Confusion abounds in the Covid world. A vaccine was approved by the FDA, but not the one in use. A Greek alphabet of Covid variants is loose. New lockdowns are spreading across the world while research shows they do nothing but kill economies. Masks are required in schools even though children are virtually without risk of infection, while masks have demonstrable harmful effects. Vaccine passports are out; vaccine passports are in. Vaccines are safe and effective; vaccines have killed thousands and don’t prevent infection. Employers and governments are requiring vaccination with a vaccine that doesn’t exist. The Delta variant is spreading like wildfire; the Delta variant is no worse than the flu. Everywhere we turn is chaos and contradiction. How do we begin to sort things out?
Multiple Agendas – Lots of Bias
There seems to be several groups involved, each trying to take control of the narrative. Assertions are flying everywhere. Obsolete data is being presented to support positions, while new data is ignored because it contradicts those positions but supports others. Misinformation is everywhere, and our own government seems to be one of the greatest sources.
In this article, we will try to make some sense of things and offer some perspective. We will also raise some questions that remain unanswered, but need to be asked. I expect that some will try to say this article is spreading misinformation, but the primary sources I use are from the U.S. CDC and FDA, with some from U.K. and Israeli governments. A few are from published professional research literature. If someone wants to call those sources “misinformation,” best of luck.
I won’t do much more than mention lockdowns and mask mandates. We knew early in 2020 that lockdowns did not work to prevent the spread of Covid, but instead would cause huge social and economic harm. Yet lockdowns proved popular among nearly every government worldwide. The infamous Dr. Anthony Fauci has changed his position on masks almost as often as most people change socks. The American Institute for Economic Research has published a number of excellent articles on Covid policies and effects, including: “Lockdowns Do Not Control the Coronavirus: The Evidence“, and a more recent one: “COVID-19 Mandates Will Not Work for the Delta Variant“. Both are well researched and include numerous links for those who wish to delve deeper.
Covid is Worldwide and Here to Stay
With Covid widespread across the globe, it is now part of the library of diseases humans will encounter probably forever. Australia and New Zealand are making futile and tragically misguided efforts to forestall exposure in their populations, when all they are doing is postponing the inevitable. Likewise, masks have proven less than useless for preventing the spread of infections, but are still popular among authorities who want to give the appearance of doing something useful, even if that something causes more harm than good. They also serve as a visible sign to distinguish the compliant from the defiant.
A Bit of History
Before we get to discussing vaccines, we need a bit of background on the history of Covid variants. Below is a chart from the U.S. Centers for Disease Control (CDC) showing how Covid has changed in these last several months, from mid-May to the end of August.
This chart shows how the mix of different Covid variants has changed over time. On the left side we see that in May of this year, almost all of the Covid infections observed were of the original Alpha type (blue). By mid to late June, however, roughly half of the cases involved the Delta variant (orange). Just a month later in August, the original Alpha has almost completely died out and only accounts for a tiny fraction of cases. The rest are nearly all Delta cases.
It is worth taking some time to study and understand this chart. The transition from Alpha to Delta is important in several ways, not the least of which relates to current vaccines. Much of the information available, and many of the authoritarian policies implemented across the world, is now obsolete. What worked before, often does not work now. The dynamics of Covid require a dynamic response beyond the capabilities of many of our public institutions.
When they were originally conceived, mRNA vaccines seemed a brilliant idea. They could be developed quickly, would be easy to tailor to a particular pathogen, would be simple to produce in quantity, and should have few side effects. Unfortunately, the early attempts twenty years ago were dismal failures.
The worst of the failures was something called Antibody Dependent Enhancement (ADE) that caused the laboratory animal subjects to die when exposed to the wild type pathogen against which they were supposedly protected. As it turned out, the “vaccine” was simply priming the animal’s immune system to overreact when they were exposed to the pathogen, so the animals were killed by their own immune systems.
After much work, the current Covid vaccines were developed so as to, hopefully, not cause the immune system priming observed before. I say hopefully, because it has not yet been determined if the current vaccines will not lead to ADE given exposure to the correct pathogen. It was part of the experimental protocol to look for such an effect, as well as for many other possible adverse effects. Normally such investigations take several years to complete, as some effects do not show up immediately.
The Covid Vaccines
The two most widely used mRNA vaccines from Pfizer and Moderna are both mRNA concoctions, and both have obtained Emergency Use Authorizations (EUAs) from the US Food and Drug Administration (FDA) We will focus on the Pfizer vaccine as it has recently obtained a form of approval from the FDA. The clinical trial protocol was filed November 20, 2020, with the FDA to obtain the EUA. Phase 3 trials were to continue to at least November 2022 before full approval could be granted. The actual protocol contains a number of interesting items.
In particular, section 5 lists who could be included in the trial, and who must be excluded. No-one below age 12 could be included in phases 2 and 3. No pregnant women were included and women had to agree not to get pregnant during the trial period. A number of common conditions were also grounds for elimination, including hypertension, diabetes, smoking, and obesity.
