Tens of thousands of volunteers to study the Pfizer-BioNTech and Moderna COVID-19 vaccines are still in the follow-up study. However, some important questions cannot be easily answered, as many people who belonged to the placebo group are now choosing to vaccinate.
Still, there is valuable information available from the planned two-year follow-up. And it motivated Karen Mott, a 56-year-old job counselor who stuck to ongoing research.
“I’ve been taking prescription drugs for the last 25 years,” she says, referring to the anticonvulsants she’s taking. To show that those drugs worked, people previously volunteered to take them when they were still experimental, “so I feel it’s a way of giving back. I did. “
Mott, who lives in Overland Park, Kansas, responded so strongly to the second shot that he correctly speculated that he had been vaccinated with the modelna vaccine instead of the placebo. She was saddened to read that one of the volunteers in the placebo group died of COVID-19.
“I keep thinking about it. Why am I one of the lucky ones?” She says. “So I feel like I need to keep providing the information I need.”
So when the clinic called her in January and offered to reveal her actual vaccine status, it was a simple call to her. She agreed to continue participating in the two-year follow-up.
Participants will be provided with nasal swabs and saliva samples on a regular basis to see if they are infected. They also give blood so scientists can better understand how vaccines provide protection.
Mott was one of about 650 volunteers vaccinated with the experimental moderna vaccine at the company. Johnson County Clinical Trial Dr. Carlos Fierro, who is studying there in Renexa, says all participants were recalled after the Food and Drug Administration approved the vaccine.
“During that visit, we talked about options, including staying in the study without a vaccine, and, surprisingly, there were a few people who chose it,” he says.
He suspects that those individuals may have been surprised by rumors about the vaccine. But everyone else who was injected with placebo went on and got the actual vaccine. As a result, Fiero currently has essentially no comparison groups left for ongoing research.
“It’s a loss from a scientific point of view, but given the situation, I think it’s the right thing to do,” he says.
Those who signed up for these studies were not promised any special treatment, but when the FDA approved the vaccine, their developers decided to provide shots.
Dr. Stephen GoodmanA clinical trial specialist at Stanford University says that losing these controls makes it more difficult to answer some important questions about the COVID-19 vaccine.
“I don’t know how long the protection will last,” he says. “We don’t know the effectiveness for variants — we certainly need a good control arm for that — and whether there are differences in any of these parameters depending on age, race, or weakness. I do not know.”
Scientists may be able to speculate on some of this, for example, if it turns out that vaccinated people generally get sick after exposure to a viral variant. Further safety information is also being collected by the Centers for Disease Control and Prevention and the FDA, based on the experience of the millions of people currently taking shots.
However, clinical trials involving the placebo group are the most reliable and reliable way to collect information on vaccine efficacy. “I think we’ll get that data over time,” says Fiero, even without the placebo group.
Scientists have already collected data from vaccine studies and may be able to help identify how an individual’s immune system responded to vaccination. Ultimately, this may allow us to identify immune system characteristics called defense correlations that may strongly indicate the effectiveness of the vaccine.
But the best evidence comes from controlled studies, so Goodman is thinking about how to implement them ethically now that effective vaccines are available.
One option is to identify people in groups who are not currently vaccinated, as is happening to children now. Another option is to conduct the study in other parts of the world where the vaccine is simply not available. But it also raises ethical issues. Why not provide vaccines to those countries instead of recruiting them for research?
“But in reality, we have an unfair world, and there is inequality in global health and funding,” says Goodman. Therefore, it can be ethical to provide people with the opportunity to participate in research. “The country itself may demand it,” he says, working to understand the risks that viral variants pose to their populations.
Another option is to perform a study in which all participants are vaccinated but not immediately. For example, two months later, people will receive a second treatment. If you first get a placebo, it’s a real vaccine, or vice versa. The important thing here is that no one knows which is which. That way, people will not change their behavior. By itself, people who know they are vaccinated can take greater risks and can affect the results of their trials.
“The emergence of viral variants is really confusing, as all vaccines are very ineffective and there may be certain variants that can basically return to zero,” Goodman said. There is a possibility. ” “You may have to go back to a placebo-controlled trial. It’s hard to know.”
That is the worst scenario. Vaccines currently used in the United States work well against the first variants found in the United Kingdom and appear to be at least partially protected from the first identified variants in South Africa, but more avoided. New variants may emerge within a few months. The coming year.
Fiero sees another possibility. Perhaps in a year or two, existing vaccines have proven to be very effective, making COVID-19 just a nuisance. In such situations, the risk of participating in a study with placebo options would be acceptablely low, for example, for adolescents who have not yet been vaccinated.
You can contact Richard Harris, correspondent for NPR Science [email protected]..
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