Thursday, October 28, 2021

The Biggest of Bets

Back in 2010 when Obamacare was being debated Nancy Pelosi made a statement that will long linger in history.

When being questioned about the wisdom of rushing the bill through Congress on strict party line votes without full transparency and a debate about what was in the bill, Pelosi said this.

"We have to pass the bill so you can find out what's in it."


This week an FDA advisory committee recommended the Pfizer Covid vaccine be authorized for "emergency use" for children ages 5-11.

The FDA and CDC are expected to follow the recommendation with formal authorization within the next week.

Interestingly, the FDA group conceded in its discussions about the vaccine that it does not know the long-term risks to kids.

One of the voting members said this as the reason for his affirmative vote.

He sounded like he was channeling Nancy Pelosi.

"We are never going to learn about how safe the vaccine is unless we start giving it. That's just the way it goes."

We are now openly experimenting on millions of children in a mass clinical trial?

It is true that all vaccine and drugs have to be tested at some point on humans.

However, these trials are usually carefully staged and limited to numbers necessary to balance clinical needs while limiting the risks to large populations groups if there are any adverse events or effects.

For example, the polio vaccine was first developed in 1952 but full approval was not granted for use for all children until eight years later.

A large trial was undertaken in 1954 but the administration of the vaccine was suspended in 1955 after it was found that some children were contracting polio from the vaccine produced from one manufacturer. 

This was true even though early evidence showed that the vaccine was effective. However, was it SAFE?

You can see how polio cases dropped after the introduction of the vaccine in this chart.

Have we seen anything that in any way resembles this chart with the introduction of the Covid vaccines?

For context, consider the fact that there are 28.5 million children in the United States between the ages of 5-11.

There have been 97 total deaths among children in this age group with Covid in the last 22 months.

Almost every one of these deaths has involved a child with a significant contributing comorbidity (cancer, heart defect, congenital abnormality, etc).


During the same time period there have been 5,716 deaths of children from all causes. That means that 98.3% of the deaths of children over the last 20 months have been from something completely removed from Covid.

The CDC reports that between March, 2020 and August, 2021 just 562 out of 28 million children had been hospitalized with Covid. Most had serious underlying medical conditions such as chronic lung disease, neurologic disorders or obesity. This was a slide that was shown at the FDA meeting that convened to discuss authorizing the vaccine for children.


I also found it interesting that 68% of hospitalizations were Black and Hispanic children. Is this because many in these populations do not have primary care physicians and are more likely to go to hospital emergency rooms for care? Is there another reason?

It is also likely that almost half of those hospitalizations involved admissions to the hospital for another condition and a positive Covid test was discovered when the child was admitted to the hospital. This was the conclusion of an American Academy of Pediatrics study of Covid cases for ages 0-17 earlier this year.

All of these data points makes me wonder why would we have even contemplated vaccinating children in the first place?

The risk to children from Covid is infinitesimal and we have known that for a long time.

The other interesting fact to contemplate is that CDC data indicates that children in the age 5-11 cohort are more likely than any other population in the United States to have been exposed to Covid and developed natural antibodies to the virus.

The CDC estimates that 42% of children ages 5-11 had infection induced seroprevalence as of June, 2021. This estimate was before the recent Covid infection wave we have seen over the last several months so that number is undoubtedly higher today.

Note that natural seroprevalence in the 5-11 age group is almost 3 times that of those in the 65+ age group.

Why are we vaccinating children with limited knowledge of the risks when the potential benefits are so much smaller than in the older populations?

When the polio vaccine was rolled out, who did we vaccinate?

Did we vaccinate everyone? No. 

I got the polio vaccine in the late 1950's but they did not vaccinate my mother, father and grandparents.

Do you know why that was the case?

They were not considered at significant risk because of prior natural immunity.

I had always wondered why polio spiked up so significantly after World War II in the United States. I found this answer in "The History of Polio".

It is likely that polio has plagued humans for thousands of years. An Egyptian carving from around 1400 BCE depicts a young man with a leg deformity similar to one caused by polio. Polio circulated in human populations at low levels and appeared to be a relatively uncommon disease for most of the 1800s.

Polio reached epidemic proportions in the early 1900s in countries with relatively high standards of living, at a time when other diseases such as diphtheria, typhoid, and tuberculosis were declining. Indeed, many scientists think that advances in hygiene paradoxically led to an increased incidence of polio. The theory is that in the past, infants were exposed to polio, mainly through contaminated water supplies, at a very young age. Infants’ immune systems, aided by maternal antibodies still circulating in their blood, could quickly defeat poliovirus and then develop lasting immunity to it. However, better sanitary conditions meant that exposure to polio was delayed until later in life, on average, when a child had lost maternal protection and was also more vulnerable to the most severe form of the disease.

Similarly, it seems that the strong immune systems of children are well suited to quickly fight off Covid based on everything we know.

Why then do we want to risk interfering with a vaccine that might somehow alter or damage the natural immune system with unknown longer-term consequences for the child and society? 

How many children were included in the Covid vaccine trials? A shockingly, low number.

All of the data below is taken directly from the FDA Briefing Document on the Emergency Use Authorization for the Pfizer vaccine to be administered to 5-11 year old children in the United States.

There were only 1,527 children in the main clinical trial (out of a population of 28.5 million children 5-11 in the United States) who were given the vaccine. There were an additional 757 participants who received a placebo in the trial.

The participants in the vaccine trial were only observed for efficacy and safety of the vaccine for a mere two months!

