Being Fully Vaccinated Does Not Mean What You Think It Does
Let's get down to brass tacks on how to better manage COVID.

Being Fully Vaccinated Does Not Mean What You Think It Does

Unfortunately, being Fully Vaccinated Does Not Mean What You Think It Does. Being fully vaccinated is a good thing for you and for those around you. But for a host of reasons, it does not mean what you might think it does.??

No matter the kind, full vaccination does not provide lifetime protection or even a year's protection under the best of circumstances. Instead, it offers monthly decreasing protection until it allows for almost no protection for you or for others with whom you come into contact by the eighth month.?

This ever-declining value of full vaccination is something about which virtually no one knows, except now in the context of the need for booster shots. As a 50+ year health and health and healthcare risk management expert who was formerly a leader of the FDA and a member of the Harvard faculty, I have repeatedly expressed my concern about this lack of public understanding.?

Some would say there is a time for withholding information to create the greater good of getting more than a majority of Americans fully vaccinated—to save lives. For a while, this is fine.

But the time for this has long passed. And our leaders, including our public health officials, should now be making widespread public announcements, at least on TV and radio, correcting any false impressions they have left in the minds of many Americans. It is now a more important value to restore confidence in our government leaders, especially our public health leaders.

What's the rest of the story, and what are some of the additional facts worth knowing?

First, vaccination errors can occur even in the best of circumstances, which are rare when working in the field instead of as part of a clinical study, where nurses or highly qualified others administer vaccinations. At the end of two weeks, even before the effectiveness of full vaccination begins to erode quickly, post-administration, full vaccination does not give you the 99% protection that is asserted based on clinical trials.?

This immediate erosion of apparent effectiveness comes from many sources.?

For example, in the field, there are such net-effectiveness degrading things as:?

(a) Expired or mishandled (poorly shipped or poorly stored) vaccines.?

(b) Administrator error.?

(c) In the case of self-administered at-home or at-work tests (which I have advocated globally for decades, but they do have a few shortcomings that have not yet been "patched"), user error and user fraud, and/or "proctor" (observer) error or fraud.?

(d) Breakthrough infections where the virus "breaks through" the barrier to it that full vaccination otherwise provides. For some unknown reason, possibly infection already started at the time of vaccination or started between the first and second dose or failure of the vaccine "against this variant or for this person," these breakthroughs are serious matters. Moreover, the breakthroughs often occur enough to consider them when doing a health and healthcare risk management analysis.

Second, suppose you might be willing to assume that all the factors in the above paragraphs together mean something critically important. They suggest that at the very outset, the effectiveness of full vaccination is 90%, not 99%, which still is an astounding number and miracle of modern science. But it is a shrinkage that is a likely "fact." Accordingly, we must deal with it while risk managing the disease's spread. In that case, we must calculate from there.?

And, if you assume that the effectiveness of the full vaccination deteriorates equally over the next eight months, which it probably does not, but it transforms the point into one far easier (and more easily understood) for me to make. In four months, the full immunization that you received only protects you and the others with whom you come in contact, only at best about 50% of the time (still a miracle) if the connection made is in a closed facility and the contact is made within 20 feet if you both are unmasked. This disclosure is shocking information for most people. 50% protection for self and others? How can this be?

For example, scientists or lay news reporters say that the virus infects many attendees (upwards of 30% or more) at some wedding or graduation parties held at small restaurants or at homes.?

This bug, especially its Delta and Omicron variants, is highly contagious. Much more so than the Flu or the Common Cold. It spreads quickly and broadly. If it were more deadly to healthy young adults and children, no one would risk attending such entertainment events. And if they understood how quickly and readily that once infected, they might spread the disease to older and less healthy individuals; it might frighten them.?

If these highly resistant to contagion and harm young people become carriers, serious injuries might occur. Their parents, grandparents, or older adults living next door (who they only visit at home for just 15 minutes once a week) are at significant risk or harm, especially if these loved ones have diabetes or have heart, brain, or lung disease. In addition, this less resistant state to infection, and severe risk of harm if infected, might apply to the dozens of people for whom an infected young person primarily cares.?

For more enlightened individuals who do not want to spread the disease to anyone, including strangers, the size of the population of concern would contain far more people. This group might include the entire set of people the young person contacts each day, either directly or indirectly, through an almost ever-increasing chain of infected people. The young person is the initiator. Depending on the enlightened person's profession, this group might eventually include hundreds of people before it flames out.?

