Health
Are the side effects of some vaccines in our heads?
Patients receiving the COVID-19 vaccine during the clinical trial reported more adverse events (AEs) compared to placebo, but the number of AEs reported in the placebo group was disproportionately high. A systematic review and meta-analysis was found.
Despite not receiving the active vaccine, about one-third of placebo recipients reported at least one systemic AE after both doses, said Dr. Julia Haas and colleagues at the Beth Israel Deaconess Medical Center in Boston. Reported.
In fact, the so-called “nosebo response” in the active arm is likely to account for 76% of reported systemic AEs after the first vaccination and 52% of the AEs after the second vaccination, the authors said. Are writing. JAMA network opened.
These reactions are “believed to be caused by routine background symptoms, anxiety, and misunderstandings of AE expectations,” the team added, but they have not yet been systematically quantified in the COVID vaccine trial.
The Haas group surveyed data from 12 clinical trials with a total of 22,578 placebo recipients and 22,802 vaccine recipients. The vaccines included were from Moderna, Pfizer, Novavax, Sanofi Pasteur, AstraZeneca, Clover, and Johnson & Johnson. Six of the twelve trials were at least partially US-based, and four were conducted in the United States only. It was held twice each in Australia and South Africa.
In the placebo group, 35.2% (95% CI 26.7% -43.7%) of recipients reported at least one systemic AE after the first dose, and 31.8% (95% CI 28.7% -35.0%) a second. I reported this after administration.
In contrast, 46.3% (95% CI 38.2% -54.3%) and 66.7% (95% CI 53.2% -80.3%) of vaccine recipients reported systemic AE after the first and second doses, respectively. did.
Haas’ team said that the second dose of the vaccine produced “both a stronger immune response and a correspondingly stronger series of AEs. […] Participants in the vaccine group experienced more AE after the first dose than participants in the control group and then had higher expectations for AE after the second dose compared to participants in the placebo group. “
The most commonly reported systemic AEs in the placebo group were headache (19% after the first dose, 16% after the second dose) and fatigue (17% after the first dose, after the second dose). 15%). Specifically, the authors stated that headache, fatigue, fatigue, and joint pain are common in both groups and may be “especially associated with nosebo.”
The Haas team also conducted an exploratory analysis of the two largest trials for AE severity: “AE severity, with or without AE, is an additional indicator for quantifying the effects of nocebo response. It could be useful. “
The percentage of severity was similar for the vaccine after the first dose and the placebo participants, but there was “proportional more moderate and severe AE” in the vaccine group after the second dose.
According to the author, data limitations include a small number of tests and high non-uniformity due to the lack of standardized data. From different methods of assessing AE to different probabilities of receiving different vaccines, vaccines or placebos tested.
Haas’s group proposed revised language for education on the nosevo response by both vaccine manufacturers and the media, suggesting: , “This was used in one study to reduce drug-related AEs.
“Such honest information is added to the full disclosure and is unlikely to cause any harm,” the researchers said, which could help reduce vaccine hesitation.
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Disclosure
Haas disclosed support from the German Academic Exchange Service.
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