Site icon VAXOPEDIA

The Saline Placebo Pyramid

Vincent Iannelli, MD

The Saline Placebo Pyramid helps show that many vaccines use a saline placebo, something that might be a concern if you listen to anti-vaccine propaganda.

Our Saline Placebo Pyramid helps show that many vaccines did indeed use a saline placebo when they were studied.

It refutes the Placebo Pyramid Scheme that anti-vaccine influencers have been pushing…

The Saline Placebo Pyramid

Why a pyramid?

Because there are a lot of individual vaccines that were tested with a saline placebo!

They form the base of the pyramid.

Newer vaccines and combo vaccines that came later were then tested using these vaccines as a control group, as it is unethical to give someone a saline placebo and leave them at risk to get a disease when a vaccine already exists.

Vaccines that were studied with saline placebos include:

You probably didn’t think that there were that many vaccines that were studied with a saline placebo, did you?

Vaccines Studied Without Saline Placebos

It is true that we started to use some vaccines that didn’t use saline as a control in their original clinical trials.

How come?

“Diphtheria and tetanus toxoids came into general use without field trials; first, because the concept had not been formed, and second, because antitoxin measurements and Schick tests were considered unique measurements of immunity to infection.”

Effects of Routine Immunization of Children with Triple Vaccine (Diphtheria-Tetanus-Pertussis)

Remember, the original diphtheria and tetanus vaccines were first discovered nearly one hundred years ago!

Still, we know that they are safe and effective. These vaccines have been in hundreds of clinical trials!

In fact, a Td vaccine was studied using only the diphtheria and tetanus antigens, with an alum adjuvant, as a control.

“No noteworthy reaction” was seen in either the Td vaccine (with the alum adjuvant) or a fluid diphtheria-tetanus preparation, which was also being studied.

Now if either the Td antigens or the aluminum adjuvant were causing side effects, why weren’t they seen in this study? Why wasn’t there a difference between the three groups of folks in the study?

The chicken pox vaccine also didn’t use a saline control.

Thirty-eight kids who got the placebo ended up getting chicken pox in this trial.

It used a control that “contained no viral material” though.

It consisted “of lyophilized stabilizer containing approximately 45 mg of neomycin per milliliter” and the trial found the vaccine to be safe and effective.

The placebo in the Salk vaccine trial was Mixture 199 and included antibiotics, formalin, red coloring, and a buffer – so basically it was the vaccine without any of the polio virus.

The placebo in the hepatitis B vaccine trials was alum in the vaccine diluent.

With the hepatitis A vaccine, they used an aluminum hydroxide diluent, which also contained a very small amount of thimerosal.

Vaccines Studied with Saline Placebos

Now let’s take a look at all of the studies of vaccines with saline placebos.

The acellular pertussis vaccine was studied with a saline placebo.

“In a randomized observer- and subject-blinded study, adults (r18 years of age) received an acellular pertussis (aP) vaccine containing genetically inactivated pertussis toxin (PT), Ælamentous hemagglutinin (FHA) and pertactin (PRN), or a saline placebo, and were monitored for safety and immunogenicity.”

An acellular pertussis vaccine in healthy adults: safety and immunogenicity. Pennridge Pediatric Associates

The study found the vaccine to be “safe and immunogenic.”

While not saline or salt water, the oral polio vaccine (Sabin vaccine) was studied against a cherry-flavoured, sucrose solution” or sugar water.

Similarly, an oral typhoid vaccine used “a milk powder and sugar solution” as a placebo.

The Hib vaccine was studied with a saline placebo.

“We randomly assigned subjects to receive vaccine from one of five investigational lots of PRP-D (800,10 of subjects) or to receive saline placebo (200,10 of subjects).”

Safety and immunogenicity of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine (PRP-D) in infants

And they found that the Hib vaccine was safe and immunogenic and that “there was no difference in the reactions of vaccinees and of placebo recipients.”

The measles vaccine was studied with a saline placebo.

“Physiological saline was used as placebo for inoculation of the children in the control group.”

A comparative study of two live measles vaccines in Iran

What did they find?

“There was, on the other hand, the same range of temperature for the same percentage of controls. The pyrexia of the control group, as well as coryza, cough and diarrhoea, was due to respiratory infection that was endemic in the area at the time of the study.”

A comparative study of two live measles vaccines in Iran

These measles vaccines were safe and effective.

And yes, the Edmonston B strain measles vaccine was also tested using a saline placebo.