Two months with 1,500 children? That is the sum total of looking at the safety and efficacy of the vaccine?

What kind of clinical trial is that?

Most vaccine trials last for years. That was the case for the polio vaccine when the threat to children was far greater than that posed by Covid today.

Is it any wonder that the FDA committee member said we have to start giving the vaccine to children in order to find out if it is safe?

What were the efficacy results?

No children died from Covid in either the vaccine arm or the placebo group.

No children had to be hospitalized in either the vaccine arm or those who got the placebo. 

All cases were mild. There were no severe cases in either the vaccinated or unvaccinated groups.

There were 19 total confirmed symptomatic cases of Covid in the 2,250 in the total trial (.0084 infection rate).

3 were among those who were double vaccinated. 16 were in those that were not.

This equates to what Pfizer calculates to be a 91% vaccine efficacy.

However, in absolute numbers, the fact is that 741 of 757 placebo participants were not infected during the clinical trial. In other words, 97.9% were not infected with Covid despite the fact they were not vaccinated.

Yes, those vaccinated had a better result in not being infected. Only 16 out of 1,500 got Covid who were double vaccinated--about 1%--were infected over the clinical trial period. However, the trial went on for only two months. In adults, we are finding that vaccine efficacy wanes considerably over time and is low enough after six months that boosters are now recommended for many who have already been vaccinated with two doses.

A study by Cornell University researchers found that protection dropped to 20% 5-7 months after the second dose of the Pfizer vaccine.

A Swedish study on the effectiveness of the Covid vaccines shows that they have ZERO effectiveness after eight months and may actually INCREASE susceptibility to Covid infection after that. You can read an analysis of the the study here.

Protection is good for the first 90 days (the period the original vaccine trials ran for) but protection dropped quickly thereafter. The child trials were only run for 60 days.

The crucial question is whether the benefit of the vaccines are worth the risks for children?

Below is the actual model from the FDA briefing document on the EUA request for the Pfizer vaccine for 5-11 year old children on benefits/risk outcomes under different scenarios.

It projects that under most model scenarios 1 million children will have to be vaccinated to prevent one death from Covid.


The way models usually work, consider this a best case scenario for the vaccine.

The risks of the vaccine look particularly high for males.

Under Scenario 3, which assumes assumes Covid incidence similar to what we saw in June, it is projected there would be over 4x more hospitalizations with boys from myocarditis with the vaccine than from hospitalizations with Covid!

What about other long-term risks of the vaccines? These were not modeled because the fact is no one knows what the true long-term risks are of these vaccines. They simply have not been in use long enough to determine that. 

For a 75-year old, that unknown long-term risk may be outweighed by the near-term benefit of some form of protection against severe Covid and death.

What about a 5 year old who has an entire life ahead of them?

Nobody really knows.

Do the risks outweigh the benefits?

Every parent is going to have to make that judgment as it now stands.

If that is where it ends, so be it.

However, taking that step could inhibit the child's immune system from providing the natural protection against other competing respiratory viruses for the remainder of their lives ("Original Antigenic Sin").

For society generally, mass vaccination of children could prove disastrous as they are the essential reservoir of building herd immunity against this virus and any direct mutations.

This view is summarized in this substack post on the topic of Original Antigenic Sin and how this relates to mass vaccination of children.

The most dangerous thing to do, at this point, would be to vaccinate children. The virus is not a threat to them, and if they are infected by the new forms of SARS-2 that are sure to emerge every winter, we will begin to establish – through them and the as yet unvaccinated – the layered immunity that is the only way of coming to terms with SARS-2 in the longer term. As long as the vaccinators are permitted to continue their radical and increasingly insane campaign, though, nothing will improve. Indeed, their policies threaten to bring about a semi-permanent pandemic state for generations to come.


My personal judgment is that the risks of these vaccines for children FAR OUTWEIGH any benefits. That takes account of both individual and societal risks of the vaccines.

The problem that we will soon face with the FDA decision is that states, localities, school boards and others are undoubtedly going to take this action and use it to mandate the vaccines for children.

"The FDA and CDC say it is ok." "They say our children need this."

In so doing, free choice is going to be replaced with coercion, threats and public castigation.

The Oakland, CA  Unified school district has already set a January 1 deadline for students 12 and over to be vaccinated. The vaccine for those ages 12-18 is still only authorized for emergency use for these ages.


Students who do not take the Covid vaccine have to switch to an independent study program or unenroll from school.

70% of students in the school district are African American or Hispanic.

If you think the subject of vaccine mandates has caused division and discord already, you haven't seen anything that compares with what is coming if they try to mandate the vaccines for children.

You can be sure that parents who have chosen to not to take the Covid vaccine are not going to vaccinate their children.

However, there is undoubtedly a very LARGE number of parents who took the Covid vaccine who are not going to consider doing the same to their children right now.

Only 27% of parents in this recent survey suggest they are definitely going to get their child vaccinated.

30% say definitely not. 5% say they will vaccinate their children only if required.

Many parents right now are indicating that they want to take a "wait and see" attitude on whether to vaccinate their child. (33% in the survey above)

This includes this M.D., MPH scientist on Twitter who states that he is in that category and is happy to let those parents who are eager to knock down the doors to get their child vaccinated to allow him to see how the experiment unfolds.

I hope it goes well for those parents who line up first with their children and knock the doors down to get them vaccinated.

I hope it also goes well for our society.

However, I have found that placing bets based on HOPE rarely pay off.

And this looks to be an awfully BIG BET based on all of the facts and data before us right now.

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