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July 21, 2020 11:20 pm

COVID-19 Vaccines With 'Minor Side Effects' Could Still Be Pretty Bad

"The risk of nasty side effects in the Moderna and Oxford trials should be made clear now, before it ends up as fodder for the skeptics," argues Hilda Bastian, a former consumer health care advocate and a Ph.D. student at Bond University who studies evidence-based medicine. An anonymous reader shares an excerpt from her article via Wired: On Monday, vaccine researchers from Oxford University and the pharmaceutical company AstraZeneca announced results from a "Phase 1/2 trial," suggesting their product might be able to generate immunity without causing serious harm. Similar, but smaller-scale results, were posted just last week for another candidate vaccine produced by the biotech firm Moderna, in collaboration with the U.S. National Institutes of Health. [...] Back in May, a CNN report described the Oxford group as being "the most aggressive in painting the rosiest picture" of its product, so let's start with them. Just how rosy is the Oxford picture really? It's certainly true that this week's news shows the vaccine has the potential to provide protection from Covid-19. But there are flies in the ointment. After the first clinical trial for this vaccine began in April, for example, the researchers added new study arms in which people got acetaminophen every six hours for 24 hours after the injection. That's not featured in their marketing, of course, and I saw no discussion of this unusual step in media coverage in early summer. Newspapers only said the vaccine had been proven "safe with rhesus monkeys," and did not cause any adverse effects in those animal tests. It was a worrying signal though: How rough a ride were people having with this vaccine? Was the acetaminophen meant to keep down fever, headaches, malaise -- or all of the above? The press release for Monday's publication of results from the Oxford vaccine trials described an increased frequency of "minor side effects" among participants. A look at the actual paper, though, reveals this to be a marketing spin that has since been parroted in media reports. Yes, mild reactions were far more common than worse ones. But moderate or severe harms -- defined as being bad enough to interfere with daily life or needing medical care -- were common, too. Around one-third of people vaccinated with the Covid-19 vaccine without acetaminophen experienced moderate or severe chills, fatigue, headache, malaise, and/or feverishness. Close to 10 percent had a fever of at least 100.4 degrees and just over one-fourth developed moderate or severe muscle aches. That's a lot, in a young and healthy group of people -- and the acetaminophen didn't help much for most of those problems. The paper's authors designated the vaccine as "acceptable" and "tolerated," but we don't yet know how acceptable this will be to most people. There is another red flag. Clinical trials for other Covid-19 vaccines have placebo groups, where participants receive saline injections. Only one of the Oxford vaccine trials is taking this approach, however; the others instead compare the experimental treatment to an injected meningococcal vaccine. There can be good reasons to do this: Non-placebo injections may mimic telltale signs that you've received an active vaccine, such as a skin reaction, making the trial more truly "blind." But their use also opens the door to doubt-sowing claims that any harms of the new vaccine are getting buried among the harms already caused by the control-group, "old" vaccines.What about the Moderna vaccine? "According to the press release from May, there were no serious adverse events for the people in that particular dosage group," reports Wired. "But last week's paper shows the full results: By the time they'd had two doses, every single one was showing signs of headaches, chills or fatigue; and for at least 80 percent this could have been enough to interfere with their normal activities. A participant who had a severe reaction to a particularly high dose has talked in detail about how bad it was: If reactions even half as bad as this were to be common for some of these vaccines, they will be hard sells once they reach the community -- and there could be a lot of people who are reluctant to get the second injection."

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