Have you ever heard that there are no double-blind, placebo-controlled randomized clinical trials for vaccines?
It isn’t true.
There are many double-blind, placebo-controlled randomized clinical trials that involved:
- flu shots
- pneumonia shots
- HPV vaccines
- potential HIV vaccines
- malaria vaccines
- rotavirus vaccines
- Dengue vaccine
- Staphylococcus aureus vaccine
That’s good, because double-blind, placebo-controlled randomized clinical trials are considered the “gold standard” when you do medical research.
“Placebo Control – A comparator in a vaccine trial that does not include the antigen under study. In studies of monovalent vaccines this may be an inert placebo (e.g. saline solution or the vehicle of the vaccine), or an antigenically different vaccine. In combined vaccines, this may be a control arm in which the component of the vaccine being studied is lacking.”
WHO on the Guidelines on clinical evaluation of vaccines: regulatory expectations
But do they all use a saline placebo?
No, not always, which typically leads anti-vaccine types to dismiss them outright and push anti-vaccine misinformation, including that they are never done.
It seems that they aren’t worried so much about the antigens in vaccines anymore (the Too Many, Too Soon argument), but are now more concerned about other vaccine ingredients. They will only be satisfied with a saline placebo, but they must miss the part about wanting the trial to be double-blinded, which gets harder to do if the placebo doesn’t look and “feel” like the vaccine.
And they miss the part that “not always” doesn’t mean never.
Gardasil is a good, recent example of a vaccine that had a double-blind, placebo-controlled (using a saline solution without an adjuvant) trial for safety.
Others vaccine trials use a saline control too, including efficacy and safety trials for a new recombinant, live, attenuated, tetravalent dengue vaccine (it worked and had a good safety profile), a malaria vaccine (a phase I dose escalation study), a universal flu vaccine, a Staphylococcus aureus vaccine, etc.
The Ethics of Placebo Use in Vaccine Trials
So why haven’t placebo control studies been done even more routinely then?
Why isn’t every vaccine on the immunization schedule or every combination of vaccines tested using a double-blind, placebo controlled study?
“Placebo use in vaccine trials is clearly acceptable when (a) no efficacious and safe vaccine exists and (b) the vaccine under consideration is intended to benefit the population in which the vaccine is to be tested.”
Placebo use in vaccine trials: Recommendations of a WHO expert panel
Of course, the answer is that in order to do this type of study, you would have to have a very good justification for leaving many of the kids unprotected and at risk for a vaccine-preventable disease.
Instead, as is discussed in the article “Current topics in research ethics in vaccine studies,” if a vaccine is “already in use in some other country or community which is more or less comparable to site where the trial is planned, that vaccine should be used as the comparator.”
So instead of a placebo, it is more common “to give another vaccine that provides comparable benefit against another disease, or more willingly, against similar disease caused by different agents.”
When can you use a placebo control?
The article states that “placebo controls are ethically acceptable when there is no proven vaccine for the indication for which the candidate vaccine is to be tested.”
But get educated and don’t be fooled, many double-blind, placebo-controlled randomized clinical trials have been done with vaccines.
What to Know About Placebo Use in Vaccine Trials
When it is ethical to do so, placebos have been used in vaccine trials, even saline placebos.
More on Placebo Use in Vaccine Trials
- Placebo use in vaccine trials: Recommendations of a WHO expert panel
- Report – Current topics in research ethics in vaccine studies
- WHO – Guidelines on clinical evaluation of vaccines: regulatory expectations
- WHO – Ethical considerations arising from vaccine trials conducted in paediatric populations with high disease burden in developing countries
- Was the Gardasil vaccine ever compared with a placebo?
- Nine Questions, Nine Answers.
- The opposite of stumped: 9 unanswerable anti-vax questions answered
- Debunking myths about vaccine testing and safety
- Study – Efficacy of 23-valent pneumococcal vaccine in preventing pneumonia and improving survival in nursing home residents: double blind, randomised and placebo controlled trial
- Study – Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.
