The world population is: 7,874,965,825 this year. (7.8 Billion)
Researchers claim that 27.1% of the world population is already vaccinated from Covid 19.
If those stats are correct, that means 2.1 billion have already received the Covid 19 shot.
And according to other researchers, they say that the estimate for those that will eventually die from the vax will do so in 3-10 years, due to the immune system fighting itself and causing illnesses. (some say sooner)
If that is true, then within 10 years 2.1 billion people could die from the Covid 19 shots. Which will reduce the world population by around 25%.
This does not take into account the side effects of reduced fertility, and a much reduced birth rate due to the shot causing sterility world wide.
6 Billion People Humans To Be Killed By The Elite – NWO Depopulation Agenda – Holistic Doctors Who Died Mysteriously Exposed The Dangers of Vaccines and Cures For Cancer
Back in 2015 reports of the suspicious deaths of holistic doctors who exposed the many deadly dangers of vaccines and the correlation to austim began. The mysterious deaths of holistic doctors continue, without any mainstream media reporting, as many of the deaths have “plausible deniability”, which is the top facet of all mass media manipulation and deception.
Since 2015, there has been a major campaign to disprove all of these deaths as “conspiracy theories.”
I knew back then that these holistic doctors were killed to silence their voices regarding the dangers of vaccines and the increasing rise of autism. But there may have been another reason. Once the COVID-19 “scamdemic” was launched these doctors would have been screaming at the top of their voices.
Many physicians who survive have screamed about the dangers of the COVID-19 mRNA injections, like Dr. Joseph Mercola and Dr. Sherri Tenpenny. These physicians have a huge following. The doctors who died “mysteriously” were not nearly as well known, but all had influence and would have trumpeted the dangers of the mRNA vaccines creating a large chorus.
Could that be why there was a barrage of mysterious holistic doctor deaths over the course of a few short years? Very possible.
As I have mentioned many times, the world has been engaged in a silent war waged by the global elite fought with quiet weapons since 1954. The COVID-19 scamdemic is the culmination of the elite’s 63 year plan to reduce the world population to 500,000,000.
We are in the ‘end phase’ of their clandestine depopulation agenda that is hidden in plain sight for all to see, read and hear. The elite talk about it and they write about it. These facts cannot be denied.
“43% of the Covid deaths in UK are vaccinated. Often only 1 vaccination. But also double vaccinated. In the elderly, the risk of death is so high that even 95% protection leads to many deaths. That means: in winter, …. a booster vaccination will probably be necessary” https://t.co/9G5wqSVtQc
And over 50% of UK covid deaths in the past week have been people who were double vaccinated. This is not to say the vaccination isn’t extremely effective and the best protection available, but even those who are fully vaccinated should still be cautious. https://t.co/O332uOzlSB
According to latest UK figures for the delta variant, the death rate for unvaccinated is 0.08% whereas those with 2 doses is 0.69%, I.e. 8.45 times more likely to die catching Covid and fully vaccinated. See page 14 for details. https://t.co/2jsCX7ZDUh
A MailOnline headline on 13 June read: “Study shows 29% of the 42 people who have died after catching the new strain had BOTH vaccinations.” In Public Health England’s technical briefing on 25 June, that figure had risen to 43% (50 of 117), with the majority (60%) having received at least one dose.
It could sound worrying that the majority of people dying in England with the now-dominant Delta (B.1.617.2) variant have been vaccinated. Does this mean the vaccines are ineffective? Far from it, it’s what we would expect from an effective but imperfect vaccine, a risk profile that varies hugely by age and the way the vaccines have been rolled out.
If the Covid vaccine was actually safe, deaths wouldn’t occur.
Metro UK reported similar findings that 12 people who died with the Indian Covid variant in the UK were fully vaccinated:
Almost one third of people in the UK who have so far died from the Indian variant had received both their vaccinations.
Just weeks before England aimed to scrap coronavirus regulations for good, the variant – now officially named ‘Delta’ – has caused cases to soar, sparking fears of another wave of the disease.
But infection numbers are not necessarily what will delay ‘Freedom Day’ on June 21, as scientists will analyse the number of people being hospitalised and dying from the virus.
A new report from Public Health England (PHE) shows out of the 42 British people known to have died with the Delta variant, 12 of them (29%) were fully vaccinated with two doses.
In notes seen by the Sunday Telegraph, PHE epidemiologist Meaghan Kall recorded this ‘percentage of severe outcomes among people [with vaccine] breakthrough infections’ on Friday.
She observed: ‘Who are they and why is that happening? Work ongoing to understand the profile of fully vaxxed people with severe outcomes.’
But it is likely the vaccinated people who died were elderly or sick with pre-existing conditions, and their immunity had dwindled since getting their jabs.
The push to get the Covid jab supersedes rational thinking, it seems.
