Safe and Effective?
What the smallpox vaccine can teach us.
Author: Robert W Malone MD, MS
Date: 2022/03/15
Keywords: hot-vaccine, warm-base-manufacturing, response-surface,
With the reveal that the objectivity of the CDC (and US HHS) has become both
1. politicized by the executive branch and
2. compromised by the pharmaceutical industry
, we have to come to terms with living in a world in which we can no longer take governmental public health pronouncements as gospel truth. Those of us who are thinking for ourselves (and our children) now need to make personal assessments and decisions about COVID-19 vaccines, and then booster vaccination, and then boosters again. As we all assess the advice of HHS, CDC, NIAID, Dr. Fauci, White House Advisor Dr. Francis Collins, the Surgeon General, the FDA, and of course Pfizer, let’s briefly revisit what many consider to be history’s most effective vaccine: the smallpox vaccine produced from variola.
Smallpox kills, and it has been eradicated from the world by use of a higly effective vaccine (with the exception of samples stored in various freezers). It was (is?) a far more serious threat than SARS-CoV-2, in terms of death and disease. In order to understand the science behind vaccines, one must understand the strategies behind vaccination campaigns, and the smallpox vaccines provide a great case study.
Vaccinia (cowpox) virus is closely related to smallpox (variola) virus, and Jenner (in 1796) is often credited with discovering that milkmaids (exposed to cowpox) were resistant to Smallpox disease, and then actively vaccinating against variola using vaccinia virus. The historic smallpox vaccine product principally credited with eradicating Smallpox was labeled as Dryvax, (Wyeth Laboratories, Inc.- formally discontinued in 1982) and was prepared from calf lymph using the New York City Board of Health (NYCBOH) strain of vaccinia. What that means is that the skin of calves were infected with the NYCBOH vaccinia, resulting in widespread infection and a sort of weeping exudate on the skin of the calves as the virus replicates. The calves were loaded into a mechanical holder and the exudate (with the virus) was scraped off (using something that resembled a sweat scraper used for horses) and “processed”, placed into glass vials, freeze dried, and then sealed with a standard stopper. The quality control on the “processing” was pretty crude, and I have personally seen legacy vials of Dryvax that included calf hair in the final vialed product. The vials were shipped out, and then reconstituted with a diluent (saline) and a “bifurcated needle” was dipped into the solution and then repeatedly poked into the skin (typically over the deltoid muscle - the shoulder) of the vaccine recipient, resulting in the typical round smallpox vaccine scar.
The art and science of vaccinology teaches that vaccines can vary in both safety and effectiveness. That this is a sliding scale for which
1. disease severity,
2. pathogen infectiousness (transmissibility, or Ro) and
3. safety of the vaccine product
all must be simultaneously optimized, resulting in a three dimensional plot (or “response surface”). The teaching is that if a vaccine is to be given to the general population, it has to have a low adverse event profile (be very safe), particularly if the disease is generally thought to either have a lower risk profile or infection is a rare event. In general, a more “hot” vaccine, in other words one that typically has a more serious adverse event profile, will also be better at preventing infection. In the case of a highly infectious, highly pathogenic virus, the risk profile of the vaccine may be greater - in order to achieve disease people contracting the disease and with the ultimate hope of disease eradication. The licensed Merck Ebola vaccine is an example of a relatively “hot” (reactogenic) vaccine which is only deployed in populations at high risk during an Ebola (highly infectious and pathogenic virus) outbreak. Benefits versus risks. If the pathogen is particularly nasty, then it becomes more acceptable to deploy a vaccine that causes some degree of disease. Makes sense?
There is another important element in the national vaccine program, which is the requirement to keep the vaccine production facilities up and running. These facilities are producing a biological product, they must be kept in production or the process for re-licensure is onerous, if not impossible. In the case of seasonal flu, one of the justifications for the yearly vaccine is to keep the manufacturing plants running and ready for business in case of a truly severe strain of flu or some other, unknown pathogen become a threat. If those facilities are moth-balled, they can’t be brought back on line quickly. Bet you did not know that. One major reason for pushing annual influenza vaccines is to maintain influenza vaccine manufacturing capacity. The industry term used is “warm base manufacturing”. Of course, this results in a very nice annual “cash cow” for the vaccine industry, one which gets annually milked for a tidy guaranteed profit. The term “rent seeking behavior” applies. The same is true of the various “biodefense” vaccines and products which are maintained in the “strategic national stockpile”. In the context of Smallpox, these include ACAM2000. These products have half lives, which is to say that even though they are (hopefully) not used, they still have to be replaced every few years. Again, nice predictable profit. The corporation “Emergent Biololutions” has become particularly adept at exploiting this “market opportunity”, and has managed to monopolize many of the biodefense-related vaccines and products which the US Government purchases for the Strategic National Stockpile, including ACAM2000.[i]
So, there is more than one reason to vaccinate the entire population on a regular basis, and the government basically props up the entire vaccine industry with what are functionally major annual subsidies. Once a policy decision is made to acquire a vaccine product or establish a “standard of care” involving a vaccine, it is never re-evaluated. Any politician or government administrator that even considers rethinking whether a vaccine policy makes good sense is confronted by the specter of being blamed for any outbreak or cases of that disease that may arise - regardless of how (in)effective or risky that vaccine product may be. So, a combination of public policy realities and regulatory barriers to entry (very, very difficult and expensive to demonstrate improved effectiveness or safety for an improved vaccine when there is already an accepted vaccine on the market) make the vaccine business particularly lucrative and predictable for the large manufacturers that produce licensed vaccines.