- Study – Randomized, placebo-controlled trial to assess the safety and immunogenicity of an adenovirus type 35-based circumsporozoite malaria vaccine in healthy adults
- Vaccine Development, Testing, and Regulation
- Vaccines aren’t tested – myth vs. science
- Vaccinated vs. Unvaccinated Part 1 – An RCT Overview
So…how about some links to all of these double-blind flu vaccine trials? It’s also dishonest to try to lump the influenza shots in with the actual real diseases like polio, smallpox, etc.
Maybe a better question would be, ‘what are the goals of biomedical engineering industry to continue to force profits via vaccine for low risk disease, while creating more disease with vaccine adverse reactions and auto-immune disease?’
Janine, first PROVE everything you just said with credible sources. Second, you do realize that a lot of countries do not charge for medical care so what excuse do you use for those countries?
Just because a vaccine is “free” doesn’t mean that pharmaceutical companies don’t still get paid and profit from every single vaccine sold. Come on, you can’t be that dense!?! The costs per vaccine may not come directly from the recipients of the vaccine but rather may be funded or subsidized by taxes acrued by residents of citizens of that nation who has tax payer funded universal health care. Pharmaceutical companies are still being compensated and therefore PROFITING from every single vaccine sold whether they’re purchased by state government health agencies , hospitals or individua!s. Think critically please. dig a little deeper than believing just because a vaccine is provided at no direct cost to recipient ddlesnt mean pharmaceutical companies are altruistic and making vaccines with zero profit incentives…this comment is ridiculous and asinine. Guessing you get your flu shot every year!?
If a country is using a “free” universal health care model then that means the country’s public funds are paying the medical providers and pharmaceutical companies for the products and services used. The companies making vaccines are certainly getting paid for what they manufacture whether it is private or public insurance or private citizens paying for it.
Don’t hold your breath
carolynmonroe
Conspiracy tripe
Skeptic PAID Shill & it’s called Reality. You must work for this SHILL website considering the cognitive dissonance you’re suffering.
You wrote and I quote: “They will only be satisfied with a saline placebo, but they must miss the part about wanting the trial to be double-blinded, which gets harder to do if the placebo doesn’t look and “feel” like the vaccine.” What are the differences between a saline injection and let’s say, an aluminum hydroxide solution injection, that make the first one not “feel” like a vaccine?
Many anti-vaxers just want the option to opt out of the vaccines. How is that evil?
If you don’t understand why we can help you
If you’re going to forcibly compel a parent to inject various chemical and biological compounds into their brand new healthy baby and leave them as the sole source of responsibility if that child has an adverse even as a result, than you better provide some research showing each individual component is safe and has a both short and long term studies backing their efficacy and safety. As of right now vaccine adjuvants have been shown to be neurotoxic and have the potential to invoke life long side effects and adverse reactions. There are few studies that dispute this. Further more, the manufacturers have legal immunity and cannot be held responsible for the adverse events that occur , leaving the parents to pick up the pieces of their permanently injured children, some of whom will never be able to take care of themselves and require round the clock care for the rest of their lives. This is why antivaxxers want the studies to be done with saline vs aluminum hydroxide . Furthermore, some of the vaccines are not effective at all. Take the dtap. The pertussis component of the vaccine does not stop pertussis, it allows the vaccine recipient to become a carrier . Majority of pertussis cases happen in vaccinated individuals. Check the CDC website, it is stated clearly in their charts and breakdowns of pertussis cases.
carolynmonroe
Everything you have just stated is false or a complete distortion of the facts
Because you named you “Truth” it doesn’t mean it is on your side. And when you say “everything you stated is false” it also doesn’t mean that it is.
You said “everything” is false or a distortion and then provide literally no evidence or sources for your claim. This is the problem we anti-vaxxers have with you guys. You almost never provide evidence. The majority of Anti-Vaxxers have spent years of our lives studying these things because we want to make well-informed decisions regarding the medical care we give our children. All you have to do is persuade us by facts and logic, but that case has yet to be made.
Maybe a saline injection doesn’t feel like a vaccine. So what, shouldn’t we make safety studies at all? Either everything or nothing? An adjuvant placebo is nothing, because the adjuvant is the one under question.
And how is an adjuvant placebo more ethical than a saline?
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