Unfortunately, but not surprisingly, the US is reporting similar findings amongst the vaccinated dying from Covid.
CNBC recently reported that 4,115 people have been hospitalized or died with Covid-19 despite being fully vaccinated:
More than 4,100 people have been hospitalized or died with Covid-19 in the U.S. even though they’ve been fully vaccinated, according to new data from the Centers for Disease Control and Prevention.
So far, at least 750 fully vaccinated people have died after contracting Covid, but the CDC noted that 142 of those fatalities were asymptomatic or unrelated to Covid-19, according to data as of Monday that was released Friday.
The CDC received 3,907 reports of people who have been hospitalized with breakthrough Covid infections, despite being fully vaccinated. Of those, more than 1,000 of those patients were asymptomatic or their hospitalizations weren’t related to Covid-19, the CDC said.
“To be expected,” Dr. Paul Offit, a top advisor to the Food and Drug Administration on children’s vaccines told CNBC. “The vaccines aren’t 100% effective, even against severe disease. Very small percentage of the 600,000 deaths.”
Breakthrough cases are Covid-19 infections that bypass vaccine protection. They are very rare and many are asymptomatic. The vaccines are highly effective but don’t block every infection. Pfizer and Moderna’s phase three clinical studies found that their two-dose regimens were 95% and 94% effective at blocking Covid-19, respectively, while Johnson & Johnson’s one-shot vaccine was found to be 66% effective in its studies. All three, however, have been found to be extremely effective in preventing people from getting severely sick from Covid.
The CDC doesn’t count every breakthrough case. It stopped counting all breakthrough cases May 1 and now only tallies those that lead to hospitalization or death, a move the agency was criticized for by health experts.
Most Americans have received at least one shot of the two currently authorized mRNA vaccines. The U.S. has administered 178.3 million shots and fully vaccinated 46% of its population.
“You are just as likely to be killed by a meteorite as die from Covid after a vaccine,” Dr. Peter Chin-Hong, an infectious disease expert at the University of California San Francisco, told CNBC. “In the big scheme of things, the vaccines are tremendously powerful.”
Efficacy rates decrease slightly for variants like alpha and delta, with studies indicating 88% efficacy against the delta strain after two doses of the Pfizer vaccine. It was unclear if any of the reported breakthrough cases were caused by variants.
In Israel and the United Kingdom, concerns about the delta variant are rising after growing reports of breakthrough infections.
Even with 80% of adults vaccinated, Chezy Levy, director-general of Israel’s Health Ministry, said the delta variant is responsible for 70% of new infections in the country. Levy also said that one-third of those new infections were in vaccinated individuals.
In the U.K., Public Health England released a report that found 26 out of 73 deaths caused by the delta variant occurred in fully vaccinated people from June 8 to June 14. Most of the deaths occurred in unvaccinated individuals.
“Determination of whether hospitalizations and deaths are more represented in immunocompromised patients and the type of vaccine received will be important for future guidance,” Chin-Hong said.
On June 7, the CDC received reports of 3,459 breakthrough cases that led to hospitalization or death. On June 18, that number was updated to 3,729, an increase of 270 cases. Today, the number stands at 4,115.
An overwhelming majority, 76%, of the hospitalizations and deaths from breakthrough cases occurred in people over the age of 65.
″We do not have the years and years of data we have for vaccines against other airborne pathogens — and therefore it is really essential that the CDC provides up to date reporting on breakthrough cases,” David Edwards, aerosol scientist and Harvard University professor, told CNBC.
The CDC says its numbers are “likely an undercount” of all Covid infections in vaccinated people because the data relies on passive and voluntary reporting.
Interestingly, the CDC says the number of breakthrough Covid cases that lead to death is likely an undercount!
How many more people have to die before they shut down the human experiments?
If a few Covid deaths can lockdown the country, surely a few Covid vaccine deaths should shut down the program.
If ONE DEATH out of 10,000 COVID cases shut down the country, shouldn’t ONE DEATH out of 10,000 vaccines shut down the program?
–Dr. Robert Malone, inventor of mRNA technology that’s used in the COVID vaccine, said young adults and teens shouldn’t be forced to get the vaccine –He told Fox’s Tucker Carlson that there isn’t enough risk-benefit analysis data for that age group –Earlier today, a CDC advisory group said there is a ‘likely link’ between rare cases of heart inflammation in that age group and the COVID-19 vaccine
The inventor of mRNA vaccines said ‘the government is not being transparent about the risks‘ of the COVID-19 vaccine after YouTube deleted a video where he discussed potential risks for young adults and teens.
Dr. Robert Malone, who invented the mRNA technology that’s now being used in the COVID-19 vaccine, told Fox’s Tucker Carlson on Wednesday night that there isn’t enough data about the risks for these age groups and doesn’t believe they should be forced to get vaccinated.
