The Vaccine End Game
"The process for COVID-19 vaccine strain selection to address current and emerging variants" is a hugely significant statement - here's why.
On 6 April 2022, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to discuss COVID-19 related items. The meeting announcement1 provides background, a link to the meeting on YouTube, and the agenda. Here’s the agenda for the April 6th meeting:
The committee will meet in open session to discuss considerations for use of COVID-19 vaccine booster doses and the process for COVID-19 vaccine strain selection to address current and emerging variants.
If you’ve been reading all of the posts on this Substack, you likely recognize the significance of the FDA talking about developing a “process for COVID-19 vaccine strain selection to address current and emerging variants.”
If not, this post will summarize the relevant information from those others, to see why such an innocuous sounding statement has a wide reaching and permanent impact.
Give this a read-through, and if you want to know more of the details go back and review the articles linked throughout this one.
Flu vaccines are special
The only vaccines that currently utilize the strain selection process are influenza vaccines. From An overview of the regulation of influenza vaccines in the United States (Weir & Gruber 20162):
Influenza virus vaccines are unique among currently licensed viral vaccines. Due to the constant antigenic drift of the influenza virus hemagglutinin (HA) and neuraminidase (NA) surface glycoproteins, the vaccines designed to protect against influenza illness must be updated periodically in an effort to match the vaccine strain with the wild-type viruses circulating in a particular season. (Weir & Gruber 2016)
Every year the flu vaccines are updated for the new strains (for more discussion of flu strains read Flu shots and useless journalists). The process of updating the vaccines begins with the World Health Organization (WHO) making recommendations for which strains to include. The FDA advisory committee then meets to finalize their own recommendation, and manufacturers of already licensed vaccines make flu shots for those variants, submitting supplements to their current licenses.
In the United States, licensed influenza vaccine manufacturers must submit a supplement to their license for review and obtain FDA approval before the updated version of the influenza vaccine containing new virus antigens can be distributed. (Weir & Gruber 2016)
Here’s the important part:
Such supplements to inactivated and recombinant protein seasonal influenza vaccines do not require additional clinical data specific for the new strain. (Weir & Gruber 2016)
The updated vaccines are approved without any clinical data. The only thing the manufacturers are required to do is submit an update to their previous vaccine submission.
The changing definition of vaccine
The article The CDC intern defines vaccine traces the changing definition of “vaccine” - the CDC has two different definitions on their own website, and one definition now covers the new drugs (although arguably the new messenger RNA drugs don’t meet the other definition).
By expanding the definition of vaccine, it now covers the new mRNA and the adenovirus vectored drugs. Just like recombinant protein vaccines they don’t contain any active virus - so approval of annual shots will be done without clinical data, just like current flu vaccines.
As a bonus, calling them vaccines also creates the impression they have the same risks and effectiveness as other, existing vaccines despite there being no long term data on the new class of drugs.
And COVID-19 will be around indefinitely, at least in the CDC morbidity and mortality data. This is due to the important relationship between influenza and pneumonia, both clinically and in how we report data about them.
What is pneumonia?
Every year people have and will continue to die from some form of pneumonia. This has been true for all of human history, only really improving in the twentieth century due to the introduction of antibiotics.
The article Nate the Pneumonia Gnome explains how pneumonia is a disease, not a pathogen, and simply means an infection or inflammation of the lung tissue. This can be caused by many types of pathogens, including bacteria, viruses and fungi - the point of commonality is the lungs. And the actual pathogen involved is determined in less than half of all pneumonia cases.
Highly sensitive PCR testing detects infectious respiratory viruses in a large percentage of even healthy people. Therefore many of these pneumonia deaths will be of people who also tested positive for viruses, including human coronaviruses.
In fact, respiratory viruses can be found in 20-30% of healthy adults. There's no such thing as virus free discusses a paper that compiled the results of PCR testing from many different studies. The authors found different types of infectious respiratory viruses are present in a large percentage of healthy, asymptomatic people.
Although rhinovirus was the most common, coronaviruses were found in a significant number of people as well. Rhinovirus causes about half of all common colds and coronaviruses cause about a third.
From influenza to pneumonia
Most of the deaths during the 1918 flu pandemic weren’t caused by the influenza virus. 1918 - a war, a movie, and a pandemic reviews a paper in which researchers tested frozen tissue samples and determined that most of the deaths were due to secondary infections of bacterial pneumonia.
