Tens of thousands of Americans volunteered to test for COVID-19 vaccines, but only about half of them received the real thing during the studies.
Now, with the launch of the first vaccines and the increase in the number of coronavirus infections, experts are debating what to do about the half that got a fake shot.
Should everyone be given a vaccine now? Or should the two groups in the Pfizer and Moderna studies remain intact to collect long-term data on how well vaccines work?
“There’s a real strain here,” said Dr. Jesse Goodman, an infectious disease specialist and former scientist with the US Food and Drug Administration. “There is no easy answer.”
HOW VACCINE STUDIES WORK
New drugs, vaccines or treatments usually go through rigorous testing and evaluation before reaching regulatory authorities for approval.
For vaccines, researchers compare what happens when a large group of volunteers receive blows, compared to what happens to another large group that does not. They compare the side effects in each group. They also measure the effectiveness of the vaccine by examining how many in each group catch the infections.
To do this fairly, the researchers randomly assigned participants to receive a vaccine or a fake shot, usually a dose of salt water.
Volunteers know that there is a 50-50 chance that they can be placed in each group – and they are not told in which group they landed. Often, researchers or others involved in testing are also “blinded” and don’t even know it.
SHOULD TEST VOLUNTEERS BE TOLD?
About 17,000 study participants at Moderna received a placebo, as did about 22,000 people in the Pfizer trial.
With the ongoing coronavirus crisis, health experts are worried that they will be left in the dark and unprotected. They say they should now be given a vaccine in recognition of their willingness to be part of pandemic studies.
“Volunteers were essential,” said Moncef Slaoui, chief scientist of the government’s Operation Warp Speed program. “They should be rewarded for that.”
Companies should “desorb” or “unmask” the studies, revealing whether participants received the vaccine or the fake vaccine.
Unmasking is usually done at the end of the test. Moderna and Pfizer, however, designed their studies to last two years to make a long-term pursuit.
“I don’t think there’s anyone who thinks it’s reasonable or feasible to keep people blind for two years,” said Susan Ellenberg, an expert in clinical trials at the University of Pennsylvania.
“Given that we have a pandemic, people are ready to be satisfied with the short-term results.”
PROS AND CONTRACTS OF “RELEASE”
With the launch of vaccines and the uncertainty of their status, volunteers may decide to give up once they are eligible to receive one. They could stay in the study if told what they have, said Dr. Ana Iltis, a bioethicist at Wake Forest University.
“Participants could leave en masse. They might say, “If you don’t tell me what I have, I’m out of here,” Iltis said. “You can’t force people to stay.”
In an ideal world, participants might resist finding out if they received the vaccine or the vaccine. But experts agree that the current circumstances are extraordinary.
However, unmasking the participants would undoubtedly affect the scope and results of the tests.
If someone finds out that they have already been vaccinated, for example, they can stop social distancing or wear masks – increasing potential exposure to the virus and possibly spreading it. It is not yet known whether vaccinated people can still carry and transmit the virus.
On the other hand, if a person finds out that they only received the fake blow, they may take precautions otherwise.
Any of the results, Goodman said, “means the process is practically over.”
Before granting emergency use approval, the FDA requested Pfizer and Moderna will provide two-month follow-up data. If the studies are shortened, it becomes more difficult to get long-term effects, including how long the immunity lasts.
“There’s a reason we do clinical research in a certain way,” Iltis said. “We should not abandon our rules and principles. Will we be satisfied with the short-term evidence in a year? “
WHAT COMPANIES SAY
Pfizer intends to eventually vaccinate all study participants. We opt for a more gradual, voluntary process. The company will offer this option to those who obtained immediate photos as soon as they had access to the vaccine outside the study.
Moderna intends to immediately offer the vaccine to all those who received inaccurate photos. More than a quarter of them are health workers and the first in line for the vaccine, the company said.
“Many have already left. Unfortunately, this is not a small number, “said Dr. Lindsey Baden, who is involved in testing the Moderna vaccine at Brigham and Women’s Hospital in Boston. “It simply came to our notice then. It happens.”
The British pharmaceutical company AstraZeneca, which has so far enrolled at least 23,000 in its ongoing US study, recently decided to offer individual participants the opportunity to be exposed as they become eligible for approved vaccines.
“You never really want to go blind,” said Dr. William Hartman, a researcher for the AstraZeneca process at the University of Wisconsin-Madison.
However, he added, the pandemic has complicated things.
“A lot of people are nervous and scared,” Hartman said. “And everyone is entering the process hoping to get the vaccine.”
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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.