‘I don’t think the benefits outweigh the risks in that cohort,’ said Malone, referring to people in the 18 to 22 age bracket, ‘but unfortunately the risk-benefit analysis is not being done.’
‘My concern is I know there are risks but we don’t have access to the data,’ Malone said. ‘And so, I am of the opinion that people have the right to decide whether to accept vaccines or not, especially since these are experimental vaccines.’
Malone shared his concerns the same day that an advisory group for the Centers for Disease Control and Prevention say there is a ‘likely link’ between rare cases of heart inflammation in adolescents and young adults and the Pfizer/BioNTech and Moderna COVID-19 vaccines.
They also discuss the lack of proper animal studies for the new mRNA vaccines, and the theory, espoused by virologist Geert Vanden Bossche, Ph.D., that mass vaccination with the mRNA vaccines could produce ever more transmissible and potentially deadly variants.
As The Defender reported June 3, Bridle received a copy of a Japanese biodistribution study — which had been kept from the public — as a result of a freedom of information request made to the Japanese government for Pfizer data.
Prior to the study’s disclosure, the public was led to believe by regulators and vaccine developers that the spike protein produced by mRNA COVID vaccines stayed in the shoulder where it was injected and was not biologically active — even though regulators around the world had a copy of the study which showed otherwise.
The biodistribution study obtained by Bridle showed lipid nanoparticles from the vaccine did not stay in the deltoid muscle where they were injected as the vaccine’s developers claimed would happen, but circulated throughout the body and accumulated in large concentrations in organs and tissues, including the spleen, bone marrow, liver, adrenal glands and — in “quite high concentrations” — in the ovaries.
The mRNA — or messenger RNA — is what tells the body to manufacture the spike protein. The lipid nanoparticles are like the “boxes” the mRNA is shipped in, according to Malone. “If you find lipid nanoparticles in an organ or tissue, that tells you the drug got to that location,” Malone explained.
According to the data in the Japanese study, lipid nanoparticles were found in the whole blood circulating throughout the body within four hours, and then settled in large concentrations in the ovaries, bone marrow and lymph nodes.
Malone said there needed to be monitoring of vaccine recipients for leukemia and lymphomas as there were concentrations of lipid nanoparticles in the bone marrow and lymph nodes. But those signals often don’t show up for six months to three or nine years down the road, he said.
Usually, signals like this are picked up in animal studies and long-term clinical trials, but this didn’t happen with mRNA vaccines, Malone said.
Malone said there are two adverse event signals that are becoming apparent to the U.S. Food and Drug Administration (FDA). One of them is thrombocytopenia — not having enough platelets, which are manufactured in the bone marrow. The other is reactivation of latent viruses.
Malone found the ovarian signal perplexing because there is no accumulation in the testes.
Malone said the original data packages contained this biodistribution information. “This data has been out there a long time” within the protected, non-disclosed, purview of the regulators across the world, he said.
According to Malone, the FDA knew the COVID spike protein was biologically active and could travel from the injection site and cause adverse events, and that the spike protein, if biologically active, is very dangerous.
In fact, Malone was one of many scientists to warn the FDA about the dangers of the free spike protein.
Malone also made this comment on Twitter referencing the effectiveness of Ivermectin:
What happens to confidence in public health and USG if ivermectin turns out to be safe and effective for COVID, and the genetic vaccines turn out to have signficant safety issues? This looks like a very plausible scenario from where I sit.
The first-ever autopsy of a person vaccinated against COVID-19, who tested negative 18 days later upon hospital admission but at 24 days after the VAX, has revealed viral RNA was found in almost every organ of the body. The vaccine, while triggering an immune response, DID NOT STOP the virus from entering every organ in the body.
The viral RNA was found in virtually every organ in the body, which means the spike proteins as well.
There are antibodies (like the “vaccine” is supposed to create) but they’re irrelevant because, based on a study from Japan, we now know that the spike S1 protein is what does the damage.
We spoke to one Infectious Disease specialist from a hospital in New Jersey this morning. We sent the actual autopsy findings to him and asked for his thoughts.
When he called back a while later, he was clearly shaken-up. He told us “You cannot quote me by name, I will get fired by the hospital if you do.” We agreed to conceal his identity.
He then told us:
“People think that only a MINORITY of people get adverse effects from the vaccine.
Based on this new research, it means that everyone – EVENTUALLY -will have adverse effects, because those spike proteins will be binding to ACE2 receptors everywhere in the body.
That mRNA was supposed to stay in the injection site and it’s not. That means the spike proteins created by the mRNA will be in every organ as well, and we now know it is the spike proteins that do the damage.
Worse, the viral RNA being found in every organ despite a vaccine, indicates either:
1) The vaccine doesn’t work at all, OR;
2) The virus is enjoying Antibody Dependent Enhancement (ADE), meaning it actually spreads FASTER in vaccinated people.
