Should vaccine volunteers now get real thing?

Tens of thousands of Americans have volunteered to test COVID-19 vaccines, but only about half of them got the real thing during trials.

Now, with the first vaccine rollouts and a surge in coronavirus infections, experts are debating what to do about the half that got a dummy shot.

Should everyone nowbe offered a vaccine? Or should the two groups in the Pfizer and Moderna studies remain intact in order to collect long-term data on how well the vaccines work?

“There’s a real tension here,” said Dr. Jesse Goodman, an infectious disease specialist and former chief scientist at the U.S. Food and Drug Administration. “There’s not an easy answer.”

About 17,000 of Moderna’s study participants received a placebo, as did about 22,000 people in Pfizer’s trial.

With the ongoing coronavirus crisis, health experts worry about leaving them in the dark and unprotected. They argue they should be given a vaccine now in recognition of their willingness to be a part of the trials during the pandemic.

“Volunteers have been instrumental,” said Moncef Slaoui, chief scientist of the government’s OperationWarp Speed program. “They should be rewarded for it.”

The companies would have to “unblind” or “unmask” the studies, revealing whether participants got the vaccine or thedummy shot.

Unmasking is usually done at the end of testing. Moderna and Pfizer, though, designed their studies to last two years to do longterm follow-up.

“I don’t think there’s anybody who thinks it’s reasonable or feasible to keep the people blinded for two years,” said Susan Ellenberg, an expert in clinical trials at the University of Pennsylvania.

“Given we have a pandemic, people are ready to settle for the short-term results.”

Pfizer 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.

Moderna is considering immediately offering the vaccine to all who got dummy shots. Over onequarter of them are health care workers and first in line for the vaccine anyway, the company noted.

“Many have already left. Sadly, it’s not a small number,” said Dr. Lindsey Baden, who’s involved in testing Moderna’s vaccine at Brigham andWomen’s hospital in Boston. “This is not theoretical. It’s happening.”

British pharmaceutical company AstraZeneca, which has enrolled at least 23,000 so far in its ongoing U.S. study, will offer individual participants the opportunity to be unmasked as they become eligible for the approved vaccines.