Determining Vaccine “Effectiveness”

It seems as though half the planet is rushing to be the first to receive the COVID-19 inoculation, while the other half couldn’t run away quickly enough. It’s no surprise considering the nature of the new type of vaccine (mRNA vaccines), never before able to be FDA-approved, being so unknown and therefore, undesirable. Here I will be breaking down the unorthodox way they determine “effectiveness” for these COVID-19 mRNA vaccines.

Unfortunately, many people are low-information people who don’t know and don’t care that this is not your traditional vaccine. I go deeper into the mRNA vaccines in my article, mRNA Vaccines Are NOT Your Typical Vaccine, so I wont get into the minutia here on how they function, but I do encourage you to head over there and read the rather informative article.

But what will it mean when a COVID-19 vaccine is declared to be “effective”? To the public the meaning of effective seems obvious. “The primary goal of a COVID-19 vaccine is to keep people from getting very sick and dying,” a National Public Radio broadcast said.

Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”

These seem like reasonable goals for the vaccine developers; however, the current phase III trials are not created with the intention of proving either, as you can see from the chart below. Not one of the current COVID-19 vaccine trials are designed to detect a reduction in any serious outcome (i.e. hospital admissions, use of intensive care, or deaths). Nor are the vaccines being studied to determine whether they can interrupt transmission, stopping the spread of the novel coronavirus.

Manufacturers’ Goals

The AstraZeneca trial (NCT04444674) lists the following primary endpoint: “Determine if there is a reduction of severe and non-severe COVID-19 disease in HIV-negative adults.” This deceptively suggests they actually are testing for a general outcome that includes non-severe disease, which you can see they are not.

Moderna called hospital admissions a “key secondary endpoint” in statements to the media. And a press release from the NIH reinforced this false impression, stating Moderna’s trial “aims to study whether the vaccine can prevent severe COVID-19” and “seeks to answer if the vaccine can prevent death caused by COVID-19.”

Contrary to what the drug manufacturer is trying to lead you to believe, Tal Zaks, Chief Medical Officer for Moderna, told The BMJ that their trial lacked “adequate statistical power to assess those outcomes,” saying, “the trial is precluded from judging [hospital admissions], based on what is a reasonable size and duration to serve the public good here.”

The problem they ran into was that hospital admissions and deaths from COVID-19 are too much of a rarity, among the population being studied, for any vaccine to effectively demonstrate a statistically significant difference in a trial of even the 30,000 people they had! The same holds true in regards to its known ability to save lives or prevent transmission because the trials are not designed to find out.

Moderna’s Zaks suggested, “would I like to know that this prevents mortality? Sure, because I believe it does. I just don’t think it’s feasible within the time-frame [of the trial]—too many would die waiting for the results before we ever knew that.”

We can’t forget though, Hotez’s second criteria for an effective vaccine: interrupting virus transmission. I expect many experts would argue it should be the most important test in phase III studies, especially considering that is what the general population understands that is what vaccines are meant to do.

“Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.” It is mind-blowing to me that this seemed like a reasonable excuse for not properly testing the performance of a vaccine meant to inoculate world-wide!

“Finding severe rare adverse events will require the study of tens of thousands of patients, but this requirement will not be met by early adoption of a product that has not completed its full trial evaluation,” Harvard drug policy researchers Jerry Avorn and Aaron Kesselheim recently wrote in JAMA. Yet as I wrote about in my article about the mRNA vaccine side effects, the CDC encourages pregnant and breastfeeding women to get vaccinated with no knowledge of the effects it could have on the mother or baby.

According to BMJ, “COVID-19 vaccine trials are currently designed to tabulate final efficacy results once 150 to 160 trial participants develop symptomatic COVID-19—and most trials have specified at least one interim analysis allowing for the trials to end with even fewer data accrued.”

According to Medscape’s Eric Topol, a outspoken critic of the trials, “these numbers seem totally out of line with what would be considered stopping rules. I mean, you’re talking about giving a vaccine with any of these programmes to tens of millions of people. And you’re going to base that on 100 events?”

No one would have expected that an enveloped respiratory virus that is spread by small droplets would rage in a hot and humid climate during the summer, a time when the flu is gone. No one would have predicted that it would cause this unusual multi-inflammatory syndrome in children; I know of no other virus that does that.

I think the most surprising aspect of this virus is that it causes vasculitis, but not because it reproduces itself in the endothelial cells that line blood vessels. I think the vasculitis is a function of the immune response, and a panel of cytokines and chemokines are causing that. As a consequence, you can have strokes, heart attacks, liver, kidney, and other distal organ disease.

Paul Offit, MD

 Judging Trial Outcome

“Number one, we have a bad outcome as our endpoint. It’s COVID-19 disease.” Moderna, not unlike Pfizer and Janssen, designed its study to “detect a relative risk reduction of at least 30% in participants developing laboratory confirmed COVID-19, consistent with FDA and international guidance.”