This is a GLOBAL TIMEBOMB.”
According to the published postmortem report, the vaccinated man was 86 years old and tested NEGATIVE for COVID-19 when first admitted to the hospital with severe gastro-intestinal trouble and difficulty breathing. Here is what the reports describes:
We report on an 86-year-old male resident of a retirement home who received vaccine against SARS-CoV-2. Past medical history included systemic arterial hypertension, chronic venous insufficiency, dementia and prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-formulated, nucleoside-modified RNA vaccine BNT162b2 in a 30 μg dose. On that day and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On day 18, he was admitted to hospital for worsening diarrhea. Since he did not present with any clinical signs of COVID-19, isolation in a specific setting did not occur. Laboratory testing revealed hypochromic anemia and increased creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for SARS-CoV-2 were negative.
The report of the postmortem makes clear tests showed “no morphological changes associated with COVID” in his organs.
“Morphological” means structural. COVID infection is now known to cause very specific structural changes to the places it infects. THOSE CHANGES HAD NOT APPEARED in the vaccinated man before he died.
The now dead vaccinated man was in a room where another patient ultimately tested POSTIVE for COVID, and the report states they think the dead vaccinated man caught COVID after he was admitted, from the other patient in the same room.
So the damage to the organs of the now dead vaccine recipient, took place BEFORE he was infected with COVID by the other hospital room patient.
Worse, once the vaccinated man actually got COVID, it spread so fast within his body, he apparently never stood a chance. Here are tissue images:
The full postmortem report is published at ScienceDirect.com (HERE)
HAL TURNER COMMENTARY
I am not a Doctor or a Scientist so I cannot offer a competent medical analysis, but as a layman, from where I sit, this doesn’t look so good.
The Postmortem report says clearly “ These results indicate that the patient had already developed relevant immunogenicity through vaccination” yet he got infected by another patient at day 24 (after vax) upon being admitted to the hospital, and died 4 days later.
If one reads the entire article, the whole story is: Patient was given the vaccine, it got him hospitalized with ulcerative colitis due to blood clots, during his hospitalization he got infected by an asymptomatic hospital room mate, and died 4 days later.
My conclusion: the jab drove this elderly man to his end.
I might be wrong, but this is what I see from the postmortem report.
I have **not** taken the vax and I do not intend to take it.
Throughout this entire COVID debacle, the one constant is that the disease has a 99.8% SURVIVAL rate. To me, it’s not a pandemic. To me it’s not even worth getting a vaccine; I think my immune system will handle it just fine.
Given all the adverse reactions to the vax, I now firmly conclude that getting the vax is a far more dangerous thing than getting the actual illness.
God gave me an immune system. I think I will trust God on this. After all, I truly believe I will not live one micro-second longer than God wants, and conversely, I will not die one micro-second sooner than God wants.
Faith is not “belief without proof” it is “trust without reservation.” I trust God.
SUDDEN DEATH of 32 YEAR OLD
This couple’s step-son, age 32, died from a heart attack 12 hours after getting the Johnson & Johnson Vaccine. Coroner refuses to release reports; calls cause of death “inconclusive.” A lot of these deaths are simply being covered up. Here’s the family to tell you:
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Homology between human and viral proteins is an established factor in viral- or vaccine-induced autoimmunity.
Failure of SARS and MERS vaccines in animal trials involved pathogenesis consistent with an immunological priming that could involve autoimmunity in lung tissues due to previous exposure to the SARS and MERS spike protein.
Exposure pathogenesis to SARS-CoV-2 in COVID-19 likely will lead to similar outcomes. Immunogenic peptides in viruses or bacteria that match human proteins are good candidates for pathogenic priming peptides (similar to the more diffuse idea of “immune enhancement”). Here I provide an assessment of potential for human pathogenesis via autoimmunity via exposure, via infection or injection. SAR-CoV-2 spike proteins, and all other SARS-CoV-2 proteins, immunogenic epitopes in each SARS-CoV-2 protein were compared to human proteins in search of high local homologous matching.
Only one immunogenic epitope in a SARS-CoV-2 had no homology to human proteins. If all of the parts of the epitopes that are homologous to human proteins are excluded from consideration due to risk of pathogenic priming, the remaining immunogenic parts of the epitopes may be still immunogenic and remain as potentially viable candidates for vaccine development.
Mapping of the genes encoding human protein matches to pathways point to targets that could explain the observed presentation of symptoms in COVID-19 disease. It also strongly points to a large number of opportunities for expected disturbances in the immune system itself, targeting elements of MHC Class I and Class II antigen presentation, PD-1 signaling, cross-presentation of soluble exogenous antigens and the ER-Phagosome pathway. Translational consequences of these findings are explored.
