer than you’d think (once you have the unblinded data) even to be able to say that much. This is not like rubbing off a lottery scratch ticket, that’s for sure. Rarely does a trial read out in a way that you look at the raw data and say “Holy guacamole, I think that stuff kicked butt”, although it should be said that obvious butt-kickings in the other direction are somewhat more common. [Meaning that adverse reactions are an important issue!]

We may get into a situation where an interim readout of the data show that a vaccine may well be working, but that granting an immediate EUA has a real danger of blowing the statistics for the complete trial. That is truly the worst outcome: ending up with something that might be useful, but being unable (despite all the time and money and effort) to be able to say if it really is. We’ve got to avoid that.

An additional problem is that I strongly suspect that many participants across all the US trials have a good idea of whether they’re in the placebo group or not. [That would mean that the trial has been botched scientifically because the double-blind requirement would not have been met; to have been met, those receiving the placebo cannot know that they are receiving it, otherwise the test for efficacy of the drug is invalid.]

Quoting FDA: “The placebo-controlled Phase III COVID-19 trials already include at least 30,000 participants, and there will be little acceptance of uncertainty about the efficacy of a vaccine to prevent a life-threatening disease.”

American Association for the Advancement of Science, Jon Cohen, October 14, 2020

Success in the push to find a COVID-19 vaccine at record-breaking speed could hand the world a new problem. The first vaccine to cross the finish line might be only marginally effective, yet it could become the enemy of the good—or even the great—candidates in the wings by disrupting ongoing studies.

In all likelihood, the U.S. Food and Drug Administration (FDA) or other regulators will issue the first COVID-19 vaccine approval or emergency use authorization (EUA) for one vaccine while many other candidates have clinical trials still underway or in the planning. [This happened on December 10, 2020.Note that an EUA is not even close to an approval. We will discuss this further in the next research.] At that point, ongoing studies of any vaccine—including that first one—could become unethical because half the participants would get a placebo, at a time a vaccine with established efficacy will be available. “It’s a very vexing issue,” says Christine Grady, who heads the bioethics department at the National Institutes of Health (NIH) Clinical Center, which organized a “grand rounds” webinar on the challenges last week.

Participants in the NIH [National Institute of Health] webinar agreed that the first EUA for a COVID-19 vaccine will change the landscape for that vaccine’s phase III trial and others. Should the blinded trial continue, to make sure that the early benefits pan out over a longer period of time, or should people in the placebo group immediately receive the vaccine? What if stopping the initial trial early reduces its ability to detect rare side effects, assess how long protection lasts, or compare the vaccine’s efficacy in the elderly versus young adults?

NY Times article, Carl Zimmer, November 20, 2020 (updated December 4, 2020)

A 95 percent efficacy is certainly compelling evidence that a vaccine works well. But that number doesn’t tell you what your chances are of becoming sick if you get vaccinated. And on its own, it also doesn’t say how well the vaccine will bring down Covid-19 across the United States.

[He goes on to show the calculation. There were 43,661 in the study and 170 had gotten sick when the study stopped, which is significantly less than 1%.  162 of those who got sick were in the placebo group and 8 in the vaccinated group. They then divide 162 by 170 to get 95% efficacy. Assuming the two groups were divided equally with about 21,830 in each group, the percentage of people who got sick in the placebo group (162 divided by 21,830 is still less than 1%).]

Dr. Sin Hang Lee and Informed Consent Action Network have filed a petition with the FDA to suspend

“BusinessWire” reported on December 7, 2020:A recent review of a COVID-19 PCR test, which was signed by 22 international scientists, emphatically stated:“To determine whether the amplified products are indeed SARS-CoV-2 genes, biomolecular validation of amplified PCR products is essential. For a diagnostic test, this validation is an absolute must.

The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used a presumptive RT-qPCR diagnostic test. This test is acknowledged by the medical science community to generate high rates of false-positive results among qualified trial participants from the placebo group with minor symptoms such as a sore throat or a new cough. This is especially evident when a de facto unblinding among the trial participants has taken place, according to the petition.

From Rapid Microbiology news feed on July 20, 2020: He [Dr. Sin Hang Lee] has reported that the CDC tests generated 30% false-positive and 20% false-negative results at his laboratory. Sin Hang Lee re-tested 20 reference samples provided by the Connecticut State Department of Public Health Microbiology Laboratory Division to arrive at this conclusion, according to the published article.

Concerns and Recommendations of this Researcher

I am sure that this virus is serious, but I am saying that it is a virus and viruses, by definition, mutate as noted above.

Since mRNA technology has never been used in an FDA approved vaccine, long-term study is essential for safety. Otherwise, those who get vaccinated become the long-term study group.

I am also concerned that mainstream news is not emphasizing this fact and that the experimental mRNA vaccine is messaging our DNA/RNA without known results, especially long-term results.

Considering2 and 3 above,a requirement by any organization for its members to get the vaccination is unconscionable (in my opinion).

All participants in the trials have signed an “informed consent” which is understandable. Since there have been no long-term tests, informed consents should be obtained from all who choose to receive the vaccination. The informed consent should warn the patient that the drug company who produced the vaccine is not responsible for any Adverse Events.

Rather than emphasizing informed consent because of the lack of any long-term trial for an mRNA vaccine, the government, schools and medical businesses are pushing for a “required” policy.

Derek Lowe has acknowledged that viruses mutate which is why the flu vaccine is always different. Lowe said in an article on December 10, 2020, “And what’s going on, of course, is that the virus is mutating. It’s what viruses do.”Do we know that we are targeting an actual virus or are we guessing at the future? I do not know! Do they?

Most troubling to me is that there have been significantly fewer cases of flu reported by the CDC. Down 90% for clinical labs and down 99%+ for public health labs Or, is the flubeing reported as COVID?

There are way too many unanswered questions in this rush to a vaccine with the result that safety is being seriously compromised. We will explore this further in the next post.

 Michael D Hendrickson

Distribution with permission only, please!