Number two, Zaks pointed to influenza vaccines, saying they protect against severe disease better than mild disease. To Moderna, it’s the same for COVID-19: “if its vaccine is shown to reduce symptomatic COVID-19, it will be confident it also protects against serious outcomes.”

This means they are not only hypersensitive in rating people as COVID-19 patients, but that their over-inflated numbers lead to the conclusion of the trials sooner, making the trials even less effective in showing outcomes of receiving the inoculation than previously described.

Al Sommer, dean emeritus of the Johns Hopkins School of Public Health, told The BMJ, “If they have not powered for evidence of benefit in the elderly, I would find that a significant, unfortunate shortcoming.” He rather disturbingly emphasized the need for “innovative follow-up studies that will enable us to better determine the direct level of protection immunization has on the young and, separately, the elderly, in addition to those at the highest risk of severe disease and hospitalisation.”

We have to generate those data. I can’t see how anybody—the Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or FDA decision-makers—would ever allow a vaccine to be recommended for that group without having adequate data.

I feel the same way about minorities. You can’t convince minority populations to get this vaccine unless they are represented in these trials. Otherwise, they’re going to feel like they’re guinea pigs, and understandably so.”

Paul Offit, MD

Vaccine Mandate?

For many people, only one question remains: Will Americans be actually mandated to get a forced vaccination?

According to public health and legal experts, the answer is yes, but probably not through a government mandate anytime soon, and more likely it wouldn’t be an order coming from the federal government.

Instead, private employers and states may place conditions on returning to or accessing workplaces, schools and universities upon whether they received the vaccine (then possibly mandate it once the FDA issues full approval, months down the road, but possible nonetheless). As you can see in the USA maps below, there are some states that do not allow exemptions from vaccines in their school systems.

“It’s much more likely that a private organization or company will require you to be vaccinated to get certain access to places,” said Arthur Caplan, a professor of bioethics at the New York University Grossman School of Medicine. “People worry about the president, governor, or county executive telling them what to do. I don’t think that’s going to happen.”

Unfortunately, I agree with Caplan wholeheartedly. Though there will be some power-hungry, fearmongering government officials trying to make this vaccination mandated for all, it will likely be the private sectors that force people to go against what their intuition and research is telling them, in order to stay afloat in a post-pandemic economy.

Zero Liability

Insurance Journal reported, “Americans who suffer adverse reactions to coronavirus vaccines that the U.S. is racing to develop will have a hard time getting compensated for injuries from the drugs.”

That’s because pandemic-related claims for vaccines will be routed to a rarely used federal program set up to encourage drugmakers to help combat public health emergencies. It spares pharmaceutical and device makers from costly liability lawsuits in exchange for taxpayers compensating injured patients — though it doesn’t guarantee there’s funding to do so.

My Body, My Choice

I, personally, am going to do everything possible in my power to make sure neither I nor my children are made to receive the COVID-19 mRNA vaccine. It is utterly unAmerican to force this on free people, violating our civil liberties and striking fear into our hearts in order to ease the fear in others. I will continue to speak out against the fear propaganda that the government and its entities are spewing out.

Please share this and my other articles regarding the mRNA COVID-19 vaccines to help keep people informed about what is really happening. We are in a digital reality war, and They are trying to distort our perception of reality to push us into willingly giving up our liberties. We must not allow them to win, and have to keep each other knowledgeable about reality.

God bless the United States of America.

Call to Action:

• Get/stay INFORMED AND EDUCATED
• Watch/read news from BOTH SIDES.
• PROTECT your family and fellow Patriots
• Engage in CIVIL DISCOURSE
• REFUTE misinformation
• DO NOT fall into the Third Party trap. Remember Ross Perot is how Clinton got elected.

This is a civil war between Communism and America. There is no more Democrat vs Republican right now. America needs to be united in the party of Patriots who believe in our constitution and the inherent right to Life, Liberty, and the Pursuit of Happiness.

The radical Left has thrown their hail Mary, and we need to get our heads in the game and intercept that pass before it’s too late. Whether or not you believe Orange Man Bad, The Republicans who followed President Donald J Trump are the only hope for remaining a constitutional republic.

NEVER FORGET: They are Rights enumerated to remind us and our government of our innate and indisputable liberties that are granted to us by our Creator, not our government; NEVER to be infringed or impinged upon by elected officials nor bureaucratic narcissists, ALWAYS as protection for We The People from tyranny and despotism at even the highest level of our hierarchical structure.

This page is a conservative-leaning blog that takes the facts from current events and gives objective information as well as my opinion on those facts. I am not an expert in any field, nor do I claim to give expert advice, but I will try to get you all of the evidence-based information I can find.