Reaction of Human Monoclonal Antibodies to SARS-CoV-2 Proteins With Tissue Antigens: Implications for Autoimmune Diseases
1Department of Immunology, Immunosciences Laboratory, Inc., Los Angeles, CA, United States
2Department of Preventive Medicine, Loma Linda University School of Medicine, Loma Linda, CA, United States
3Regenera Medical, Los Angeles, CA, United States
4Department of Neurology, Harvard Medical School, Boston, MA, United States
5Department of Neurology, Massachusetts General Hospital, Charlestown, MA, United States
We sought to determine whether immune reactivity occurs between anti-SARS-CoV-2 protein antibodies and human tissue antigens, and whether molecular mimicry between COVID-19 viral proteins and human tissues could be the cause. We applied both human monoclonal anti-SARS-Cov-2 antibodies (spike protein, nucleoprotein) and rabbit polyclonal anti-SARS-Cov-2 antibodies (envelope protein, membrane protein) to 55 different tissue antigens. We found that SARS-CoV-2 antibodies had reactions with 28 out of 55 tissue antigens, representing a diversity of tissue groups that included barrier proteins, gastrointestinal, thyroid and neural tissues, and more.
We also did selective epitope mapping using BLAST and showed similarities and homology between spike, nucleoprotein, and many other SARS-CoV-2 proteins with the human tissue antigens mitochondria M2, F-actin and TPO. This extensive immune cross-reactivity between SARS-CoV-2 antibodies and different antigen groups may play a role in the multi-system disease process of COVID-19, influence the severity of the disease, precipitate the onset of autoimmunity in susceptible subgroups, and potentially exacerbate autoimmunity in subjects that have pre-existing autoimmune diseases.
Very recently, human monoclonal antibodies were approved for use on patients with COVID-19. The human monoclonal antibodies used in this study are almost identical with these approved antibodies. Thus, our results can establish the potential risk for autoimmunity and multi-system disorders with COVID-19 that may come from cross-reactivity between our own human tissues and this dreaded virus, and thus ensure that the badly-needed vaccines and treatments being developed for it are truly safe to use against this disease.
Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons
Many pregnant persons in the United States are receiving messenger RNA (mRNA) coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy.
From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.
A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases).
Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
Ever since reports have surfaced in recent days that people who have chosen NOT to receive the experimental COVID-19 shots but have been exposed to those who have received them, and have suffered what appear to be infections coming from these fully “vaccinated” people, affecting mainly women who have reported menstruation difficulties, heavy bleeding, miscarriages, and reduction of breast milk, I have been watching my newsfeed to see if any of the dissenting doctors and scientists we feature regularly here at Health Impact News would address these issues.
Fortunately, a team of 5 doctors in the U.S., all of whom we have featured in the past here at Health Impact News and are highly qualified to address this topic, just held a round-table discussion a couple of days ago to address these issues.
The issues they discuss affect ALL of us in the U.S. (and around the world) right now, and it is imperative that you take 79 minutes of your time to watch this video.
Not only do these highly qualified doctors discuss why they think this is happening, they also give practical advice at the end about what we can be doing right now to protect ourselves and stop this attack on the human race by the Globalists seeking to reduce the world’s population.
Every single one of these doctors believe that these shots are NOT vaccines, but bioweapons designed to kill human beings.
Whatever else you are doing when you come across this video, it is highly unlikely that anything else you do the rest of your day will be more important than watching this video so you can be informed of the evil effects of these injections that are being censored in the corporate media and Big Tech social media.
According to the CTIAP, all of the vaccines were put on the market and actively used on human beings before ‘proof of quality for the active substance and the finished product’ was produced.
April 22, 2021 (LifeSiteNews) — A regional independent drug assessment center, the CTIAP (Centre territorial d’Information indépendante et d’Avis pharmaceutiques), which is linked to the Cholet public hospital in the west of France, recently published a report showing that the vaccines used against COVID were not only submitted to insufficient clinical testing, but that the quality of the active substances, their “excipients, some of which are new,” and the manufacturing processes are problematic. “These new excipients should be considered as new active substances,” the Cholet hospital team stated, in a study that according to them raises issues that have not been commented to date.
The team led by Dr. Catherine Frade, a pharmacist, worked on public data released by the EMA with relation to the Pfizer, Moderna, AstraZeneca and Janssen (Johnson & Johnson) shots, and its first caveat was that all these products only have temporary marketing authorizations. They are all subject to further studies that reach as far as 2024 and even beyond, and these will be almost impossible to be completed because of the way the vaccines are now being distributed, said the CTIAP report.
These studies even include the stability and comparability of the vaccine batches put on the market and the quality and safety of excipients — substances formulated alongside the active ingredient of a medication to facilitate or enhance their absorption.
