Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed

Covid-19 Vaccine Protocols Reveal That Trials Are Designed To Succeed

Not surprising to most who are familiar with the ‘science’ that goes into vaccines in general, writing for Forbes, William A. Haseltine, professor at Harvard Medical School and Harvard School of Public Health says that the vaccine protocols are designed to succeed. Haseltine notes that preventing COVID-19 infection isn’t even being tested. With world leaders and people like Bill Gates stating that we cannot return to ‘normal’ until everyone is vaccinated, it’s concerning that the vaccine trials are not concerned with if the vaccines prevent infection at all.

Prevention of infection must be a critical endpoint. Any vaccine trial should include regular antigen testing every three days to test contagiousness to pick up early signs of infection and PCR testing once a week to confirm infection by SARS-CoV-2 test the ability of the vaccines to stave off infection. Prevention of infection is not a criterion for success for any of these vaccines. In fact, their endpoints all require confirmed infections and all those they will include in the analysis for success,  the only difference being the severity of symptoms between the vaccinated and unvaccinated. Measuring differences amongst only those infected by SARS-CoV-2 underscores the implicit conclusion that the vaccines are not expected to prevent infection, only modify symptoms of those infected.

Essentially they’re only looking at the difference in severity between the vaccinated and unvaccinated, not whether one got infected and one did not as most people would assume is the purpose of the vaccine to begin with.

We all expect an effective vaccine to prevent serious illness if infected. Three of the vaccine protocols—Moderna, Pfizer, and AstraZeneca—do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.
The greatest fear people have is dying from this disease. A vaccine must significantly or entirely reduce deaths from Covid-19. Over two hundred thousand people have died in the United States and nearly a million worldwide. None list mortality as a critical endpoint.

The bar for these manufacturers to claim “effiacy” is so low that they cannot miss, meaning that not only will the public be subject to dangerous vaccines, but they’re not likely to even work.

Interim analysis success requires a seventy percent efficacy. The vaccine or placebo will be given to thousands of people in each trial. For Moderna, the initial interim analysis will be based on the results of infection of only 53 people. The judgment reached in interim analysis is dependent upon the difference in the number of people with symptoms, which may be mild, in the vaccinated group versus the unvaccinated group. Moderna’s success margin is for 13 or less of those 53 to develop symptoms compared to 40 or more in their control group. For Johnson & Johnson, their interim analysis includes 77 vaccine recipients, with a success margin of 18 or less developing symptoms compared to 59 in the control group. For AstraZeneca, their interim analysis includes 50 vaccine recipients, with a success margin of 12 or less developing symptoms compared to 19 in the 25 person control group. Pfizer is even smaller in its success requirements. Their initial group includes 32 vaccine recipients, with a success margin of 7 or less developing symptoms compared to 25 in the control group.

The second surprise from these protocols is how mild the requirements for contracted Covid-19 symptoms are. A careful reading reveals that the minimum qualification for a case of Covid-19 is a positive PCR test and one or two mild symptoms. These include headache, fever, cough, or mild nausea. This is far from adequate. These vaccine trials are testing to prevent common cold symptoms.

These trials certainly do not give assurance that the vaccine will protect from the serious consequences of Covid-19. Johnson & Johnson is the only trial that requires the inclusion of severe Covid-19 cases, at least 5 for the 75 participant interim analysis.

One of the more immediate questions a trial needs to answer is whether a vaccine prevents infection. If someone takes this vaccine, are they far less likely to become infected with the virus? These trials all clearly focus on eliminating symptoms of Covid-19, and not infections themselves. Asymptomatic infection is listed as a secondary objective in these trials when they should be of critical importance.

It appears that all the pharmaceutical companies assume that the vaccine will never prevent infection. Their criteria for approval is the difference in symptoms between an infected control group and an infected vaccine group. They do not measure the difference between infection and noninfection as a primary motivation.

Article continues at Forbes.com

 

Why are children experiencing an explosion in chronic illness?

Why are children experiencing an explosion in chronic illness?

Virtually every chronic disease has grown to epidemic proportions in our children. ADHD, allergies, autism, cancer, autoimmune conditions, diabetes, epilepsy, and the list goes on. With the dramatic rise of these chronic diseases happening over an infinitely small timeline in terms of evolution, the notion that the rise has been driven by genetics falls flat.

One in six children has a developmental disability indicating that something is affecting the neurological health of our children. Autoimmune conditions, ranging from eczema to arthritis tells us that something is causing our children’s immune systems to act out of order and inappropriately causing it to attack friendly cells inside the body. The prevailing medical dogma is that this rise in disease must be environmental and yet the majority of the industry refuses to look at one of the most obvious culprits – vaccination.

Following the 1986, Vaccine Injury Compensation Act, which provided vaccine manufacturers legal immunity for damage and death caused by vaccines, the vaccine schedule has more than tripled. In parallel to the rise of the number of vaccinations we’ve witnessed the greatest fall in children’s health in history.

In Canada, all types of allergies in children have increased six times since 1980. For more than a century, science has understood that repeatedly injecting foreign proteins (vaccination) reliably causes allergies.

In 1903, the French immunologist Nicolas Maurice Arthus published an eye-opening experiment (8): after the fourth subcutaneous injection of horse serum in rabbits, a local oedematous reaction occurred; after the fifth, it became purulent; and after the seventh gangrenous. In other words, an increased specific sensitivity followed repeated injections of a foreign protein that was primarily nontoxic.

