Coronavirus Vaccine: Why It’s Important to Know What’s in the Placebo

Coronavirus Vaccine: Why It’s Important to Know What’s in the Placebo

Some researchers conducting clinical trials on a COVID-19 vaccine have not revealed to the public what the placebo contains, but they should. This is because the placebo ingredients influence how effective or harmful the active treatment, with which the placebo is compared, appears. Our new guideline published in PLOS Medicine remedies this problem by providing a template for reporting what’s in placebo controls.

In some COVID-19 vaccine trials, participants in the control group (the group receiving a placebo) are injected with a saline solution. In other trials, they receive an actual treatment. For example, in the COVID-19 vaccine developed by the University of Oxford, the control group receives a meningitis and septicaemia vaccine as a placebo.

The benefit of using an actual vaccine as the placebo control is that it will cause a similar reaction at the site of the injection as the COVID-19 vaccine, such as muscle pain and soreness. This prevents patients from knowing whether they are getting the placebo or the real treatment. The scientific term for hiding knowledge of who got what treatment is “blinding”.

If patients know they are getting the real thing, they may expect to get better, and their expectations can make them get better a bit faster. And if they know they are getting the placebo, they could drop out of the trial because they know they aren’t getting the actual treatment. Adding an actual vaccine to the placebo control helps the trial remain blinded and so prevents bias arising from differing expectations.

Active Placebos

The main problem with including something active in the placebo, such as another vaccine, is that it can confuse researchers when they measure side-effects.

We determine whether an active treatment has a particular side-effect, such as redness and swelling at the site where the needle went in, by comparing it with a placebo. In the same way that we conclude that an active treatment works if it is better than a placebo, we conclude that it is harmful if it has more side-effects than the placebo.

What researchers are looking for is a difference. So if the active vaccine causes more numbness at the site of injection than the placebo, you can reliably say that numbness is a side-effect of the active vaccine. But if the placebo is designed to cause the side-effect (like redness and swelling), then the normal way of detecting side-effects doesn’t work. Since the placebo causes the side-effect, we will no longer be able to detect a difference. In other words, the two side-effects, being the same, negate each other.

The problem is that we rarely know how to interpret side-effect information in trials because researchers rarely report what’s in placebo. Reporting placebo ingredientsspecifically in vaccine trials, is not common. This makes it difficult to tell what the true harms of the vaccine are. The same applies to most treatments tested in trials with unknown placebos.

Placebo controls are rightly the gold standard against which new treatments are measured. If a new treatment proves to be better than a placebo, it is taken to be effective. Otherwise, it isn’t. The problem is that until today, there has been no standard for placebos, which made estimates of side-effects confusing. Our new guideline fixes this problem by encouraging rigorous reporting of placebo ingredients.

We’ve known about the failure–and need–to report what’s in placebos for 15 years. By following the new guideline, we can get more accurate information about how beneficial and harmful treatments tested in placebo-controlled trials are.


This article was reprinted with permission. It was originally published in The Conversation.

Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers.  The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.

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3 Responses to "Coronavirus Vaccine: Why It’s Important to Know What’s in the Placebo"

  1. Colorado   October 5, 2020 at 5:07 pm

    The whole premise of their placebo approach rests on the presumption that those supposedly minimal effects known from other vaccinations are a non issue.

    Every presumption theory and hypothesis which rests on that point will result in flawed studies down the line. Every vaccine is harmful to the body. The only true baseline for vaccination vs not is a truly non vaccinated person or water shot.

    To understand the science of vaccines, is to understand their harm to the body. They need those irritants in there because your bodies natural immediate response to injected toxins is to flush it out as quickly as possible. Who thinks forcing your body to deal with more toxins, rather than less, results in better health.

    Every quasi quack scientist on the planet working with vaccines is just that, a total and complete fraud. Vaccines hail from the days of snake oil, it’s just another quack science that humanity would be better off without.

    Reply
  2. Mark   October 5, 2020 at 7:02 pm

    “By following the new guideline, we can get more accurate information about how beneficial and harmful treatments tested in placebo-controlled trials are”. This is precisely what the vaccine industry does not want. It is what the allopathic medicine does not want. It is what the Emperor does not want us to see. This is not about science. It never was about science. It is about selling a product with wishful thinking, salesmanship, and billions of dollars in return if their hucksterism pays off.

    Reply
  3. Karen   October 6, 2020 at 9:21 am

    Oftentimes a placebo these days isn’t a true placebo, it’s another vaccine used as a placebo.

    Reply

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