According to the CTIAP, all of the vaccines were put on the market and actively used on human beings before “proof of quality for the active substance and the finished product” was produced: all the manufacturing labs obtained future deadlines to submit their studies in this regard.
The authors of the report consider that the “variabilities, which impact the very core of the product, could even invalidate any clinical trials conducted” in the coming months and years.
They go so far as to state: “Prudence would even dictate that, in all countries where these vaccines against COVID-19 have been marketed, all the batches thus ‘released’ should be withdrawn immediately; and that these MAs that have been granted should be suspended, or even canceled, as a matter of urgency until further notice.”
Can we imagine launching a car manufacturing line and putting vehicles on the road, despite the uncertainties noted in the official documents published? These uncertainties are related to the quality of the parts making up the engine and the various other parts, including those related to safety, the manufacturing process, the reproducibility of the batches that are being marketed, etc.
In the field of medicines (including vaccines), the pharmaceutical act of “release” of the finished product (an authorized product intended for sale) constitutes the final stage of control that precedes the release of these products to the population. This key step of “release” is under the pharmaceutical responsibility of the manufacturers.
Following its previous analyses, the CTIAP of the Cholet Hospital Center has once again revealed to the public, and probably in an unprecedented and exclusive way, new vital information concerning the following four vaccines against COVID-19: the one from the BioNTech/Pfizer laboratory; the one from the Moderna laboratory; the one from the Astra Zeneca laboratory; the one from the Janssen laboratory.
This work was made possible thanks to the valuable contribution of Dr. Catherine Frade, pharmacist and former director of international regulatory affairs in the pharmaceutical industry. She graciously provided us with a documented, written alert. In this document, she sheds light on data extracted, on March 22, 2021, from the MA (marketing authorization) itself; an MA qualified as “conditional.” She has extracted “source data that is difficult to identify by someone who does not work in the field.” This data is therefore public and verifiable. First of all, it should be noted that the author of this document no longer works in the pharmaceutical industry; she states: “First of all, I would like to make it clear that I have no conflict of interest with the pharmaceutical industry.” It is therefore with her agreement that CTIAP intends to make available to the public, health professionals, decision-makers … an analysis of some of these data that all should read carefully.
This reflection first presents what a “conditional” MA is (I). Then, it recalls that the studies for these vaccines are not complete, as they run from “2021 to at least 2024” (II). Then, it reveals, in an unprecedented and exclusive way, that the official documents, published by the European Medicines Agency (EMA), underline the insufficiency of the evidence concerning also the “quality” of the “active substance” and of the “excipients,” of the “manufacturing process,” of the “reproducibility of the batches” that are being commercialized, etc. (III). Finally, this analysis proposes a conclusion.
I — First of all, it is important to understand what a “conditional” MA is
An MA is to a drug what a car registration document is to a car. MA is granted when a drug has proven its quality, efficacy, and safety; with a positive benefit/risk ratio: that is, it presents more benefits than risks. Obtaining this MA is the essential condition for a pharmaceutical laboratory to sell any drug, including vaccines.
Here, in the case of these vaccines against COVID-19, the four MAs issued are so-called “conditional” MAs. They are temporary. They are valid for no more than one year, because they were obtained on the basis of “incomplete data.” To obtain a standard 5-year MA, the laboratories concerned must provide dossiers completed with “studies in progress and studies planned for the coming years.” Throughout “this development,” close and coordinated monitoring between the manufacturing laboratories and the health authorities is organized through regular discussions. The “conditional” MA is “re-evaluated each year” according to the contribution and critical analysis of additional data provided and collected during a full year.
This “conditional” MA is a European MA. It was obtained through the centralized accelerated procedure. It allows simultaneous marketing in the following 30 countries (European Union and European Free Trade Association): Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden.
The studies concerning these four vaccines are therefore still in progress.
II — Secondly, the planned studies are still in progress and are spread over a period ranging from “2021 to at least 2024”
All of the studies submitted during the MA application are summarized in the EPAR (European Public Assessment Report). This report is published on the European Medicines Agency (EMA) website. The planned studies, not yet completed, are also included.
This schedule, which “extends from 2021 to at least 2024,” depending on which COVID-19 vaccine is involved, is defined in the “annexes” of the conditional marketing authorization and in the published EPARs.
As an example, the BioNTech/Pfizer vaccine received this European conditional MA on December 21, 2020. And the deadline for filing “confirmation” of efficacy, safety, and tolerability of this vaccine is “December 2023.”
The Moderna vaccine was granted marketing authorization on January 6, 2021. The deadline for filing “confirmation” of efficacy, safety, and tolerability of the vaccine is “December 2022” at the earliest.
AstraZeneca’s vaccine was granted marketing authorization on January 29, 2021. The deadline for filing “confirmation” of efficacy, safety, and tolerability of the vaccine is “March 2024.”
