COVID-19 Vaccine Protocols Reveal That Trials Are Designed to Succeed

"These trials seem designed to prove their vaccines work, even if the measured effects are minimal"

ModernaPfizerAstraZeneca, and Johnson & Johnson are leading candidates for the completion of a Covid-19 vaccine likely to be released in the coming months. These companies have published their vaccine trial protocols. This unusually transparent action during a major drug trial deserves praise, close inspection of the protocols raises surprising concerns. These trials seem designed to prove their vaccines work, even if the measured effects are minimal.

What would a normal vaccine trial look like?

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.

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.

We recognize that the influenza vaccine does not prevent infection with that virus, but does have a measurable impact on hospitalization and death. The moderate protections from the influenza virus can potentially be replicated and improved on with Covid-19, but only with extensive trials that ensure the efficacy of a future vaccine.

Vaccine efficacy is typically proved by large clinical trials over several years. The pharmaceutical companies intend to do trials ranging from thirty thousand to sixty thousand participants. This scale of study would be sufficient for testing vaccine efficacy. The first surprise found upon a closer reading of the protocols reveals that each study intends to complete interim and primary analyses that at most include 164 participants.

These companies likely intend to apply for an emergency use authorization (EUA) from the Food and Drug Administration (FDA) with just their limited preliminary results.

Interim analysis success requires a seventy percent efficacy.  For Moderna, the interim analysis includes giving the vaccine to only 53 people. Their 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 primary analyses are a bit more expanded, but need to be less efficacious for success: about sixty percent. AstraZeneca, Moderna, Johnson & Johnson, and Pfizer have primary analyses that distribute the vaccine to only 100, 151, 154, and 164 participants respectively. These companies state that they do not “intend” to stop trials after the primary analyses, but there is every chance that they intend to pursue an EUA and focus on manufacturing the vaccine rather than further thorough testing.

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.

A greater concern for the millions of older people and those with preexisting conditions is whether these trials test the vaccine’s ability to prevent severe illness and death. Again we find that severe illness and death are only secondary objectives in these trials. None list the prevention of death and hospitalization as a critically important barrier.

If total infections, hospitalizations, and death are going to be ignored in the preliminary trials of the vaccines, then there must be phase four testing to monitor their safety and efficacy. This would be long term massive scale monitoring of the vaccine. There must be an indication that the authorized vaccines are reducing infection, hospitalization, and death, or else they will not be able to stop this pandemic.

These protocols do not emphasize the most important ramifications of Covid-19 that people are most interested in preventing: overall infection, hospitalization, and death. It boggles the mind and defies common sense that the National Institute of Health, the Center for Disease Control, the National Institute of Allergy and Infectious Disease, and the rest would consider the approval of a vaccine that would be distributed to hundreds of millions on such slender threads of success.

It appears that these trials are intended to pass the lowest possible barrier of success. As this is being written, the FDA is poised to announce tougher standards for a Covid-19 vaccine in the near future. It is my hope that these new standards for an EUA will at a minimum include requirements for protections from infection itself, protections from severe virus-related disease leading to hospitalization, and a significant improvement in Covid-19 related mortality.

It is clear from these studies that the vaccines currently under trial will not be the silver bullet needed to end the pandemic. We must do all we can public health measures to control Covid-19 as China and other Asian countries have successfully done.

Source: Forbes

Subscribe
Notify of
guest
28 Comments
Oldest
Newest Most Voted
Inline Feedbacks
View all comments

Aurum Cimex
Aurum Cimex
3 months ago

Two hundred thousand deaths (if you believe the fraudulent death figures). Less than a third of the number from a bad flu then. I’m so scared I can’t wait to inject myself with a ghastly concoction of chemicals supplied by companies that have been prosecuted for every sort of criminality possible.

didactic1
didactic1
3 months ago
Reply to  Aurum Cimex

350 million residents in
US. 200,000 dead. Compared to real pandemics, this is a joke. Biden plan? Shut down forever, make Silicon Valley the ruling class.

