Explainer: Should Vaccine Volunteers Get the Real Now?

“There’s real tension here,” said Dr. Jesse Goodman, an infectious disease expert and former NASA Chief Scientist at the US Food and Drug Administration. “There is no easy answer.”

New drugs, vaccines, or treatments are usually rigorously tested and evaluated before seeking approval from regulators.

In the case of vaccines, researchers compare what happens when a large group of volunteers take a shot with what happens to another large group that doesn’t. They compare the side effects of each group. They then measure the effectiveness of the vaccine by looking at how many people in each group pick up the infection.

To do this fairly, researchers randomly assign participants to receive vaccines or dummy shots (usually saline doses).

Volunteers know that there is a 50-50 chance of being in either group. Also, I don’t know which group I landed on. In many cases, the researchers and others involved in the test are also “blind” and do not know either.

Should I talk to a test volunteer?

Approximately 17,000 Modena study participants received a placebo, and approximately 22,000 in the Pfizer trial received a placebo.

Due to the ongoing coronavirus crisis, health professionals are worried about leaving them unprotected in the dark. They acknowledged their willingness to participate in the pandemic trial and insisted that they should be vaccinated now.

“Volunteers have worked hard,” said Monsef Slawi, chief scientist for the Government’s Operation Warp Speed ​​program. “They should be rewarded for it.”

Companies need to “unblind” or “unmask” their studies to determine whether participants have been vaccinated or dummy shots.

Unmasking is usually done at the end of the test. However, Moderna and Pfizer designed the study to last for two years for long-term follow-up.

“I don’t think anyone thinks it’s rational or feasible to blind people for two years,” said Susan Elenberg, a clinical trials expert at the University of Pennsylvania.

“Given the pandemic is happening, people are ready to settle for short-term results.”

Advantages and disadvantages of “unmasking”

Due to the deployment of the vaccine and the uncertainty of its status, volunteers may decide to drop out when they are eligible to get the vaccine. Dr. Ana Iltis, a bioethicist at Wake Forest University, said they might stay in the study if they were informed of what they had gained.

“Participants were able to leave in large numbers. They could say,’If you don’t tell me what I got, I’m out of here,'” Iltis said. “You can’t force people to stay.”

In an ideal world, participants can postpone discovering whether they have received a dummy shot or a vaccine. However, experts agree that the current situation is unusual.

Nevertheless, unmasking participants will definitely affect the scope and results of the exam.

For example, if someone learns that they have already been vaccinated, they can stop social distance and wear masks, increase their potential exposure to the virus, and in some cases spread the virus. There is a sex. It is not yet known if vaccinated people can carry the virus and infect it.

On the other hand, if you find that you are only receiving dummy shots, you may take precautions otherwise.

Both results said Goodman “means that the trial is basically over.”

Prior to granting an emergency use authorization, the FDA requested Pfizer and Moderna to provide two months of tracking data. Shorter studies make it harder to get long-term benefits, such as how long immunity lasts.

“There’s a reason we do clinical research in a particular way,” says Iltis. “We should not abandon our norms and principles. Will we be satisfied with the short-term evidence within a year?”

Pfizer will eventually vaccinate all study participants. It is choosing a more gradual and voluntary process. The company will offer that option to those who take dummy shots as soon as the vaccine becomes available outside the study.

Moderna is considering providing the vaccine immediately to everyone who has taken a dummy shot. More than a quarter of them are healthcare workers, and they are in the first line of vaccines anyway, the company said.

“Many are already gone. Sadly, not a few,” said Dr. Lindsey Baden, who is testing Moderna’s vaccine at Brigham and Women’s Hospital in Boston. “This is not theoretical. It’s happening.”

UK pharmaceutical company AstraZeneca, which has so far enrolled at least 23,000 people in an ongoing U.S. study, has recently offered individual participants the opportunity to unmask when qualified for an approved vaccine. I decided that.

Dr. William Hartman, a researcher at the AstraZeneca trial at the University of Wisconsin-Madison, said:

But he added that pandemics can be complicated.

“Many people are nervous and scared,” Hartman said. “And everyone participates in the trial in the hope that they will be vaccinated.”

The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

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