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Tens of thousands of Americans have volunteered to test COVID-19 vaccines, but only about half of them got the real thing in testing.
Now, with the first vaccine deployments and an increase in coronavirus infections, experts are debating what to do about the half who received a dummy injection.
Should everyone now be offered a vaccine? Or should the two study groups Pfizer and Moderna remain intact in order to collect long-term data on vaccine effectiveness?
“There is real tension here,” said Dr. Jesse Goodman, infectious disease specialist and former chief scientist at 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 regulators for approval.
For vaccines, researchers compare what happens when a large group of volunteers get vaccinated, to what happens to another large group who does not. They compare the side effects in each group. And they measure the effectiveness of the vaccine by looking at how many in each group are getting infections.
To do this fairly, the researchers randomly assign participants a vaccine or dummy injection, usually a dose of salt water.
Volunteers know there is a 50-50 chance that they’ll be placed in either group – and they are not told which group they ended up in. Often times, researchers or others involved in testing are also “blinded” and not knowing it either.
SHOULD YOU TELL TEST VOLUNTEERS?
About 17,000 of the participants in the Moderna study received a placebo, as were about 22,000 people in the Pfizer trial.
With the current coronavirus crisis, health experts fear leaving them in the dark and unprotected. They argue they should receive a vaccine now in recognition of their willingness to be part of the trials during the pandemic.
“Volunteers were instrumental,” said Moncef Slaoui, chief scientist of the government program Operation Warp Speed. “They should be rewarded for it.”
Companies should “unblind” or “unmask” studies, revealing whether participants received the vaccine or the dummy vaccine.
Unmasking is generally performed at the end of the tests. Moderna and Pfizer, however, designed their studies to last for two years for long-term follow-up.
“I don’t think anyone thinks it’s reasonable or feasible to keep people blind for two years,” said Susan Ellenberg, clinical trials expert at the University of Pennsylvania.
“Since we have a pandemic, people are prepared to be content with short-term results.”
ADVANTAGES AND DISADVANTAGES OF “UNMASKING”
With the vaccine rollout and the uncertainty of their status, volunteers might decide to give up once they are eligible to get one. They could stay in the study if they told them what they got, said Dr Ana Iltis, a bioethicist at Wake Forest University.
“The 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 wait to find out whether they received the dummy vaccine or the vaccine. But experts agree that the current circumstances are extraordinary.
Nonetheless, unmasking the participants would undoubtedly affect the scope and results of the trials.
If a person learns that they have already been vaccinated, for example, they may stop walking away from society or wearing masks – thus increasing their potential exposure to the virus and possibly spreading it. It is not yet clear whether people who have been vaccinated can still carry and transmit the virus.
On the other hand, if a person finds out that they have only received the fake vaccine, they might take precautions that they would not otherwise.
Whatever the outcome, Goodman said, “means the trial is pretty much over.”
Before granting emergency use approval, the FDA required Pfizer and Moderna will provide two months of tracking data. If the studies are stopped, it becomes more difficult to obtain long-term effects, including the duration of immunity.
“There’s a reason we do clinical research in a certain way,” Iltis said. “We must not abandon our standards and our principles. Are we going to be satisfied with the short-term evidence a year from now? “
WHAT COMPANIES ARE SAYING
Pfizer plans to eventually vaccinate all of its study participants. It is opting for a more progressive voluntary process. The company will offer this option to those who have received dummy injections as soon as they have access to the vaccine outside of the study.
Moderna plans to immediately offer the vaccine to anyone who has received dummy injections. More than a quarter of them are healthcare workers and are the first to receive the vaccine anyway, the company noted.
“Many have already left. Unfortunately, that’s 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’s not theoretical. It happens. “
British pharmaceutical company AstraZeneca, which has enrolled at least 23,000 to date in its ongoing US study, recently decided to offer individual participants the opportunity to be unmasked when they become eligible for approved vaccines.
“You never really want to cancel the blind,” said Dr. William Hartman, investigator for the AstraZeneca trial at the University of Wisconsin-Madison.
However, he added, the pandemic has complicated matters.
“A lot of people are nervous and scared,” Hartman said. “And everyone is participating in the trial hoping to receive the vaccine.”
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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