Moderna to offer vaccine to placebo recipients
Decision sparks debate
Cambridge-based biotech company Moderna announced it will offer its coronavirus vaccine to participants in the placebo group of the trial, a move that has sparked an ethical debate.
Moderna announced earlier this week it will “offer participants who originally received placebo in this study the potential benefit of vaccination against COVID-19.”
The plan was hotly debated during the Dec. 17 Vaccines and Related Biological Products Advisory Committee meeting due to the potential loss of a control group, but Moderna has argued it has an obligation to the placebo patients, who have put their bodies on the line for the trial.
Health experts have also said that if the vaccine is not offered to placebo patients, they will drop out of the study to get one.
Pfizer also plans to eventually vaccinate all its study participants. It’s opting for a more gradual, voluntary process. The company will offer that option to those who got dummy shots as soon as they would have access to the vaccine outside of the study.
The companies will have to “unblind” the studies, revealing whether participants got the vaccine or the dummy shot, something that is not typically done until the end of testing.
“Volunteers have been instrumental,” said Moncef Slaoui, chief scientist of the government’s Operation Warp Speed program. “They should be rewarded for it.”
However, others argue that the only placebo patients that should get the vaccine should be those in priority groups that are eligible outside the trial, such as healthcare workers.
In a viewpoint article published in the Journal of the American Medical Association, authors including Harvard’s Dr. Marc Lipsitch wrote that vaccinating all the placebo participants, “would result in a major loss of valuable research data without eliminating undue risks to participants who continue in the placebo group of the trials.”
Unknowns surrounding the duration of protection the vaccine offers and long-term safety data remain, and the authors said, “The best way to resolve these uncertainties is to continue placebocontrolled trials.”
Moderna also announced it will make vaccine doses available to its workers, contractors and board members as well as adult household members of the employees.
The cost of the doses will be covered by Moderna, and the supply is separate from those committed to the U.S. government, according to the company.