Tens of thousands of Americans have volunteered to test for COVID-19 vaccines, but only about half received the exact same thing at the time of testing.
Should everyone be offered the vaccine now? Or should the two groups in the Pfizer and Moderna studies stay intact to collect long-term data on how well the vaccines are working?
“There is a real tension here,” said Dr. Jesse Goodman, an infectious disease specialist and former scientist at the U.S. Food and Drug Administration. “There is no easy answer.”
HOW GOOD IS VACCINE INSPECTION
New drugs, vaccines or treatments usually go through rigorous testing and assessments before reaching regulators for approval.
For vaccines, researchers compare what happens when a large group of volunteers gets the sights, compared to what happens to another large group that does not. They compare side effects in each group. And they measure the effectiveness of the vaccine by looking at how many in each group develop infections.
To do this fairly, researchers randomly assign participants to a vaccine or bullet, usually a dose of salt water.
Volunteers know there is a 50-50 chance they could be placed in any group – and are not told which group they came from. Often, the researchers or other people involved in the experiment are also “blind” and do not know either.
CAN THE WORLD OWN?
Approximately 17,000 participants received the Moderna placebo study, as did approximately 22,000 people in the Pfizer trial.
With the ongoing coronavirus crisis, health experts are concerned about leaving them in the dark and unprotected. They argue that they should be vaccinated now in recognition of their willingness to be part of the tests during the pandemic.
“Volunteers have been very involved,” said Moncef Slaoui, chief scientist on the government’s Operation Warp Speed program. “They should be rewarded for it.”
The companies had to “investigate” or “unmask” the studies, revealing whether participants received the vaccine or the false impression.
Unmasking is usually done at the end of the test. Moderna and Pfizer, however, designed their learning to last two years to carry out long-term follow-up work.
“I don’t think there’s anyone who thinks it’s reasonable or possible to keep people blind for two years,” said Susan Ellenberg, an expert in clinical trials at the University of Pennsylvania.
“Because we have a pandemic, people are ready to settle for the short-term consequences.”
PROS AND CONS of “UNMASKING”
With the distribution of vaccines and uncertainty about their status, volunteers may decide to suspend once they are eligible for one. They may stay in the study if told what they found, said Dr. Ana Iltis, a biologist at Wake Forest University.
“Participants could leave in droves. They might say, ‘If you don’t tell me what I found, I’m out of here,’ ‘Iltis said. “You can’t make people stay.”
In an extreme world, participants could stay away to find out if they got the funny picture or the vaccine. But experts agree that the current situation is remarkable.
However, unmasking participants would undoubtedly have an impact on the scope and results of the trials.
If someone learns that they have already been vaccinated, for example, they may stop socializing or wear masks – increasing their exposure to the virus and possibly spreading it. It is not yet known whether vaccines can carry and transmit the virus.
On the flip side, if someone finds out they only got the fake picture, they may warn that they would not do otherwise.
One outcome, Goodman said, “means that the trial is over.”
Before granting permission for emergency use, the FDA asked Pfizer and Moderna to provide two months of follow-up data. If studies are cut short, it will be more difficult to obtain long-term effects, including how long immunity lasts.
“There is a reason we conduct clinical research in a particular way,” Iltis said. We should not ignore our norms and principles. Are we going to be happy with short-term evidence in a year? ”
WHAT THE HELP TAKES
Pfizer plans to vaccinate its study partners. He chooses a more gradual, voluntary process. The company offers that option to those who received small pictures as soon as they had access to the vaccine outside of the examination.
Moderna is immediately considering offering the vaccine to everyone who has received bad pictures. More than a quarter of them are health care workers and initially according to the vaccine at least, the company noted.
“There is already a lot left. Sadly, 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. “This is not theoretical. It happens. ”
British pharmaceutical company AstraZeneca, which has so far recorded at least 23,000 in its ongoing study of the US, has decided to allow individual participants to remain unregistered while they are eligible for the permitted vaccines.
“You will never want to disconnect,” said Dr. William Hartman, a researcher for the AstraZeneca test at the University of Wisconsin-Madison.
However, he said, the pandemic is a difficult one.
“A lot of people are anxious and scared,” Hartman said. “And everyone comes into court in the hope of getting the vaccine. “
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The Department of Health and Science Associated Press is supported by the Science Education Department of the Howard Hughes Medical Institute. The AP is solely responsible for all content.