The placebo group is an important part of every medical trial. With a placebo group, or control group, we are able to see if the intervention (in this case, the shot) is safe and effective. If there are more deaths in the group receiving the experiment than in the control group, then we know that the experiment is unsafe and should be halted. Also, if the experiment group has less breakthrough infections and less hospitalizations, then we have data to show that it truly is effective.
Arguably, the control group should be unaware that they are in the control group–and they should remain in the control group through the duration of the trial. If the people who received the placebo are told that they are experiment-free and then rush out to get the experiment, the medical trial is then over. Without a control group, we have no ability to see the pros and cons of the shot and no ability to truly tell the world that they are vetted and safe. Long-term testing plays an important role in our ability to declare a medical intervention “safe and effective.”
In the case of the COVID-19 shots, there has been no such long-term testing, and there is no longer a control group. As soon as the jabs got emergency use approval from the FDA, the manufacturers actively promoted vaccination to the placebo group.
Scientists are Concerned
Dr. Steven Goodman, a clinical trials specialist at Stanford, said:
“We don’t know how long protections lasts,” he says. “We don’t know efficacy against variants — for which we definitely need a good control arm — and we also don’t know if there are any differences in any of these parameters by age or race or infirmity.”
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In January 2021, the WHO published this in the New England Journal of Medicine:
Large, placebo-controlled, phase 3 efficacy trials could provide much of the needed information if they have appropriately prolonged follow-up while random assignments are still blinded. Such continuation would yield unbiased evidence on the duration of protection and on longer-term safety, including assessment of any evidence of the vaccine eventually enhancing the risk of severe disease (as was recently detected by continued follow-up of placebo recipients in dengue vaccine studies4). If there are hazards, they need to be identified; conversely, longer follow-up might reassuringly demonstrate continued protection with few or no adverse consequences, reducing vaccine hesitancy.
This opportunity to obtain reliable evidence about longer-term effects would be destroyed by early unblinding and immediate vaccination of participants assigned to placebo. Although each participant has the option to pursue any available intervention, if substantial numbers of participants choose not to do so, continuation of blinded follow-up in a population in which no licensed vaccine is being deployed could yield important and unexpected findings that would be difficult to obtain reliably any other way.
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Indeed, “the opportunity to obtain reliable evidence about longer-term effects” has been destroyed because these companies did choose to unblind the placebo participants.
Pfizer
Just three days after receiving Emergency Use Authorization, Pfizer sent a letter to the placebo group, stating:
“Healthcare workers will be the first to receive the vaccine (if placebo group). The vaccine will be offered to all other participants (non-healthcare workers) during Visit 4/Month 6…We hope to vaccinate all healthcare participants Wednesday and Thursday of this week.”
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Moderna
November 23, 2020, Moderna sent a letter stating the following:
“Our intention is to ensure that all participants ultimately have the option of receiving the vaccine.”
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Four days before receiving emergency use authorization, December 14, 2020, Moderna sent this in a follow-up letter:
“If you would like to know whether you have received the mRNA-1273 vaccine or placebo, then you will be offered the opportunity to be unblinded…If you find out that you received the placebo, we plan to offer you the opportunity to receive the mRNA-1273 vaccine and to continue to be followed in the study. We hope to start offering the vaccine within approximately 1-2 weeks after EUA is granted for mRNA-1273.”
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Johnson & Johnson
“Once the upcoming protocol amendment is approved, we will be able to unblind all of our research subjects, and we will be offering the investigational vaccine to subjects who were randomly assigned to the placebo group.”
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Petition to the FDA
Over a year ago, ICAN submitted a Citizen Petition to the FDA on June 17, 2020 requesting that all Phase II and III COVID-19 vaccine trials include a placebo control group, that the placebo should be a saline injection without anything added, and that the placebo control group be at least equivalent in size to the experimental group.
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You can read the full Citizen Petition here.
While it’s good that the FDA agreed that there should be a placebo group in the vaccine trials, they did not enforce it.
The worst part is that, despite this open defiance of the FDA’s wishes and what is best to protect the American public and assure the safety and efficacy of the clinical trials, as far as we can tell, the FDA has done nothing to punish the companies for this open rebellion against the FDA’s guidance.
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Because of this outright defiance, ICAN has asked that the FDA require at least two years of data from these experiments before giving full approval.
The FDA should, at the least, not reward these companies for defying it by still licensing any of these
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vaccines based on a mere 6 months’ worth of data. It should demand at least two years’ worth of
data, especially because of the lack of placebo groups, before even considering granting licensure.
We will see if the FDA has a backbone and will stand up to these billionaire companies who seem to have a lot of power.