Experts Say It Is Ethical To Offer Vaccines To Former Placebo Study Participants
The Claim
The medical community violated scientific integrity by offering vaccines to individuals who had originally received placebos during clinical trials.
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Emerging story
In recent days, a number of articles and social media users have been criticizing the organizers of coronavirus vaccine trials for “unblinding” trial participants by offering vaccines to those who had been given placebos. Those criticizing this decision state that it is a violation of scientific integrity to offer vaccines to placebo control groups, as it hinders long-term studies of the vaccines’ efficacy.
Misbar’s Analysis
Many medical experts agree that offering vaccines to the studies’ placebo participants is ethical. Some sources have also highlighted that, ultimately, it is impossible to prevent participants from leaving the study to vaccinate themselves. Both of these opinions are expressed in an article that appeared in the Journal of the American Medical Association, which states that the risks to the placebo participants were too great to justify continued participation in the trials after emergency use authorization. It also states that participants, “could simply withdraw from the study and seek vaccination outside the trial.”
An expert working group within the World Health Organization came to a similar conclusion, that current research-ethics guidance documents did not consider emergency use deployment. Overall, they concluded that the ethical imperative of offering vaccines to placebo patients outweighs the scientific imperative, especially among participants who are at a high risk of significant harm from coronavirus. For participants who were not high risk, the group said that placebo participants should be informed of the scientific advantage of remaining in the trial but also informed of their right to withdraw.
Dr. Tal Zaks, the chief medical officer of Moderna, agrees with giving placebo participants vaccines. He stated that his company had an ethical obligation to allow the placebo group to access the vaccine as soon as it was approved. The CEO of Pfizer has also said that his company is morally obligated to offer placebo participants their vaccines.
A number of medical professionals who work for leading American medical schools have also made a similar conclusion. Frontiers in Public Health stated that withholding vaccines from placebo participants was both difficult and ethically fraught.
The majority of the articles that criticize the placebo group being offered the vaccine link back to an NPR article that provided this news. This article acknowledges that offering vaccines to the placebo group results in the potential loss of reliable long-term data. However, it also highlights that there are a number of other solutions to tracking the long-term effectiveness of the coronavirus vaccines, such as identifying people in groups who are not eligible for a vaccine as a control group.