The Viking.
The Viking.
3 months ago

Here is some interesting reading on the Covid-19 plandemic.
https://principia-scientific.com/proof-that-the-pandemic-was-planned-with-purpose/

chris chuba
chris chuba
3 months ago

This is unfair. Unless you go full Dr. Mengele and vaccinate a large group of people and then intentionally infect half of them, it will take a year to prove the absolute effectiveness of a vaccine but only a couple of months to prove its safety.

Let’s take the Russian study as an example. They have 40,000 volunteers where 30,000 get the vaccine and 10,000 a placebo and are monitoring both groups. The good news is that you are monitoring 30,000 people right off the bat to gauge the safety of the vaccine. The bad news is that in a country of 140M, you might have 18 out of 10,000 develop Covid over a 1 mo. period. This is going to take several months of monitoring before you can absolutely say that the group getting the vaccine isn’t just ‘lucky’. However, after a few months, you can make a good argument that it’s okay to distribute a safe vaccine that is likely to be effective. We do this with the flu vaccine every year.

voza0db
3 months ago
Reply to  chris chuba

Well… The only purpose of almost all vaccines is just profit.

Even the numbers for the profit machine “fly machine” are inflated and yet,
comment image

As for the OPERATION COVID… Clearly we don’t need any vaccine or special drugs!

comment image

(even if 100% of those deaths have nothing to do with alleged RNA “SARS-CoV-2”!)

didactic1
didactic1
3 months ago
Reply to  voza0db

You know who should ne vaccinated with this stuff? Gangbangers. Saves lives- money. Prison costs lowered.

AlexanderAmproz
AlexanderAmproz
3 months ago
Reply to  didactic1

Barbaric should visit Finland,
If like to learn the Civilisation meaning !

About a third of Finnish inmates are housed in open prison, and Finland’s Criminal Sanctions Agency says inmates who go through open prisons are less likely to be arrested again. The reoffending rate drops almost 20 percent.

In Finland’s ‘open prisons,’ inmates have the keys
https://www.pri.org/stories/2015-04-15/finlands-open-prisons-inmates-have-keys

voza0db
3 months ago

I’m aware of that Finnish approach… It really tries to bring to the surface COMPASSION. And that’s all a Uman Animal needs to evolve into a Human Being, COMPASSION.

didactic1
didactic1
3 months ago

Finns are not Americans. And take that as “racist”. So fong what.

Nod
Nod
3 months ago
Reply to  didactic1

,,!,,

Nod
Nod
3 months ago
Reply to  didactic1

Finns are so far up American butt, they smell of it. Gullible and obedient, just like the sheep in North America.

Nod
Nod
3 months ago
Reply to  didactic1

,,!,,

AlexanderAmproz
AlexanderAmproz
3 months ago
Reply to  didactic1

Americans aren’t Finns, but decadent Barbaric…. !

Georges Clemenceau said :
“The US went out Barbarism to jump in Decadence without to pass by Civilisation”

Brillat Savarin said :
“Tell me what do you eat, I will tell you who who are…”

71% Of Military Age Americans Too Sick To Join, Study Says
https://www.naturalblaze.com/2018/03/71-percent-military-age-americans-too-sick-join.html

Nod
Nod
3 months ago

Finns are obedient serfs. Enslaved to the same inequality that owns us all. They have is nationalism blinding them to the fact they have owners.. And the puppets they vote for are powerless demagogues.

And they are anti social and miserable. Only times I met outgoing friendly Finns (strangers) was when I went to a bar. They do like the drink. As to Racist ? One only needs to look towards the True Finn party. The gypsies perhaps?

I saw Somalian people harassed by Finns for no apparent reason. Then I saw a Somalian man physically abuse his wife in a mall, and no one did squat. Who cares ? All it took was a few words to put a stop to it.

Then we look at the refugees who fled from the NATO murder death cult. And many of them hated. Blaming these victims for their privations, brought about by PONZI DEBT.

Funny , I was in Tampere. There was an independence day dinner party for the ruling class and there was a demonstration. Hundreds of curious Finns watching a dozen or so malcontents trying to “storm the chain link gates” of the Tampere Talo.

