The first two COVID-19 vaccines to complete clinical trials have been so successful they raise concerns for the next ones.
Is it ethical to give people a placebo when a lifesaving vaccine is available? Should those who received placebos in the first two trials be given preferential access to active vaccine to thank them for their sacrifice?
There is no consensus among ethicists and public health officials on either point.
Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the Trump administration program leading the vaccine development effort, said trial participants should be first in line to be vaccinated. They were not mentioned Tuesday in a meeting by the U.S. Centers for Disease Control and Prevention board that recommends who should get the vaccine first.
Candidate COVID-19 vaccines, one made by Pfizer/BioNTech and the other by Moderna, appear poised to receive FDA emergency use authorization within weeks after showing they are safe and more than 94% effective. The companies conducted large trials of 44,000 and 30,000 people, respectively, in which half of the volunteers received a placebo. Participants don't know which they received.
Typical vaccine trials last for two years. Both groups are followed to ensure safety and indicate how long the vaccine's protection will last. During a pandemic in which an American dies of COVID-19 every minute, officials determined a two-year delay unacceptable.
Ending the placebo group early comes at a price.
“We don’t have the full profile on these vaccines,” said Norman Baylor, president and CEO of Biologics Consulting and a former director of the Office of Vaccines Research and Review at the Food and Drug Administration.
Continuing to compare the placebo and active vaccine groups could help researchers better understand how different demographic groups, such as the elderly, respond to the vaccine and identify any unexpected longer-term health issues.
That information will never become available, Baylor said, if placebo recipients are vaccinated in the coming months.
What happens to those who got a placebo?
No one wants to penalize people who volunteered to help researchers learn about vaccine safety and effectiveness, said Dr. Walter Orenstein, associate director of the Emory Vaccine Center, former director of the immunization program at the CDC and a volunteer in the Moderna trial.
“I am concerned about the ethics if I can’t get it, whereas everybody else with my characteristics can get it,” said Orenstein, who sits on Moderna’s Scientific Advisory Board. “When it’s made available to the people in my category, I should be able to be unblinded and get it.”
Trial participants shouldn't be moved to the head of the line, said Franklin Miller, a professor of medical ethics at Weill Cornell Medical College in New York.