The Janssen vaccine was granted conditional European marketing authorization on March 11, 2021. The deadline for submitting “confirmation” of the vaccine’s efficacy, safety and tolerance is “December 2023.”
However, to date — and this is undoubtedly where the unprecedented and exclusive revelation of this study lies — another deadline has been set for these four vaccines. This deadline no longer concerns only the ongoing clinical trials, but also the “proof of quality for the active substance and the finished product” itself: that is, the intrinsic quality (the heart) of the product sold and administered to millions of people.
III — Thirdly, and this seems to be unprecedented, the published official documents also underline the incompleteness of the evidence concerning the “quality” of the “active substance” and “excipients,” the “manufacturing process,” the ”reproducibility of the batches” marketed, etc.
The deadline for submitting additional evidence on the “quality” of the “active substance” and the “finished product” (i.e., the vaccine that is authorized and sold) is set for:
“July 2021” for BioNTech/Pfizer;
“June 2021” for Moderna;
“June 2022” for Astra Zeneca;
“August 2021” for Janssen.
Indeed, for these 4 vaccines, paragraph E, “Specific obligation regarding post-authorization measures for the conditional marketing authorization,” taken from Annex II of the MA, clearly states the following:
For the BioNTech/Pfizer vaccine (pages 18-19)
By “March 2021,” the laboratory must provide “additional validation data” to “confirm the reproducibility of the finished product manufacturing process.”
By “July 2021,” the laboratory must provide missing information to:
“complete the characterization of the active substance and the finished product;”
“strengthen the control strategy, including the specifications of the active substance and the finished product” in order to “ensure the constant quality of the product;”
“provide additional information regarding its synthesis process and control strategy” in order to “confirm the purity profile of the excipient ALC-0315” and “to ensure quality control and batch-to-batch reproducibility throughout the life cycle of the finished product;”
and by “December 2023,” and “in order to confirm the efficacy and safety” of this vaccine, the company “shall submit the final clinical study report for the randomized, placebo-controlled, blind observer study (Study C4591001).
For the Moderna vaccine (page 15)
The laboratory should provide the missing information to:
“complete the characterization of the manufacturing processes of the active substance and the finished product” (deadline “January 2021”);
confirm the reproducibility of the manufacturing process of the active substance and the finished product (initial and final batch sizes) (deadline “April 2021”);
“provide additional information on the stability of the active substance and the finished product and review the specifications of the active substance and the finished product after longer industrial practice” with the aim of “ensuring consistent product quality” (deadline “June 2021”);
“submit the final study report for the randomized, placebo-controlled, blinded clinical trial for the mRNA-1273-P301 observer” to “confirm the efficacy and safety of COVID-19 vaccine Moderna” (by December 2022).
For the Astra Zeneca vaccine (pages 14-15)
The laboratory must submit the missing information in order to:
“provide additional validation and comparability data, and initiate further testing” with the aim of “confirming the reproducibility of the manufacturing processes of the active substance and the finished product” (by “December 2021”);
“Provide the main analysis (based on the December 7 data cut-off (post database lock) and the final analysis of the combined pivotal studies” to “confirm the efficacy and safety of COVID-19 Vaccine AstraZeneca” (deadline “March 5, 2021” (for the main analysis) and “May 31, 2022” (for the combined analysis);
“submit final reports of the randomized controlled clinical studies COV001, COV002, COV003 and COV005” to “confirm the efficacy and safety of COVID-19 Vaccine AstraZeneca” (due “May 31, 2022”);
“provide additional data regarding the stability of the active substance and the finished product and revise the specifications of the finished product after extensive industrial practice” in order to “ensure consistent product quality” (deadline “June 2022”);
“submit the synthesis and summaries of the primary analysis and the final clinical study report for study D8110C00001” to “confirm the efficacy and safety of COVID-19 vaccine AstraZeneca in the elderly and in subjects with underlying disease” — due “April 30, 2021” (for the primary analysis) and “March 31, 2024” (for the final study report).
For the Janssen vaccine (page 18)
The laboratory should submit the missing information to:
“provide additional comparability and validation data” to “confirm the reproducibility of the manufacturing process of the finished product” (deadline “August 15, 2021”);
submit the final report of the VAC31518COV3001 randomized, placebo-controlled, single-blind clinical study to “confirm the efficacy and safety of the COVID-19 Ad26.COV2.S vaccine” by December 31, 2023.
These facts allow us to offer a conclusion.
For these reasons, which are not exhaustive, it has proved useful to look for and read the content of the paragraph E: “Specific obligation relating to post-authorization measures concerning the conditional marketing authorization,” extracted from Annex II of the MA, corresponding to each of these 4 vaccines against COVID-19.
The inadequacy of the evaluation does not only concern the clinical trials (studies conducted in humans (women and men)), but also the quality of the active substance, the excipients, some of which are new, the manufacturing process, and the batches released and administered to humans in several countries around the world.