This means they think people had the flu, which caused them to get a bacterial infection that led to fatal pneumonia. This is likely the reason the epidemics in 1957 and 1968 were not nearly as deadly, since by 1957 doctors had antibiotics to treat the pneumonia, saving many lives.
But the 1968 flu epidemic provided an important insight into how subjective the diagnosis of an illness can be. Once health authorities started warning doctors about the emergence of a new pandemic influenza strain, doctors started listing it as the cause of death (instead of pneumonia) even though that strain had not yet reached the U.S. So the reported number of pneumonia deaths decreased and flu deaths increased (by the same amount) for a flu strain that wasn’t even present.
It’s important to understand that a clinical diagnosis of flu does not require confirmation of the influenza virus. The CDC definition of flu is basically a mild fever plus either a cough or a sore throat. This means, for example, that during flu season many cases are attributed to the influenza virus just because it’s flu season.
Effectiveness of annual flu vaccines
The value of annual flu shots is questionable at best. Flubar: When the CDC meets the flu discussed a study funded by the NIH which found that from 1980 to 2001, there was no correlation between rates of vaccination and mortality for any age group.
Most of the justification for annual flu shots comes from observational studies (not randomized controlled trials), and researchers have pointed out serious issues with these studies. In some cases, an observational study will calculate a potential reduction in all-cause mortality of up to 50%, even though only 5% of wintertime deaths are attributed to the flu.
As already mentioned, these annual flu vaccines don’t undergo clinical trials at all. In fact, in an interview with The Atlantic, Anthony Fauci stated that doing randomized controlled trials would be unethical because that would mean some people would not be getting vaccinated.
This is circular reasoning - using this logic he first must assume the vaccines work. This assumption is then used to justify not testing them.
The latest pandemic emergency
The article Desperate measures shows the bar for what counts as a pandemic has lowered with each successive one. The 1918 pandemic resulted in an estimated 20-50 million deaths worldwide, but by the 2009-2010 pandemic the WHO had lowered the bar to only 123,000 worldwide deaths.
The emergency measures implemented for COVID-19 are based on little to no evidence. The 2019 WHO report on 18 different non-pharmaceutical interventions (NPIs) found that for 16 of them there was either zero evidence or a very tiny amount, and usually no randomized controlled trials at all.
One of the two NPIs with at least some evidence was masks, and that evidence indicates masks don’t work. Worse, as shown in Enough with the masks already we have reason to think the unnecessary use of masks by healthy people actually makes more of them sick. Randomized controlled trials of community mask use have consistently failed to show a significant benefit, and in a couple of trials the mask wearers did much worse then the non-mask wearing control groups.
As discussed in An Important Detail the reasoning behind the emergency pandemic measures was never that they would indefinitely prevent people from getting infected. The measures were intended to slow the spread of disease so hospitals wouldn’t get overloaded, and there would be time to develop pharmaceutical interventions (like antivirals or vaccines).
We are nowhere near having capacity issues in hospitals, and we have vaccines we are told are effective. So whether you think these NPIs work or not, the justification for using them ended a very long time ago.
Emergency Use Authorization of treatments
Since COVID-19 was declared a health emergency, that meant Emergency Use Authorization could be granted to new vaccines or other treatments. But how are the candidates for authorization selected?
Ivermectin: Wonder drug or instant death? discusses Ivermectin, which is a safe drug with a large dosage window - almost four billion doses have been administered to millions of people. Since there are no longer patents on it the drug is cheap and widely available.
Although originally an anti-parasitic drug, multiple research teams have tested it on viruses in the lab with positive results. Cheap and easy to obtain, very well tolerated in humans, and with some known antiviral properties, it would seem an ideal candidate for Emergency Use Authorization against COVID-19.
But far from authorizing its use, the FDA actively discouraged use of the drug. One possible reason for that is discussed in A Theory on Regulatory Oversight.
The failure to give EUA to Ivermectin becomes more clear when we compare what drugs and vaccines did and did not receive it. Hydroxychloroquine and Ivermectin, both of which have been safely used for decades, are passed over. A new antiviral drug like Remdesivir, which has never been approved for any use, is given EUA.
And of course three new vaccines, two based on messenger RNA and one using an Adenovirus vector, also received EUA - despite using very new technologies. But being new, these are all patent protected and very profitable for their manufacturers, with Pfizer alone making $36 billion in the first year.