If they knew better, both kinds of young people, both enlightened and unenlightened, would refuse to attend such closed facilities, small rooms, entertainment events.?

"Spreaders," from "Typhoid Mary" (a historical infectious disease figure of great prominence) to "Joe the Plumber" to "Pastor Jack" to "Machine-Worker Tim" to "Warehouse/Distribution-Center-Worker Mike" to "Teacher Linda" to "Government-Worker Jim" are dangerous people to be around, especially indoors. That is clear.

Third, for some unknown reason, possibly because they talk louder or more profound, or cough more during conversations than most other people, who knows, some spreaders are what are called "super-spreaders." Spending an hour indoors with them is like being indoors in a small facility with someone walking around with a bomb in his hand—or worse, if he is asymptomatic, in his back pocket. "Asymptomatic" spreaders and super-spreaders are even more dangerous to self and to others than other spreaders.?

And Asymptomatic spreaders which have pre-entry tested negative are the most dangerous of all. You have no chance of detecting them by other means than proper re-testing. By definition, temperature checks don't work. And watching for sneezes, coughs, and other physical signs of infection is also, by definition, not available, facility pre-entry or post-entry. If testing labels them to be a negative rather than a positive, when they really are a positive, instead of just a tiny bomb walking around, they are a well-concealed explosive that is let "inside the gates." They can do even more significant spread of harm.?

Fourth, given (or in some cases regardless of) what I said earlier, all those willing to be vaccinated, and are of the correct age, should be vaccinated. Even roughly 50% protection of self and others is a Godsend. But no one should be fooled into getting vaccinated, and neither the government nor employers should force an employee into doing so. I have often written about why solo mandated vaccination programs are not just unfair. They are prejudicial because many front-line workers who for just cause have refused to be vaccinated are low-paid Blacks or Hispanics.?

Pressuring, threatening, or even firing employees without giving them a reasonable option to get fully vaccinated, such as weekly testing, is beyond unfair. It is an abomination. CEOs and employers who have used or continue to use solo vaccination programs are in serious trouble ethically, morally, and legally. Read my earlier papers if you want to know how much trouble and why. They ride or once rode a very dangerous—to the CEO, Board Chairman, and enterprise—wild stallion. "Half-assed safety programs hurt everyone involved.

What's more, I believe solo vaccination programs are unconstitutional under the US Constitution and possibly some State Constitutions. And if not, they should be. But thanks to President Biden, recently there is a flip in the story.?

Suppose employers also offer employees an enlightened testing program option and reasonably apply that program (proven through recording and, when needed, presenting evidence of strict management, reporting, and enforcement). In that case, I believe the optional testing program converts the unethical, immoral, prejudicial, illegal, and unconstitutional solo mandated vaccination program into a very thoughtful "hybrid safety program."?

Fifth, I applaud the President for identifying and creating this public policy incentive. The new OSHA COVID Rules (regulations) will, with an 80% probability, go into effect by this coming??March. Only the federal courts might stand in the way. Historically, the Supreme Court gives great deference to Presidents' emergency health and safety actions.?

Besides, once the Supreme Court sees President Biden's actions for what they are, he likely will win. They are hybrid-program actions, and not as opponents, and unbelievably, some supporters, have mischaracterized them thus far—as solo mandated vaccination programs. How can they be so blind to the balance of the Rule??

Once the Supreme Court sees this, the Court will support them with a high level of certainty, even if the Court does not feel compelled to give deference to the Presidents' actions. In other words, the President has two legal ways to win. And he has proponents of sound public health policy, like me, for what that is worth, on his side to boot.

To those who expected me to oppose the new OSHA Rules, I only say: I believe the new Rules are an excellent start.?

Sixth, but, like every first version of an OSHA rule or any other regulation, over time, government leaders, academic policy leaders, or industry leaders might like to see the Rules "upgraded." By observing and spotting problems with the Rule as it is applied and enforced, leaders might spot the need for specific changes. That is a good thing, not a bad thing. We cannot let "the perfect drive out the good."

And by studying the impacts and evasive actions the Rule might create during use, the need for other improvements can be assessed and artfully made. But, of course, OSHA knows they must use the "Goldilocks Model" in making such upgrades--"not too hot and not too cold." Only then might the Rules become a better and better set of rules over time.?

