Remember when anti-vaccine folks used to say that there were no double-blind, placebo-controlled randomized clinical trials for vaccines?
What happened once they realized that there actually were?
They moved the goal posts…
Where are the Saline Placebos?
Okay, they said.
So you have done double-blind, placebo-controlled randomized clinical trials when testing vaccines, but what placebo did you use?
Was it a pure saline placebo?
“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
Although no guidelines actually call for using a pure saline placebo, that’s all anti-vaccine folks will accept these days.
That’s there MO – or method of operation.
They move the goalposts.
It doesn’t matter that there are often ethical and logistical problems with using pure saline placebos, that’s all they want to hear about it.
That they wouldn’t be satisfied and start vaccinating their kids if all vaccine studies started to use saline placebos should be evident when you consider that many vaccine studies have already used saline placebos!
- Year-round influenza immunisation during pregnancy in Nepal: a phase 4, randomised, placebo-controlled trial – “The control group will be placebo (saline injection). The justification for the use of a placebo injection in this trial is as follows: There is only one trial (Bangladesh) that demonstrates efficacy of influenza vaccination in pregnancy on perinatal outcomes and respiratory morbidity in early infancy. One of the issues with that study is that it was not placebo controlled. The “control” in that study was adult pneumococcal vaccine. It could be that the Bangladesh study underestimated the impact of influenza vaccine because the mothers and infants receive some indirect protection from the pneumococcal vaccine. In addition, influenza vaccine is not part of national policy or recommendations in Nepal at the current time and Ministry of Health officials are very interested in the results of our study as they consider their immunization program expansion over the next few years.”
- Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (FluBlok) against influenza in healthy adults: a randomized, placebo-controlled trial.
- Meningococcal serogroup B-specific responses after vaccination with bivalent rLP2086: 4 year follow-up of a randomised, single-blind, placebo-controlled, phase 2 trial.
- Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18-45.
- Immunogenicity, safety, and tolerability of the measles-vectored chikungunya virus vaccine MV-CHIK: a double-blind, randomised, placebo-controlled and active-controlled phase 2 trial.
But how do you know that they used a real saline placebo and not some kind of saline solution with other stuff in it?
If it isn’t clear to you in the methods section of the study, go to the source – the original clinical trials record and it will be listed there.
What are you going to be worried about now?
More on Saline Placebos
- VAXOPEDIA – Where are the Double Blind Placebo Controlled Randomized Trials about Vaccines
- VAXOPEDIA – Vaccine Testing and Development Timeline and Myths
- VAXOPEDIA – Ethics and Vaccines
- VAXOPEDIA – Why Aren’t Vaccines Regulated like Drugs?
- VAXOPEDIA – Anti-Vaccine Points Refuted A Thousand Times
- The ethics of placebo use in vaccine trials
- The brouhaha around placebo choice in vaccine trials
- Was the Gardasil vaccine ever compared with a placebo?
- There are no vaccine studies with saline placebo?
- 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
- Ebola vaccine trials raise ethical issues
- Answering human papillomavirus vaccine concerns; a matter of science and time
- Nine Questions, Nine Answers.
- The opposite of stumped: 9 unanswerable anti-vax questions answered
- Debunking myths about vaccine testing and safety
- Vaccine Development, Testing, and Regulation
- Vaccines aren’t tested – myth vs. science
- More Gardasil fear mongering: A “critical review” of HPV vaccination that lacks critical thinking
- Is the use of “Open-Label” Placebo Ethical in the Treatment of Children?