The rubella vaccine was studied with a saline placebo.

“Two of these groups had been designated to receive a saline placebo, while each of the remaining three was to receive one of the vaccines being studied.”

Comparative Studies of Rubella Vaccines

What did they find?

“There were no significant adverse reactions immediately after the vaccination of immune or susceptible children in either trial. Transient, mild joint symptoms were associated with the administration of HPV-77DK13 to susceptible children in the DeKalb County trial.”

The RA 27/3 strain rubella virus vaccine was also studied with a saline placebo.

The mumps vaccine was studied with a saline placebo.

“Accordingly, on Nov. 11 and 12, 1966, teams of physicians, nurses, and clerical workers visited each of 44 Forsyth County elementary schools, at which time 0.5 c.c. of mumps vaccine or sterile isotonic saline was administered subcutaneously in a single dose to the children previously selected for inclusion in the study.”

Field evaluation of live virus mumps vaccine

What did they find?

“No significant difference between the two groups in the reporting of any of the symptoms elicited from the parents could be discerned. Neither was there any difference in the day or days in which a particular symptom occurred. In particular there was no excess of local reactions, fever, or mumps in the vaccinated children.”

Field evaluation of live virus mumps vaccine

Oh, and the “efficacy of the vaccine in protecting against mumps was calculated to be 95.6 per cent!”

The BCG vaccine was studied with a saline placebo.

“One group (about 20% of the study population) was given a placebo (saline).”

Epidemiologial significance of the local reaction to direct BCG vaccination

The study found “that when BCG vaccination is given without previous tuberculin testing no excessive reactions are seen in the persons who have tuberculin sensitivity before vaccination.”

The original Prevnar vaccine was studied using a saline placebo.

“The placebo administered at the initial visit was 0.9% saline and was visually indistinguishable from the vaccines.”

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Prime-Boost Strategy for Pneumococcal Vaccination in Adult Liver Transplant Recipients

The study was in adults, but still, it used a saline placebo and found no safety issues with Prevnar.

And these other pneumococcal vaccines listed above were also studied with saline placebos.

The HPV vaccine was studied with a saline placebo.

Sure, not everyone in the clinical trials got saline, but some did.

The flu vaccines have been studied with a saline placebo.

“Subjects were randomized to 1 of 4 regimens in year 1:
2 doses LAIV, 1 dose LAIV, excipient placebo, or saline placebo.”

Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children

Not surprisingly, they found that 1 and 2 doses of the nasal spray flu vaccine were well tolerated and provided “clinically significant protection against influenza illness.”

You also shouldn’t be surprised to learn that flu shots have been also studied with saline placebos!

“The following preparations were used: commercial trivalent, inactivated split-virus influenza vaccine (Wyeth-Ayerst, Philadelphia), 1990-1991 formulation, containing 15 mcg each of hemagglutinin of A/Taiwan/1/86 (H1N1), A/Shanghai/16/89 (H3N2), and B/Yamagata/16/88 antigens (normal saline was used as the intramuscular placebo) and trivalent live attenuated, cold-adapted influenza vaccine (Odessa Production Company for Biological Products, Odessa, Ukraine), which was made by using the donor strains A/Leningrad/134/17/57 (H2N2) and B/ Leningrad/14/55.”

Comparison of US inactivated split-virus and Russian live attenuated, cold-adapted trivalent influenza vaccines in Russian schoolchildren

The study found that “adverse reactions to the vaccines were minimal.”

The cholera vaccine was studied with a saline placebo.

The dengue vaccine was also studied with a saline placebo.

Is that a big enough list to finally put to rest the myth that vaccines are not studied with saline placebos?

Vaccines Studied with Unvaccinated Control Groups

Surprisingly, instead of saline or another vaccine, some vaccines were studied using unvaccinated control groups.

This includes:

What did they find?

As expected, they found that the people who were unvaccinated in the trials got sick more often than those who were vaccinated!

What to Know About the the Saline Placebo Pyramid

Most vaccines have been studied with a saline placebo.

They can then serve as control vaccines in trials for newer vaccines, as we already know that they are safe and effective.

Continuing to use saline placebos when an alternative vaccine is available is considered unethical, as it leaves the person at risk to get sick, getting no benefit from the trial if they were to get a placebo.

Continuing to scare people and promote propaganda that vaccines are not studied with saline placebos is immoral.

More on Vaccines with Saline Placebos

Exit mobile version