One sound way to do this soon is by eliminating the employee's duty to pay for once-a-week testing. The current employee burden likely will cost around $100 per test per week for a top-of-line, immediate result, at home or at work hand-held test similar to a low-cost pregnancy test.?

Thanks to my and others' unending and winning efforts to lower the cost of manufacture per test of widely available top-quality testing, prices of appropriate testing are much better. Then (roughly three years ago), good testing was only available for $350 per test. Since then, developers/ manufacturers of reasonable alternatives to big-box tests have lowered the price to around $100 per test.?

Even at $1,200 a year, this cost is still tricky for a low-paid front-line worker to afford. Accordingly, over the next six months or so, I expect one or both of the following to occur:?

(a) Many enlightened CEOs and employers will, for the public good, voluntarily pay for, or at least heavily subsidize the payment of, the $1,200 per year. And astute CEOs and employers, at least, will soon follow. These quick followers will do this to cut down on risks of?much-feared:

(1) Employee unrest followed by loss of productivity.

(2) Unionization.?

(3) Employee lawsuits.

(4) CEO and/or employer brand deterioration.?

Again, enlightened CEOs will lead the way. Others will almost certainly follow, whether OSHA makes a revision to the Rule mandatory or not.

(b) The Rule will be modified by the President (most likely)—or OSHA or the Congress will revise it on their own—so as to require employers to pay all or half of the $1,200, at least for workers who receive payment of less than some sum, such as $60,000 per year ($5,00 per month).?

Seventh, for some inappropriate reason, call it what you will, opponents and even some supporters of the President's Rule are in most cases leaving out of their spirited (some might call them fervent) discussions of the new Rule a crucial part of the President's carefully crafted regulation.

Both its opponents and some of its supporters seem to be overlooking the third leg of the President's creative health policy chair, without which the "chair" will not work. This third public health policy leg is vital.?

The Rule also requires employers to offer much beyond an optional testing program. The third public policy leg is that employers must provide an optional testing program that is both reasonable and one that an employer reasonably and equally applies to everyone.?

The Rule requires, either expressly or implicitly, an employer to give OSHA proof of proper and equal application of the testing program in the form of frequent, very detailed employer-generated reports. These reports must be sufficiently detailed, clear, precise, and accurate to prove to OSHA that the employer is strictly managing and equally enforcing the program for (and to) all employees of every class at the same time.?

Otherwise, the employer's Safety Program is not a qualifying hybrid program. In this latter case, OSHA imposes very stiff fines for each error made by the employer, whether intended or not.

Eighth, I applaud the President for taking this sound policy step. His new public health policy makes matters much better. Without it, OSHA could not (or likely would not, given the strong opposition to it) compel employers to create legitimate hybrid COVID-19 and variants Safety Programs.?

The President's new Rule cleans up an expanding mess. In sum, it is a sound public policy intervention.

That is all for now. You get the point.

Best,?

John

John Norris, JD, MBA

Chairman and CEO

Safely2Prosperity?(S2P)

Healthcare Risk-Management Innovations

Phone: 617-680-3127

Email:?john.norris@safely2prosperity

LinkedIn:?/company/safely2prosperity

Website:?safely2prosperity.com

__________

? 2021 Safely2Prosperity LLC and John Norris, JD, MBA


Hon. John Norris JD, MBA

FDA Former #2; 20x Board Member; Executive Chair Safely2Prosperity; formerly managed ~14,000 EEs and ~$6B budget; ~30,000 LinkedIn followers; Former Harvard Life Sci and Mgt Faculty Member; facilitated raising $Billions

3 年

Thanks for your support, Guys. Best, John

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Hon. John Norris JD, MBA

FDA Former #2; 20x Board Member; Executive Chair Safely2Prosperity; formerly managed ~14,000 EEs and ~$6B budget; ~30,000 LinkedIn followers; Former Harvard Life Sci and Mgt Faculty Member; facilitated raising $Billions

3 年

Thanks for the 100 Views of my Full Article in just a few hours. Tomorrow, I will publish a quick summary in the form of a Post. My Posts sometimes receive thousands of views (the MAX was roughly 5,000 views, as I recall). Views are important to get the word out. Thank you for your views of the full article. Please keep an eye out for the Post. Best, John

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