FDA Pfizer Approval
The Pfizer EUA was granted December 11, 2020. Just eight months later on August 23, 2021, the FDA granted a general use approval for the Pfizer mRNA vaccine – sort of. Aside from the fact that the approval was given sixteen months before the end of the clinical trials, the FDA did not actually approve the Pfizer vaccine currently in use under the EUA. According to the approval letter, the approval was granted to a German firm, BioNTech GmbH, under the name of COMIRNATY. It was to be manufactured and marketed by Pfizer. Interestingly, the Comirnaty vaccine is not available in the US, and is not expected to be available any time soon.
In a fact sheet prepared by the FDA, the following statement is given:
“The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.1″
Note 1 states:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”
In other words, the approval was given to the unavailable German version, while the current stockpiled US version is still subject to the EUA constraints.
The key is in note 1, where is says “the products are legally distinct”. One very important distinction is that under the EUA conditions, Pfizer is indemnified against liability for any adverse consequences, including deaths, resulting from their vaccine. The unavailable approved vaccine would be subject to the same liability exposure as any other approved drug. Given that there have been almost 14,000 deaths, 1,700 miscarriages, over 5,000 myocarditis reports, many under age 20, and well over 100,000 severe adverse events, a majority of them resulting from the Pfizer vaccine, it is small wonder that they would not want to be liable.
This disingenuous shell game approval of one vaccine while suggesting that another version is really the same thing, just legally different, has contributed greatly to confusion around vaccine approval and use. Even the CDC is participating in the deception in a statement on one of their webpages that states:
“On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval external icon of the Comirnaty/Pfizer-BioNTech COVID-19 vaccine for the prevention of COVID-19 disease in people ages 16 years and older. The vaccine continues to be available under emergency use authorization for adolescents ages 12 to 15 years, and for the administration of a third dose in some immunocompromised people. As of August 26, 2021, 203 million people in the United States have received at least one dose of a COVID-19 vaccine. 172 million people, or about 52% of the U.S. population, are fully vaccinated.”
The only FDA approved vaccine is one from Germany that is unavailable in the US, while the only one available in the US is one subject to the EUA constraints. Supposedly they are the same thing, just with different labels and different legal considerations. Is it any wonder that there is confusion around what has actually been approved, especially when our own government is contributing to the confusion?
Does It Work?
The situation might not be so bad if it could be shown that the vaccine actually worked. Pfizer applied for approval of its vaccine at the end of April. While the data it submitted to the FDA is proprietary and confidential, it could not have included data after the first of May. Going back to the chart above, we see that prior to May, almost all Covid cases were of the original Alpha variant. At the time the vaccine was developed, only the Alpha existed, so that was the variant targeted. The Pfizer EUA submission claims over 97% effectiveness, as might be expected against the Alpha variant. The CDC lists several effectiveness studies but none later than March of 2021 – a time when only the Alpha was prevalent. A CDC study published in August, but only using data up to the end of April claimed 96% effectiveness for the Pfizer vaccine. It is interesting that the CDC no longer lists a current percentage of effectiveness on its webpages. This might reflect the vastly different statistics of the Delta variant.
How to tell if it works – estimating effectiveness
Calculating an estimate of vaccine effectiveness is relatively simple. Given the rapidly changing statistics for Covid, daily, weekly, or at most, monthly data should be used. Take the total number of Covid cases reported for unvaccinated people in that time period, and divide by the number of unvaccinated people in the same period. Then do the same calculation for cases and numbers of vaccinated people. If the vaccine is effective, the vaccinated ratio should be smaller than the unvaccinated ratio. The amount by which it is smaller would be the effectiveness of the vaccine. If the ratios are about the same, then the vaccine has no effectiveness. It may turn out that the ratio for the unvaccinated is smaller than for the vaccinated population. In that case, vaccines are actually of negative value and people would be better off not getting vaccinated.
It is interesting to note that in the US, as of May 1, our CDC stopped reporting “breakthrough” cases in vaccinated people unless it resulted in a death or severe effect. The CDC web page that is supposed to report cases and deaths is unresponsive. Consequently, one will have to use data from elsewhere such as the UK, Israel, India, or other sources that are much more open about breakthroughs.
One thing about the vaccines is that they have a number of adverse side effects, including deaths. According to CDC data from mid July when the webpage was still functional, and using data from the VAERS system, in the previous two weeks, more people died in the US from the Covid vaccines than died from Covid itself. (2,800 Covid deaths vs. 4,155 vaccine deaths)
Editor’s Note: Don’t miss Part II of this 3-part series, coming tomorrow at The Blue State Conservative.
By David Robb
David Robb is regular contributor to The Blue State Conservative and a practicing scientist who has been working in industry for over 50 years. One of his specialties is asking awkward questions. A large part of his work over the years has involved making complex scientific issues clear and understandable to non-specialists. Sometimes he even succeeds.