Remember how some folks were calling for saline placebos in vaccine clinical trials?
What are they going to complain about now???
Many Covid-19 Vaccines Were Studied With Saline Placebos
No doubt they will find something, but next time you hear someone complain about placebos, you can let them know that most of the COVID-19 vaccines being developed do indeed use saline.
And they use saline placebos!
Is that important?
Well, it is important to have a placebo, but it doesn’t necessarily have to be saline.
“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
So then why did so many vaccine manufacturers opt to use a saline control?
Well, you might get some idea when you look at the ingredients of the COVID-19 vaccines…
“The Pfizer-BioNTech COVID-19 Vaccine is a white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection. The vaccine contains a nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2. The vaccine also includes the following ingredients: lipids ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine, and cholesterol), potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose.”FDA Briefing Document Pfizer-BioNTech COVID-19 Vaccine
While most vaccines contain far fewer ingredients than you might imagine, the COVID-19 vaccines don’t include an adjuvant, preservative, or much or anything else.
That likely made using a saline placebo an easy choice.
And using a saline placebo helps illustrate that many of the events that happen in the clinical trials for a vaccine have absolutely nothing to do with the vaccine.
Like the deaths in the folks who got saline, the two deaths in the vaccine group in these clinical trials had nothing to do with the vaccine.
“A total of six (2 vaccine, 4 placebo) of 43,448 enrolled participants (0.01%) died during the reporting period from April 29, 2020 (first participant, first visit) to November 14, 2020 (cutoff date). Both vaccine recipients were >55 years of age; one experienced a cardiac arrest 62 days after vaccination #2 and died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1. The placebo recipients died from myocardial infarction (n=1), hemorrhagic stroke (n=1) or unknown causes (n=2); three of the four deaths occurred in the older group (>55 years of age). All deaths represent events that occur in the general population of the age groups where they occurred, at a similar rate.”Pfizer-BioNTech COVID-19 Vaccine FDA Briefing Documents.
Although they might have more mild and moderate side effects than more commonly used vaccines, you can be assured that the COVID-19 vaccines that are being approved are safe and effective, and if it is important to you, know that many were studied with a saline placebo.
More on Vaccines and Saline Placebos
- Where Are the COVID-19 Package Inserts?
- The Truth About COVID-19 Vaccines
- Are Vaccines Only Tested for 4 or 5 Days?
- Reasons to Be Confident in a COVID-19 Vaccine
- COVID-19 Vaccine Challenges
- Would Most People Say No to a COVID-19 Vaccine?
- Where Are the Pediatric COVID-19 Vaccine Trials?
- FDA – Briefing Document Pfizer-BioNTech COVID-19 Vaccine
- Placebos Used in Vaccine Trials Do Not Please Everyone
- Placebo-Controlled Trials of Covid-19 Vaccines — Why We Still Need Them
- 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?
- WHO – Guidelines on clinical evaluation of vaccines: regulatory expectations
- Safety and immunogenicity of the Ad26.COV2.S COVID-19 vaccine candidate: interim results of a phase 1/2a, double-blind, randomized, placebo-controlled trial
- First-in-Human Trial of a SARS CoV 2 Recombinant Spike Protein Nanoparticle Vaccine
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