They acquired the placebo—ought to they be subsequent in line for vaccine?

A woman participates in a trial for the Moderna vaccine at a research center in Hollywood, Florida

Given that America will be the next country to approve a COVID-19 vaccine, authorities face an ethical dilemma: when should study participants who received a placebo get the right deal?

The question is most pressing for studies involving Pfizer-BioNTech’s two-shot regimen, which has received emergency clearance in the UK and a handful of other countries. The US could follow within a few days.

On Thursday, the prestigious New England Journal of Medicine published results from a clinical study that enrolled nearly 44,000 people in the US and other countries.

About half were randomly selected to be injected with the companies’ patented messenger RNA molecules, while the rest were given saline solutions.

The experiment was “blind,” which meant that neither the volunteers nor their health care providers knew who was being given what, a vital element in ensuring that people are going about their daily lives the way they would otherwise have done.

Independent researchers who analyzed the study waited for volunteers to become infected naturally – unfortunately, the widespread pandemic made it all too quick – and then opened the data hood so that they and only they could see which group had the sick were in.

The results confirmed that receiving the vaccine reduced the risk of developing COVID-19 by 95 percent compared to not receiving it, and that no serious side effects could be attributed to the drug.

A lab technician sorts blood samples for a Covid-19 vaccination study at the Research Centers of America in Hollywood, Florida
A lab technician sorts blood samples for a Covid-19 vaccination study at the Research Centers of America in Hollywood, Florida in August 2020

Why isn’t that enough to cancel the trial and make sure everyone benefits now?

Ideally, scientists would still want more data, for example to clarify possible long-term harms related to the vaccine.

“When you are a vaccine developer or a scientist, you recognize the importance of following people for as long as possible to see the differences between the vaccine arm and the placebo arm,” said Andrew Morris, professor at the University of Toronto Medicine, AFP said.

But at one point he said, “You have to name it” because “one of the things about people who volunteer for exams is that they took you on for the team – you have to have a way to pay it back. “

Benefit to society

Stanford Professor Steven Goodman spoke on the subject Thursday when a high-level committee convened by the Food and Drug Administration discussed the critical issue.

“An ethical dilemma is not a choice between right and wrong, we columnists write advice for that,” he said. Rather, competing interests were weighed up.

Placebo participants will receive the vaccine from the study organizer, Moncef Slaoui, pictured in November 2020
Placebo participants will receive the vaccine from Moncef Slaoui, the organizer of the study, which was pictured in November 2020

He argued that since the study participants are aware that the study is for the benefit of society, they do not have an absolute right to jump to the top.

Goodman suggested that people who received the placebo be notified on the day local and national authorities determine that people their age and risk group are eligible.

This would encourage them to stay in the process as they would be on the “front of their own line” and it would preserve the controlled nature of the experiment.

Pfizer, for its part, has proposed a similar plan, with the important exception that participants can also request to be told which group they are in earlier and offered the vaccine.

Another option, Goodman said, would be a “crossover” plan where people who received the vaccine the first round would then be given the placebo and vice versa, which would still provide useful data.

There are certain practical considerations.

If the FDA decides on rules that are too burdensome, people could just get out and damage confidence in future studies.

Spread of the coronavirus
World map with the number of Covid-19 deaths by country on December 10th at 1100 GMT

Now that we know all about the most common side effects of the vaccine, people can guess which group they belong to.

This can affect their public behavior and risk behavior.

Future test participation

Placebo participants will receive the vaccine from the study’s organizers, Moncef Slaoui, chief advisor to Operation Warp Speed ​​to the US government, said in a recent briefing. “The question is more when?”

A legal hard stop for the placebo group would come when a vaccine is fully licensed, which is expected a few months after emergency approval.

Slaoui added that without experimental control, researchers could still collect long-term data.

New puzzles would soon arise, however. Once one or more vaccines have been approved, it can become more difficult to motivate people to sign up for or participate in other vaccine studies.

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© 2020 AFP

Quote: You got the placebo – should you be in line for the vaccine next? (2020, December 11th) accessed on December 11th, 2020 from https://medicalxpress.com/news/2020-12-placeboshould-line-vaccine.html

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