Moreover, these new excipients must be considered as new active ingredients, and thus be the subject of a complete evaluation file similar to that required for a new active ingredient.
Changing the commercial name of one of these vaccines, as was recently announced for the AstraZeneca vaccine in particular, can only be considered as a cosmetic arrangement of the product’s image for marketing purposes (winning new public confidence, boosting sales). It would not answer the questions raised concerning the quality, efficacy and safety of the product. This is one of the usual techniques used to put make-up on (dissimulate) certain undesirable characteristics of the product concerned. It is a technique that has been used to present other drugs in the best possible light.
As already mentioned, in the field of medicines (including vaccines), the “release” of the finished product (intended for sale) is the final stage of control (of quality and therefore of safety) before making these products available to the population.
This key stage of “release” of batches is the pharmaceutical responsibility of the manufacturers. However, the responsibility of the users (institutions and health professionals in particular) may also be involved.
In our opinion, these clinical studies should never have begun before the intrinsic quality of the finished product and its manufacturing process had been fully mastered; before the formulas of these vaccines had been stabilized.
How can the results of these clinical trials, conducted on a global scale, be compared if the vaccine administered can vary from one manufacture to another, from one batch to another, from one region to another?
These variabilities, which impact the very core of the product, could even invalidate any clinical trials conducted.
Even in the case of a health emergency, it is therefore difficult for us to understand the basis for the MA (marketing authorization) that has been granted to these COVID-19 vaccines.
In addition to the uncertainties related to COVID-19, there are also the approximations related to the use, and the intrinsic quality, of these vaccines. Now two problems will have to be managed instead of one.
The maneuver seems subtle. The useful information is available in the official documents published in the framework of the MA; but this data is not made visible by the official discourse. It seems the latter has only tried to present these products as being effective and safe, without reservations; even though the formulas and manufacturing processes of these vaccines do not even seem to have been fully stabilized yet.
These new revelations, which are undoubtedly unprecedented and exclusive, further cast doubt on the validity of consent (a fundamental freedom) that is supposed to be free and informed, and which is said to have been given by the people who are now already vaccinated.
Every person has the right to clear, fair and appropriate information. This information is also perennial: if new data is revealed, those already vaccinated must be informed a posteriori (after the administration of this or that vaccine).
The “obligation” to vaccinate cannot therefore be sustained, even in a disguised form, notably through a “vaccine passport.”
Vulnerability does not only arise from the age and state of health of individuals. Not being able to access independent information on medicines (including vaccines) is the first form of poverty and inequality.
Moreover, concerning the uncertainties on the effectiveness of these vaccines, the Council of State noted, on March 3, 2021, in particular the admission of the Ministry of Solidarity and Health itself, and the contradictions of the French “administration.” In this decision, and against the opinion of this Ministry, the Council of State had produced a decision that seemed to tend towards the recognition of this effectiveness. But, a few days later, in a new decision (n° 450413) issued on March 11, 2021, the Council of State changed its position and admitted “the uncertainty that remains regarding the real effectiveness of the vaccine in terms of the spread of the virus.” It should also be recalled that, on February 18, 2021, the Minister of Solidarity and Health also recognized, and that publicly, that no European country has been able to provide proof that these vaccines can prevent “severe” forms of COVID-19 (see press conference, starting at 34min 44s).
In its latest “Update on the surveillance of COVID-19 vaccines — Period from 12/03/2021 to 18/03/2021” published on March 26, 2021, and updated on March 29, 2021, the French National Agency for the Safety of Medicines (ANSM) reports, in particular, the number of deaths that have occurred in France after the administration of these vaccines. Deaths that are notified (reported) in pharmacovigilance (regardless of the certainty of the “causal link” between these vaccines and these deaths): “311 deaths” after administration of the BioNTech/Pfizer vaccine; “4 deaths” after administration of the Moderna vaccine; “20 deaths” after administration of the Astra Zeneca vaccine; (no data is available at this time regarding the latest vaccine (Janssen) to be licensed). In general, for all drugs, there is a high level of under-reporting in pharmacovigilance despite the mandatory nature of these reports.
Consequently, prudence would even dictate that, in all countries where these vaccines against COVID-19 have been marketed, all the batches thus “released” should be withdrawn immediately; and that these MAs that have been granted should be suspended, or even cancelled, as a matter of urgency until further notice. In any case, this is the sense of the recommendations that we could suggest to the ad hoc authorities, and in particular to the French authorities. And, at the very least, this information must be made known to everyone in a clear, fair, and appropriate manner.
All the more so since, in the case of serious adverse effects, including deaths, and in order to establish the said “causal link” with certainty, the victims and their families are often powerless when faced with the requirement of “probatio diabolica” [a legal requirement to achieve an impossible proof].