And if this seems unbelievable behavior for a government health agency, On regulatory capture talks about evidence that government agencies respond first and foremost to wealthy, powerful people and the organizations they support - but they don’t respond to the policy preferences of the general public at all.
As agencies captured by the very companies they are supposed to regulate, both the FDA and the CDC make decisions based on the needs of those corporations rather than based on the well-being of the public.
A final word on the risks of universal vaccination
And on the subject of universal vaccination, Chicken plague goes into the details of how universal vaccination of commercial poultry against Marek’s disease has changed a disease that was rarely fatal into one that almost always is.
This was caused by the almost universal vaccination of flocks with “leaky” vaccines - vaccines that prevent symptoms but don’t prevent the spread of the disease. And as we now know, the COVID-19 vaccines are leaky vaccines, and this may be the thing that drives the evolution of new variants for which we need annual strain updates.
COVID-19 becomes Covid
We now have all the elements in place to understand how COVID-19 (Corona Virus Disease 2019) will become Covid, an endemic disease that is a new version of the current flu, and the long term vaccine plan for it.
Widespread use of leaky vaccines will drive the evolution of Covid variants (new strains). Covid will be declared an endemic disease and will essentially replace the flu.
The subjectivity of diagnosis will result in many pneumonia deaths being attributed to Covid instead of influenza or other viruses, making Covid a leading cause of death.
Annual strain updates will be needed for the new vaccines, due to the rapid evolution of the new Covid variants. This process will use the current flu vaccines as a model.
Under this model the new vaccines will continue to bypass the standard approval process and clinical trials. And just like the flu, we will never know if the vaccines actually reduce mortality.
Covid vaccines will be placed on the CDC vaccination schedule, and annual vaccinations will be required for school and many jobs.
The lifting of unnecessary pandemic restrictions is tied to rates of vaccination, aiding the illusion of vaccine effectiveness. Because they are politically useful they will be occasionally reinstated, reinvigorating fear of Covid.
The only approved treatments are patent protected, so this creates a long term multi-billion dollar, annually recurring, revenue stream with zero liability risk.
Review and wrap-up
Pneumonia is a disease that has always been with us, and always will be, although the discovery of antibiotics in the twentieth century resulted in a drastic decrease in mortality. Pneumonia can be caused by one pathogen, or several pathogens simultaneously, but in most cases the pathogen isn’t determined.
Highly sensitive PCR testing detects infectious respiratory viruses in a large percentage of even healthy people. Therefore many pneumonia deaths will be of people who also tested positive for viruses, including human coronaviruses.
Pneumonia deaths will be increasingly attributed to Covid instead of influenza or other causes of pneumonia. Many will be presumed positive simply because it’s Covid season. This is how many influenza deaths are determined currently.
Rather than encouraging other types of treatments, the approved preventive measure for Covid will be vaccination. This is despite those other treatments being potentially very effective at reducing mortality.
Every year the FDA will approve one or more strains for that year’s Covid vaccine to combat what is now an endemic (always present) and rapidly evolving virus.
Only a tiny number of manufacturers will possess authorized or approved COVID-19 vaccines, and no clinical trials will be required before marketing them. These vaccines will carry no liability for the manufacturers, since they are using the FDA recommended strains.
The vaccine makers will continue to push for use in children, until the Covid vaccines are added to the CDC vaccination schedule and made mandatory wherever possible, such as for attending school.
The use of Covid vaccines will be treated as the reason why emergency measures like masks and lock downs are no longer required, rather than admitting those measures were only intended to last a few weeks at most. This will encourage the average person to get annual vaccinations.
The Covid vaccines suppress symptoms but don’t prevent transmission. Mass vaccination will drive variants, and may keep some of the worst ones from being eliminated through natural evolution. This could result in humans being dependent on these vaccines.
The pharmaceutical companies will sell hundreds of millions, if not billions, of these vaccines every year. This will be a massive and permanent recurring revenue stream with zero downside for the pharmaceutical companies.
Whether or not this was the goal from the beginning, Covid is now the New Flu.
Information can be bought, but knowledge must be earned.
Weir JP, Gruber MF. An overview of the regulation of influenza vaccines in the United States. Influenza Other Respir Viruses. 2016 Sep;10(5):354-60. doi: 10.1111/irv.12383. Epub 2016 Mar 24. PMID: 27426005; PMCID: PMC4947948. https://pubmed.ncbi.nlm.nih.gov/27426005/