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Pfizer Inc. and BioNTech SE may soon allow participants in its Covid-19 vaccine trial to learn whether they received a placebo, rather than the real thing, and get the actual shot if they wish.
“Pending required approvals, Pfizer and BioNTech plan to provide an option for clinical trial participants who received the placebo to get the vaccine at scheduled time points in the study,” Pfizer said in an emailed statement. “This option will be voluntary and implemented in alignment with the regulatory authorities where the trial is being conducted.”
The Food and Drug Administration, which oversees human trials of new drugs and vaccines, didn’t immediately comment.
Regulators and ethicists have debated for months over whether to keep participants blind to what they received or to give all trial volunteers the vaccine, which was found to protect people against the deadly virus. Placebo groups are important for comparisons, and giving everyone in the trial the vaccine may reduce the possibility of identifying long-term side effects.
John Vanchiere, who leads a trial site at Louisiana State University Health Shreveport, said he plans to email the 245 people who participated in the trial through the center to give them instructions pending a final decision on unblinding the trial.
Allowing participants who received a placebo to now take the vaccine itself might also hold implications for other vaccine developers, including Moderna Inc., which could receive emergency use authorization for its Covid-19 experimental vaccine as soon as this week.
A go-ahead may allow some 19,000 people who received placebos to get Pfizer’s shot, which is in short supply. Pfizer’s emergency use application provided data from 37,586 volunteers, the majority of whom were in the U.S., according to the FDA. Of those, 18,785 people received a saline placebo.
Vanchiere said he has vials of Pfizer’s vaccine stored in an ultra-cold freezer and could start administering the shots as soon as Monday, the same day the vaccine is expected to start being offered to health-care workers.
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