Among the many rumors and false information circulating about vaccines against Covid-19, one of them suggests that some people have received, without their knowledge, injections of a placebo solution without any effect, instead of the vaccine. It is correct that several volunteers received a dose of placebo as part of the clinical trials of the vaccines. But rumors about this are often accompanied by theories of a global conspiracy, such as the idea that those vaccinated are “guinea pigs” or that placebos are administered to part of the population during the general vaccination campaign. in order to cover up the harmful effects of anti-Covid vaccines.
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On social networks or in secure messengers like Telegram, publications claim that part of the population received not a dose of vaccine but a placebo solution, some even claiming that “30% of Covid-19 vaccines are placebos“.
Via the Faky anti-disinformation platform, a surfer also asks us about a rumor that would come from a doctor and who would like, “during the anti-Covid vaccination campaign, some had received a placebo instead of the vaccine, supposedly to assess the side effects of the vaccine“.
As part of a clinical trial, a placebo is a product without active effect. It is used in comparison with the substance whose effectiveness we want to measure.
The “phase three” trials
One of these ideas is rooted in the fact that vaccines, such as those marketed by Pfizer / BioNTech or Moderna, are still in “phase three” of their development. It is correct that the phase three studies will end on May 2, 2023 for that of Pfizer and the October 27, 2022 for that of Moderna.
Some images are circulating on social networks to support the fact that placebos are given instead of vaccines. The information in the image below is correct, but the use of placebo is only for clinical trials with volunteers.
This incomprehension ties in with the conception according to which the vaccinated persons would therefore be “guinea pigs”, subjected to a product still in full experimentation. As Faky explained in a previous article, such a statement is misleading. In the exceptional context of the production of vaccines against Covid-19, the fact that the phase 3 trials have not been completed is in no way a sign that the products administered are not reliable.
As recalled the professor in immunology at ULB, Eric Muraille: “The Covid-19 vaccines used in Europe have successfully passed phase 1, 2 clinical studies and are more than a year away from phase 3. However, statistically, the vast majority of side effects resulting from administration of a vaccine are observed during the first six months“.
Differentiate between clinical trials and vaccination campaign
A distinction should be made here between clinical trials and vaccination campaigns. Phase three clinical trials are performed on a defined group of volunteers, and have the particular objective of determining its effectiveness by compared to a placebo.
“Within the groups, 50% of people receive the vaccine, and 50% receive a placebo. THEThose responsible for measuring, recording and evaluating changes in research participants do not know which participants received treatment and which received placebo. The selection is made by drawing lots, which is called a randomized study.“, Explain Jean-Michel Dogné, director of the pharmacy department of UNamur and expert at the WHO World Vaccine Safety Committee, at the FAMHP (Federal Agency for Medicines and Health Products) and at the European Medicines Agency (EMA).
The use of placebos is therefore restricted to these test groups; vaccination campaigns for the population are not concerned. “It should be understood that people who participate in studies do not receive a placebo without their knowledge, but are fully aware of the conditions of the study and sign an informed consent form. In addition, it would be impossible to carry out a follow-up similar to what is carried out in the study phases, for the entire population that would have received a vaccine.“, recalls Jean-Michel Dogné.
Vaccination for those who have participated in clinical trials
In the UK, the question of the vaccination status of people who received a placebo in a study was discussed in Parliament.
A statement by the Parliamentary Under-Secretary of State for the deployment of the Covid-19 vaccine aroused misunderstandings. Nadhim Zahawi declared on July 22, 2021 that people who received a placebo during the test phases “will be considered fully vaccinated regardless of whether they received the placebo or the vaccine“.
As clarified by the verification site Full Fact, in the United Kingdom, people who received a placebo are considered vaccinated, but only for the duration of the trials and for the following 16 weeks. Period after which they will be invited to be vaccinated. Contacted about this by the verification site, UK Department for Health and Welfare had explained this decision by the desire not to disadvantage those who would have received or would receive a placebo as part of the trials.
