People in clinical trials seek unblinding as they become eligible for other vaccines
More than half a million Michiganders have received a first dose of either the Pfizer or Moderna vaccine, according to the state's health department. But a smaller cohort, as participants in clinical trials, have received vaccines made by other companies.
Those studies are still underway, which means that many subjects, recruited specifically for their priority status in the vaccine line, now have the option to get one of the authorized vaccines. The people leading these trials at Michigan health systems find themselves responding in two ways.
“As a physician, this is a great problem to have, because it means that we have enough safe and effective vaccine that we can vaccinate most of our high-risk patients,” said Dr. Kathleen Linder, one of the principal investigators for the Ann Arbor VA’s arm of the Novavax trial. “But as a researcher, it is a little challenging.”
Dr. Linder said her team expected to enroll lots of older veterans. But with many of those people now eligible to get either the Pfizer or Moderna vaccine, the researchers are adapting. Now, younger folks and non-veterans are joining the trial. As of Friday, Dr. Linder and her colleagues had brought on 48 people. Their goal is to reach 250 in eight weeks.
The experience has been different for researchers who started recruitment before Pfizer and Moderna received emergency use authorizations from the FDA. Dr. Anna Lok, of Michigan Medicine, described a late-December “nightmare” of having to manage dozens of trial subjects asking to be unblinded — that is, told whether they received the vaccine, or a placebo.
Michigan Medicine is participating in two COVID vaccine trials: AstraZeneca’s, and Johnson & Johnson’s. As the assistant dean for clinical research at the health system, Dr. Lok not only oversees the trials, but also helps out in the clinic. That includes talking through options with a subject who’s become eligible to get a vaccine outside of the trial setting.
“For a couple of weeks, we were working night and day, over the weekend, dealing with all these people saying that, ‘I have been given an appointment tomorrow, I need the unblinding tonight,’” she said.
Of about 400 participants in the two trials, about 150 have requested their unblinding. Many were frontline, and front-of-line, health care workers. Dr. Lok, like Dr. Linder, felt tugged at by two instincts. On the one hand, unblinding more than a third of participants was a disappointment, because doing so could spoil the trial data.
But, she said, “We were also very excited for those people.” She also noted that Michigan Medicine is just one of many sites taking part in the international trials.
Wayne State University, which has an on-campus clinic at its Integrative Biosciences Center, is also recruiting patients for the Novavax trial, the same one running at the VA.
The site’s principal investigator, Dr. Elizabeth Secord, says she and her colleagues started the month off “somewhat worried.” They were just beginning to recruit patients when Governor Gretchen Whitmer announced that people 65 and older would be eligible to receive the Pfizer or Moderna vaccine. They thought they would struggle to compete.
“However, now that it’s become clear that the vaccine is in limited supply, we have been hearing from more people,” said Dr. Secord.
Wayne State hopes to enroll 300 participants total (the entire Novavax trial is aiming for 30,000). Last week, their first of enrollment, they brought in a handful. But Dr. Secord says she encourages people who can get a vaccine appointment now to take it rather than enroll in her trial.
“I don’t think the sponsor necessarily wants me to say that, but I’m going to say that,” she said. “If you’re really high in the queue to get the vaccine, then it’s better to wait,” she said.