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posted by martyb on Wednesday January 19, @10:36PM   Printer-friendly
from the it's-[almost]-all-in-your-head? dept.

More Than Two-Thirds of Adverse COVID-19 Vaccine Events Are Due to Placebo Effect:

The placebo effect is the well-known phenomenon of a person's physical or mental health improving after taking a treatment with no pharmacological therapeutic benefit – a sugar pill, or a syringe full of saline, for example. While the exact biological, psychological, and genetic underpinnings of the placebo effect are not well understood, some theories point to expectations as the primary cause and others argue that non-conscious factors embedded in the patient-physician relationship automatically turn down the volume of symptoms. Sometimes placebo effects can also harm –the so-called "nocebo effect" occurs when a person experiencing unpleasant side effects after taking a treatment with no pharmacological effects. That same sugar pill causing nausea, or that syringe full of saline resulting in fatigue.

In a new meta-analysis of randomized, placebo-controlled COVID-19 vaccine trials, researchers at Beth Israel Deaconess Medical Center (BIDMC) compared the rates of adverse events reported by participants who received the vaccines to the rates of adverse events reported by those who received a placebo injection containing no vaccine. While the scientists found significantly more trial participants who received the vaccine reported adverse events, nearly a third of participants who received the placebo also reported at least one adverse event, with headache and fatigue being the most common. The team's findings are published in JAMA Network Open.

"Adverse events after placebo treatment are common in randomized controlled trials," said lead author Julia W. Haas, PhD, an investigator in the Program in Placebo Studies at BIDMC. "Collecting systematic evidence regarding these nocebo responses in vaccine trials is important for COVID-19 vaccination worldwide, especially because concern about side effects is reported to be a reason for vaccine hesitancy."

Haas and colleagues analyzed data from 12 clinical trials of COVID-19 vaccines. The 12 trials included adverse effects reports from 22,578 placebo recipients and 22,802 vaccine recipients. After the first injection, more than 35 percent of placebo recipients experienced systemic adverse events – symptoms affecting the entire body, such as fever – with headache and fatigue most common at 19.6 percent and 16.7 percent, respectively. Sixteen percent of placebo recipients reported at least one local event, such as pain at site of injection, redness, or swelling.

In comparison after the first injection, 46 percent of vaccine recipients experienced at least one systemic adverse event and two-thirds of them reported at least one local event. While this group received a pharmacologically active treatment, at least some of their adverse events are attributable to the placebo – or in this case, nocebo – effect, as well given that many of these effects also occurred in the placebo group. Haas and colleagues' analysis suggested that nocebo accounted for 76 percent of all adverse events in the vaccine group and nearly a quarter of all local effects reported.

Journal Reference:
Julia W. Haas, Friederike L. Bender, Sarah Ballou, et al. Frequency of Adverse Events in the Placebo Arms of COVID-19 Vaccine Trials [open], JAMA Network Open (DOI: 10.1001/jamanetworkopen.2021.43955)


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  • (Score: 5, Insightful) by Thexalon on Thursday January 20, @04:36AM (1 child)

    by Thexalon (636) on Thursday January 20, @04:36AM (#1214065)

    A brief admittedly anecdotal story about this: The guy who delivers my heating oil, who hates the previous US president mostly because said ex-president cheated him and his company on a construction contract a while ago, got his Covid vaccine as quickly as he could. His wife was more reluctant, but her employer mandated vaccination, and she broke down and got it rather than get fired. So they're going about their lives, and shortly after Christmas several of the relatives who were present at the family gathering got sick, and 2 had to spend time in the hospital, because it turned out that one of the people present had Covid. But you know who didn't get sick? The people who were vaccinated. Within a week, the relatives who hadn't been at that Christmas dinner got vaccinated.

    As for the flawed logic you're talking about here:
    - You're using "No one I know had it bad" to justify the conclusion "Probability is negligible". But "no one I know" isn't "no one", and not even "no one I come in contact with", because if you're like most people, you fairly regularly come in contact with people you don't know such as the random person who you walked by in your local Walmart or the person who dropped off your Amazon order.
    - "My vaccinated neighbors all got it": How many neighbors do you have? How severe was it? Were any of them hospitalized? Did any of them die from it? Because it sure sounds like what you're saying is that the correct thing to do is to oversimplify your data, limit your sample size dramatically, and ignore any wider information that might contradict that data set. Which is equivalent logic to: "All of my neighbors got around 20 inches of snow this week, so that must mean everybody in the US got 20 inches of snow this week. After all, that's what I'm seeing, and everybody at NOAA and TV weather reports might be lying to me."

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  • (Score: 0) by Anonymous Coward on Thursday January 20, @02:27PM

    by Anonymous Coward on Thursday January 20, @02:27PM (#1214154)

    - "My vaccinated neighbors all got it": How many neighbors do you have? How severe was it? Were any of them hospitalized? Did any of them die from it?

    My boss got it and his child that was in school. Both vaccinated.

    Caveat: boss had sore throat for 1 day. The child had positive test before it turned negative 3 days later.

    So, you can stretch what "got it" == "vaccine not work", but it seems that it's working quite well. Another nice stats, for unvaccinated Omicron is 1/3 as deadly as Delta. For the vaccinated, it's less deadly than seasonal flu.