I was walking our dogs with my wife, and we came upon it. Wow, loads of action with yelling, fence shaking and pointless harmless violence.

So they let it go on, and then a plain clothes cop who noticed us arrive said we should move towards the fence as there were 4 horses set to charge into the crowd. Not a mob, but a large group of dissatisfied Finns and curious onlookers. With children there. I could not believe it when they charged in.People flying like bowling pins. Right to the center where the malcontents (or instigator) played the part of the fool. . Then they charged back. Kids there. Kids there.

As I watched the herd clear, I noticed one of those cops on the horses leisurely canter into the center, where only a couple people remained, and as he circled, he reached down and tussled the hair of a demonstrator. Seemed like theater to me, but who knows.

So most of the Finns fled. but now there was a larger crowd of malcontents. Young people and now the police had given them a reason to be pissed off.

How many knocked over I wonder. They then marched, broke windows, and the herd and the newspapers applauded the police.

Obedient nationalists are prime meat for fascism.

Oh ya, I call bullshit, Finnish society is racist. In an impersonal systemic kind of way.

Money power rules. While Finns generally believe they live in a socialist democracy. As they are raped by inequality.

Finland, complete bankruptcy is generally only an option for corporate interests.

A scum bag creditors wet-dream.

“The debtor is not released from liability through bankruptcy, but is liable for pre-bankruptcy debts also with any assets received after the bankruptcy, if the company continues its operations. However, if a company is declared bankrupt, it in most cases ceases to exist.”

Office of Bankruptcy Ombudsman

Nope, here is Finland. exactly where covid has now brought the rest of the world. Debtor slaves are on their knees. And on the hook for life. 😛

didactic1
didactic1
3 months ago

Weak Americans will soon face starvation. Plant forests, dump the 300 million corpses. Obesity solved. Diabetes solved.

voza0db
3 months ago
Reply to  didactic1

Forget gangbangers! I would just use them on ALL THE SRF & Billionaires.

AlexanderAmproz
AlexanderAmproz
3 months ago
Reply to  voza0db

Basic Hygiene washing the hands had beat the past Pandemic, not vaccine !

Circumcision take away sexual sensibility 80%, not the soap !
================================================
Is Circumcision the Source of Jewish Angst? Genital Mutilation and Psychic Trauma
https://russia-insider.com/en/circumcision-source-jewish-angst-genital-mutilation-and-psychic-trauma/ri24861

voza0db
3 months ago

That’s too goddamn BASIC for the XXI Century…

comment image

Just washing the hands! Ahh!

AlexanderAmproz
AlexanderAmproz
3 months ago
Reply to  voza0db

Sedentary lifestyle, Air Pollutions fine particles, Pesticides,
and Junk-Food Salt, Sugar are provoking Cancers,
High-Blood, and Diabetes sickness’s good for Covidiot Death
by lack of immunity !

Sun, Exercises, Good Sleep, Clean Water, Fresh Air,
Healthy Food are essential for the immun system !

The Grotesque useless Masquerades could only be
a pneumonia contribution and Mental disturbance
at the best !

Hands are transferring the Viruses….
that why 3’500 years ago, Alep invented the soap
to wash the hands … !

1’500 years ago, Mohammad the smart vulgarised
the Torah & Bible and added washing mandatory
before physiotherapist prayers (lol)

Sicknesses and vaccins are mostly rubbish MSM
entertainment for Big-Pharma bonanza, sicker better !

Viruses & Bacterias is life, human being machinery is done
for that if you maintain it well !

voza0db
3 months ago

“Clean Water, Fresh Air, Healthy Food”… Unfortunately we’ve all made sure that none of this exists anymore.

Even in the most remote areas of this Planet we can find polluted Water, Soil and Air.

We, Uman Animals, cannot survive without Viruses & Bacterias… We are ALL ONE ORGANISM. Going after a part can only mean the ending of the Whole.