It should also be remembered that candidates who have participated in study phases can be vaccinated whenever they wish. “Each person can stop the study at any time and without any restrictions“, explains Jean-Michel Dogné. For the Pzifer, at the extent to which the vaccine is proven to be effective, study participants who received a placebo were offered a real vaccination anyway.
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This is what indicates the results of a study on the effectiveness of the Pfizer vaccine at six months, available online: “From December 2020, after BNT162b2 (Pzirer vaccine, editor’s note) became available under emergency or conditional use authorizations, participants aged 16 years or older who became eligible for vaccination against Covid-19 in accordance with national or local recommendations, were given the opportunity to to learn in which group they were. Those who were randomly assigned to receive a placebo were offered BNT162b2“.
So, although Phase 3 observations are still ongoing and will extend for two years for the Pfizer vaccine, “most of the participants who initially received a placebo have now been immunized with BNT162b2, thus ending the placebo-controlled period of the study“.
Physiological saline required to prepare the Pfizer vaccine
Theories claiming that part of the population is subjected to injections of a placebo without being warned, sometimes feed on very real situations.
In April 2021, several cases of errors were also reported in France. On April 3, 2021, a vaccination center in Hauts-de-Seine for example administered physiological saline instead of Pfizer vaccine to 54 people.
On April 15, a similar situation occurred in a vaccination center in Deauville, in Calvados. 180 people were then concerned. On April 20, 140 people received a dose of physiological serum, in Epernay, in the Grand Est.
In each of these situations, the errors were quickly noticed by the caregivers and the patients concerned were invited to make a new appointment to be, this time, really vaccinated. In cases where physiological serum was injected instead of the anti-Covid vaccine, it was also Pfizer’s Comirnaty that was concerned.
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The presence of physiological serum in vaccination centers This is because the latter is necessary for the preparation of the Pzifer / BioNTech vaccine, which must be reconstituted by caregivers. As Liberation also reminds us, Moderna’s vaccines, AstraZeneca and Johnson & Johnson do not require preparation.
In Belgium, the different steps required to prepare the Pfizer vaccine are carried out by one and the same person, as explained by Pierre-Louis Dedon, medical inspector of hygiene at Cocom and medical referent for the vaccination campaign of Brussels-Capital. “The person injects 1.8 ml of physiological saline into the vaccine vial, mixes gently and draws the sample with a syringe.“
How to explain these errors?
Errors could occur, as the Parisian explains, if the physiological saline injections are carried out in vaccine vials which would in fact be empty as a result of their use.
Another explanation could be mistakenly diluting a vial that has already been diluted beforehand, but according to the doctor, the margin of error is small: “Normally, the vials that have already been used are discarded, we can also identify them thanks to the mark left on the lid by the passage of the needle“.
There remains the possibility of intentional manipulation “that could have been done by an anti-vaccine person working in a center“, suggests Pierre-Louis Dedon.
This possibility is reminiscent of what happened in Germany a few months ago, where a nurse admitted to having administered saline to six patients instead of the vaccine. She first explained her gesture by claiming to have tried to cover up the fact that she would have dropped a vial of vaccine. The police officers in charge of the investigation subsequently noticed anti-vaccination publications shared on social networks by the nurse in question, who also refused to cooperate with the investigators following his arrest.
The suspicions were initially about half a dozen doses. Finally, it is 8557 patients passed by the vaccination center who were called to be vaccinated again, the authorities not knowing precisely who was concerned by these injections of doses of saline solution.
No placebos in vaccination campaigns
The use of placebos is a reality that concerns only clinical trials for vaccines carried out in groups of people who are volunteers and fully aware that they may have received a placebo. As trials and research progress, effective vaccination is offered to participants who have received a placebo. The test phases which are expected to last for several years are therefore to be distinguished from vaccination campaigns for the population.
Injections of physiological serum in vaccination centers in France have been reported and the people concerned have been called to be vaccinated. In Belgium, this type of error remains very unlikely, and no such problem has been reported to date.
Finally, ensuring the follow-up of the entire vaccinated population and of people who received a hypothetical placebo – as some theories suggest – would be very difficult to set up from a logistical point of view, and does not rely on any concrete evidence. .