What is Smallpox?
Before smallpox was eradicated, it was a serious infectious disease caused by the variola virus. It was contagious—meaning, it spread from one person to another. People who had smallpox had a fever and a distinctive, progressive skin rash.
Most people with smallpox recovered, but about 3 out of every 10 people with the disease died. Many smallpox survivors have permanent scars over large areas of their body, especially their faces. Some are left blind.
Thanks to the success of vaccination, smallpox was eradicated, and no cases of naturally occurring smallpox have happened since 1977. The last natural outbreak of smallpox in the United States occurred in 1949.
First, note that the modern smallpox vaccine is not the same as the inoculation that has been throughout history.
The earliest smallpox prevention efforts date back to at least the 10th century in China, when physicians found that nasal inoculation of susceptible persons with material from smallpox lesions would sometimes provide immunity. The practice of inoculation appears to have arisen independently in several other regions prior to the 17th century, including Africa and India, but the practice did not gain popularity in western Europe until the 18th century. The wife of an English ambassador, Lady Montagu, observed inoculation in Turkey, and later had her own child successfully inoculated during a smallpox epidemic in England. In this procedure a lancet or needle was used to deliver a subcutaneous dose of smallpox material to a susceptible person. The procedure, also known as variolation, was controversial. It generated immunity in many cases, but it also killed some people and contributed to smallpox outbreaks.
In other words, smallpox is deadly. Historically, 30% of the people who contract the virus die. Many people were maimed and disabled permanently.
That said, the designers of this vaccine wanted it work to not only stop disease, but eradicate it completely. So, the smallpox vaccine was designed to be “hot.” The adverse event profile is much greater than say, that of the influenza vaccine. It is designed to
1. stop infection and
2. as much as possible, transmission.
With flu, the vaccine is only partially effective, because otherwise the cure would be worse than the disease for most healthy people.
The CDC knows this. But they have a mission to stop vaccine hesitancy. To do this, they promote vaccines and the vaccine enterprise as safe and effective. Full stop. No exceptions or questioning tolerated.
The smallpox vaccine is old enough that its risks are well known, and those data can be used to help us better understand how the CDC assesses vaccine safety. It is naive to think that all vaccines are “safe” – no matter what and no matter which vaccine. Unfortunately, officials at the CDC appear to have a belief system that all vaccines are “safe and effective”, which belief has become more a view of a world, a sort of object of faith (catechism) than objective science.
Frankly, positioning this as a statement of faith, a sort of ritual endorsed by annoited high priests of public health, gives these officials benefit by removing any reason to doubt or question. The determination and public statements that most vaccines are “safe and effective” is a promotional tool. And this propaganda is not holding up to scrutiny. People are becoming more and more distrustful of the whole vaccine enterprise, and for good reason. It is time that public health be honest and transparent. Vaccines carry risk, some vaccines carry a lot more risk than others. In the case of the vaccines for children program, the cumulative risk of the entire expanding vaccine schedule on our children has never been rigorously assessed.
So, let’s get back to assessing the benefits and risks of the smallpox vaccine as a case study.
From the CDC website, today:
“The smallpox vaccine is safe, and it is effective at preventing smallpox disease.”
Let’s see what safe means to the CDC, from their own website:
Serious Side Effects of Smallpox Vaccine
· Heart problems
· Swelling of the brain or spinal cord
· Severe skin diseases
· Spreading the virus to other parts of the body or to another person
· Severe allergic reaction after vaccination
· Accidental infection of the eye (which may cause swelling of the cornea causing watery painful eyes and blurred vision, scarring of the cornea, and blindness)
The CDC then lists the types of people who might have reason to not take the smallpox vaccine...