AlexanderAmproz
AlexanderAmproz
3 months ago
Reply to  voza0db

To Favour dishonesty, incompetences and worsening
everything is the UK/US irresponsible Imperial Cardinal rule
for Domination and quick easy money
=========================================
https://www.voltairenet.org/article197541.html

DIVERGENT INTERPRETATIONS IN THE ANTI-IMPERIALIST CAMP – PART 2

The US military project for the world

by Thierry Meyssan

While all experts agree that the events in Venezuela are following the same model as those in Syria, some writers have contested the article by Thierry Meyssan which highlights their differences from the interpretation in the anti-imperialist camp. Here, our author responds. This is not a quarrel between specialists, but an important debate about the historic change we are experiencing since 11 September 2001, and which is influencing all our lives.

Etc., etc…
https://www.voltairenet.org/article197541.html

=========================================
https://www.voltairenet.org/article175898.html

MADE BY THE USA

Manufacturing “Failed States”

by Edward S. Herman

The United States has mastered the art of undermining its targets by fomenting domestic terrorism, and then laying the responsibility on them for the crimes sponsored by Washington itself. This method affords it the possibility both to justify military intervention and to carry it out without risk. The well-oiled scheme described here by Edward S. Herman is now being applied in Syria.

Etc., etc…
https://www.voltairenet.org/article175898.html

disqus_3BrONUAJno
disqus_3BrONUAJno
3 months ago

The vaccine trials are designed the same way the IPCC produces studies.
Those who write IPCC reports are given the desired outcomes and then write the studies to support them.
All they need are a bunch of Ian Haydons and they could prove full immunity is provided by saline injections.

Cheatersneverwin
Cheatersneverwin
3 months ago

Fake vaccine for a fake virus

Padre
Padre
3 months ago

Motto is, if virus didn’t kill you, the vaccine should do the job!

voza0db
3 months ago

do not require that their vaccine prevent serious disease only that they prevent moderate symptoms which may be as mild as cough, or headache.

Well if that the goal THEY ARE FAILING!

Hutchison, a 44-year-old computational biologist in Utah, said he signed up for Moderna’s phase three trial because he’s healthy, physically fit and a big believer in vaccines. He specifically wanted to support Moderna’s effort, as he was intrigued by the company’s RNA-based approach. While still experimental, mRNA vaccines potentially offer faster development and production times, which could be a major benefit during a global pandemic that has led to more than 1 million fatalities.
“I had a high degree of confidence it would work and I wanted to contribute to the solution,” Hutchinson said.
After getting the first shot on Aug. 18, he said he felt a little under the weather for several days with a low-grade fever. He got his second shot at a clinic on Sept. 15. Eight hours later, he said he was bed bound with a fever of over 101, shakes, chills, a pounding headache and shortness of breath. He said the pain in his arm, where he received the shot, felt like a “goose egg on my shoulder.” He hardly slept that night, recording that his temperature was higher than 100 degrees for five hours.

One North Carolina woman in the Moderna study who is in her 50s said she didn’t experience a fever but suffered a bad migraine that left her drained for a day and unable to focus. She said she woke up the next day feeling better after taking Excedrin, but added that Moderna may need to tell people to take a day off after a second dose. She said other people in the trial have joined a couple of private Facebook groups and have shared similar experiences. She said members of the groups also reported a fever and pain in the arm similar to getting a tetanus shot, adding “you’re not going to be lifting weights or working out.”

So… It seems they fit quite nicely the criteria to be labelled “COVID-19”!

And ALL THIS on healthy animals! Imagine the FUN when screwed animal start receiving that fine and miraculous BG vaccine!

Le Ruse
Le Ruse
3 months ago

Simple !
I agree to take the vaccine only on condition, that Bill Goetz & family, plus all for it Politicians, Media celebrities take it first !
If they survive, then the vaccine is safe for me to take it . If they don’t survive then the country is safe !

David Bedford
David Bedford
3 months ago
Reply to  Le Ruse

I like your conditions..

Le Ruse
Le Ruse
6 months ago
Reply to  David Bedford

This should the condition that all of us should want !

Anti-Empire