The History of the Idea of Allergy

This fact underscores the importance of thorough, long-term safety studies for vaccinations. Not all adverse reactions will happen immediately but can appear over time especially in the case of autoimmune conditions. Informed Consent Network Canada demands that proper studies be conducted to prove vaccine safety. Until we stem the tide of chronic disease in children no stone, including vaccines, should be left unturned.

When the medical system is so clearly failing the health of our children, the fact that proper studies are not conducted on the vaccines we inject into children becomes much more distressing.

 

New Supercharged Shingles Vaccine Has Serious Problems

New Supercharged Shingles Vaccine Has Serious Problems

The new herpes zoster (shingles) vaccine, Shingrix, is produced by GlaxoSmithKline (GSK) and is being marketed as the welcome and best answer to preventing a painful bout with shingles. GSK’s Shingrix vaccine is in head to head competition with Merck’s shingles vaccine, Zostavax, licensed in 2006. The relentless advertising for Shingrix is difficult to avoid: It is blared over grocery store speakers, has taken the place of muzak on pharmacy or doctors’ office hold lines, and is aggressively being promoted by nearly the entire medical establishment.

Shingles is caused by reactivation of the chickenpox virus (varicella zoster) in a person who has previously had either natural chickenpox or has received the vaccine. Children or adults who get shingles suffer with a painful, blistering rash, usually on one side of the body. The rash and blisters usually last for two or three weeks and the nerve pain may persist for months or even years.1 The condition usually occurs in adults over age 50, which is why public health officials and vaccine manufacturers target that population for marketing shingles vaccines. However, shingles has also been diagnosed more frequently in children since the chickenpox vaccine was licensed and recommended for all healthy children in 1995.2

Two doses of Shingrix costs close to $300.

Since its approval in October of 2017, Shingrix vaccine has overshadowed the older Zostavax vaccine produced by Merck, which had been the only shingles vaccine available in the U.S. for more than a decade. Shingrix is reported to be up to 90 percent effective in preventing the development of shingles, compared to an estimated 50 percent effectiveness for Zostavax.3

Administrative Errors

Even among the vaccine’s most ardent supporters, however, the news about Shingrix hasn’t all been positive. In June, the Centers for Disease Control and Prevention (CDC) published a report discussing a significant number of administrative errors and serious injuries associated with the new shingles vaccine.4 Within the first four months of being on the market, the Vaccine Adverse Event Reporting System (VAERS) received 155 adverse event reports linked to Shingrix.

Several of the errors were attributable to vaccine administrators confusing the two shingles vaccines, which actually differ in significant ways. Merck’s Zostavax is a live attenuated vaccine (ZVL) that is given once as a single shallow injection, just under the skin (subcutaneous injection). GlaxoSmithKline’s Shingrix is a recombinant vaccine (RZV) that must be reconstituted prior to injection and is administered deeper into the muscle (intramuscular injection). Shingrix is given twice, with the second dose given between two and six months after the first one.

The reported errors associated with Shingrix included administration via the subcutaneous route, a mistake that usually caused significant injection site reactions including pain, severe itching (pruritis), and redness (erythema). Other errors reported were administering the vaccine to patients younger than 50, giving out the wrong vaccine information sheet (VIS), administering just the vaccine’s novel adjuvant without reconstituting it with the actual vaccine antigen, and mistakenly giving the shingles vaccine to a person who was supposed to get chickenpox (varicella zoster) vaccine.

New Adjuvant Turbocharges Immune Response

One of the challenges for manufacturers of inactivated vaccines like Shingrix is that they do not contain a live-virus, which traditionally have provoked stronger immune system responses. The strong immune system response reported for Shingrix is due to one of the new vaccine’s ingredients, QS-21 Stimulon manufactured by Agenus, Inc.

The novel vaccine adjuvant QS-21 Stimulon is a purified extract from the bark of the Quillaja saponaria vergreen, otherwise known as the soap bark tree.5 QS-21 Stimulon is an “immune potent” adjuvant designed to “turbocharge vaccines by strengthening and broadening immune responses (both T cell and antibody mediated) to a vaccine’s antigens.” The new adjuvant is currently under study for use in immune therapies against cancer, HIV, and malaria.6

Shingrix vaccine’s novel adjuvant system, AS01B, not only contains QS-21 Stimulon but also MPL (monophosphyoryl lipid a), an immune-stimulating fat. Shingrix ingredients (per dose) include 50 mcg of the QS-21 and 50 mcg of 3-O-desacyl-4’- monophosphoryl lipid A (MPL) from Salmonella minnesota, as well as 50 mcg of its antigen: recombinant glycoprotein E (gE), along with 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80.7

Severe Side Effects

Even when it is administered according to protocol, the Shingrix vaccine is very reactive. The vaccine’s side effects are known to be more severe than those associated with Zostavax, but public health officials insist the vaccine’s benefits are worth the risk of “skin rash, joint pain, flu-like symptoms, headaches and fatigue” commonly experienced by those who get it.8 Kathleen Dooling, MD of the CDC’s Division of Viral Diseases admitted that more than 70 percent of patients had pain and, “About one in six people experienced side effects so severe that it actually prevented their normal activities.”

In fact, the side effects of Shingrix are so severe that the vaccine’s promoters are concerned that many people will not be willing to go back for the second dose of the vaccine.

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