The risks for serious smallpox vaccine side effects are greater for:
· People with any three of the following risk factors for heart disease: high blood pressure, high cholesterol, diabetes, high blood sugar, a family history of heart problems, or smoking
Let’s take a break here and look at just the first four items, the people described as being at greater risk of serious smallpox vaccine side effects:
· People with diabetes – that’s 34 million Americans;
· people with high blood pressure (108 million Americans);
· people with high cholesterol (76 million Americans);
· people with heart disease (96 million Americans)
And there’s more:
· People with heart or blood vessel problems, including angina, previous heart attack, artery disease, congestive heart failure, stroke, or other cardiac problems
· People with skin problems, such as eczema [31 million Americans], atopic dermatitis, burns, impetigo, contact dermatitis, chickenpox [more than 95% of American adults have had chicken pox], shingles, psoriasis, or uncontrolled acne
· Infants less than 1 year of age
· Women who are pregnant or breastfeeding
· People who are taking steroid eye drops or ointment
So, while the CDC definitively states that “The smallpox vaccine is safe,” they then exclude huge segments of the population, leaving very few people for whom it might be safe. The list of people at greater risk also includes people with a “family history of heart problems.” Do any of us know even a single person who doesn’t fit that into that category?
The CDC writes that “for every 1,000 people vaccinated, 1 person experienced a serious but not life-threatening reactions. These reactions may require medical attention” The CDC estimates that “1 to 2 people out of every 1 million people vaccinated could die as a result of life-threatening reactions to the vaccine”
However, other researchers place the risks as higher.
A 2021 study assessing vaccine risks in the military population who have received the more modern, smallpox vaccines reported the following.
897,227 SM who received ACAM2000 smallpox vaccine and 450,000 SM who received Dryvax smallpox vaccine were included in the surveillance population. The rate of adjudicated (proven) myopericarditis among ACAM2000 smallpox vaccine recipients was 20.06/100,000 and was significantly higher for males (21.8/100,000) than females (8.5/100,000) and for those < 40 years of age (21.1/100,000) than for those 40 years or older (6.3/100,000). Overall rates for any cardiovascular event (Group 1 plus Group 2) were 113.5/100,000 for ACAM2000 vaccine and 439.3/100,000 for Dryvax vaccine; rate ratio, 0.26 (95% CI, 0.24-0.28). The rates of subjects with one or more defined neurological events were 2.12/100,000 and 1.11/100,000 for ACAM2000 and Dryvax vaccines respectively; rate ratio, 1.91 (95% CI, 0.71-5.10).
The study above is based off of a passive data reporting system, not a clinical trial - so the actual numbers of adverse events are much higher than reported here.
So, cardiac events associated with the smallpox vaccines were at least 1 in every 885 people for the ACAM2000 vaccine and one in every 228 people for Dryvax vaccine in a healthy population. These risks seem highly significant to me, given that the risk of small pox is nil at this time (unless the military knows something that we don’t). Which is why the push to vaccinate all first responders against Smallpox during the Cheney administration (otherwise known as POTUS #43 George W. Bush) was halted - because of
1. too many cases of myopericarditis and
2. no circulating Smallpox.
Sound familiar?
The term safe obviously means different things to different scientists and differing cohorts of people.
Note: The Mayo Clinic disagrees with the CDC on the risk and benefits of the smallpox vaccine:
“No cure or treatment for smallpox exists. A vaccine can prevent smallpox, but the risk of the vaccine's side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.”
Too high for patients of the Mayo Clinic – but no too high for Americans advised by the CDC. Although a note about the above quote, as 70% of people survive smallpox, it sure seems like they are “cured.” As for treatments, we no longer live in the middle ages - supportive care for infectious diseases work and are highly effective. Words matter - fearporn is not helpful.
To bring this topic home: Is avoiding COVID-19/Omicron worth taking the known and unknown risks of serious adverse events? In some age categories, it might be. In most age categories, it is not worth much risk. For young people, it is not worth any risk, and for children, the risks of the Covid vaccine far outweigh the risks of Covid.
The US Government had relentlessly promoted that “The vaccines are safe and effective,” the same words used for the modern smallpox vaccine. In both cases, safety is a matter of opinion and semantics – not science. Clearly, safety is relative, such as the precautions one might take when skydiving or riding a motorcycle (e.g., having a second parachute, wearing a helmet) – in order to reach the point that an activity is acceptably safe, all the while knowing it’s safer to just skip the activity.
If I proposed a person drink some potion, and said “This potion is safe, unless you are from a family with a history of heart problems,” few people would want the drink. If I added “Oh yeah, and the Mayo Clinic says the risk of side effects from this potion are too high to justify you drinking it, I’d have even fewer takers.
Mandates, which are rigid by definition, seem a bad match for assessments of personal safety, which are, by our nature, flexible and variable. Since the word safe and the idea of safety means different things to different people, such decisions are best left to those who would be most affected by, in this case, vaccination.
The smallpox vaccine shows us what the CDC means when they say something is “safe,” and it isn’t what most people using the word would mean. With risk must come choice. This is the bedrock foundation of modern bioethics and medicine.
After all that we have been through over the last two years, and the admission the the CDC has been withholding data from all of us for political reasons and to avoid “vaccine hesitancy” (which is another way of saying if you knew what the data really show you would not accept the product), who are you going to trust? Your own lying eyes and brain, or what the CDC, HHS, legacy media and the “factchecking” industry tell you?