27 March 2021  /  Updated 17 July 2021
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major risk & ethical issue with vaccine


BuildVaccineTrust
Posts: 6
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(@buildvaccinetrust)
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I've tried emailing lockdownskeptics but gotten no response about this issue, and my prior related post is getting old. There is a major risk factor with the vaccine that isn't being disclosed to recipients in the UK, US or Canada (the info below was written for the US but applies to the UK as well) and the Moderna vaccine has the same issue. Below is a repost of what a comment I made on a Science magazine blog a day ago here:

https://blogs.sciencemag.org/pipeline/archives/2020/12/18/antibody-dependent-enhancement

The Emergency Use Authorization for the Pfizer vaccine, and its briefing document for the review meeting, states there is an unknown risk of future vaccine enhanced disease after the initial immunity fades:

https://www.fda.gov/media/144416/download
"The Sponsor identified vaccine-associated enhanced disease including vaccine-associated enhanced respiratory disease as an important potential risk [....] risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials and in observational studies that could be conducted following authorization and/or licensure."

I saw almost the same text in the briefing document for Moderna's FDA review.

i.e. the study simply hasn't gone on long enough to see if people have sterilizing immunity producing the initial good results that fades, and then when people do actually get infections: the immune response they learned from the vaccine might lead to a worse case of covid-19. Hopefully not: but the trials just haven't run long enough to demonstrate that.

Yet the FDA isn't telling patients about this risk, nor is the media. The FDA's fact sheet for recipients of the Pfizer vaccine for covid-19 is here and there isn't a peep about it:

https://www.fda.gov/media/144414/download

Nor is there in its doc for healthcare providers, nor is it in the UK's NHS or Canadian equivalents.

An International Journal of Clinical Practice article on

https://onlinelibrary.wiley.com/doi/10.1111/ijcp.13795
"Informed consent disclosure to vaccine trial subjects of risk of COVID‐19 vaccines worsening clinical disease"

explains that the vaccine trials didn't meet medical ethics standards regarding fully informed consent since the issue of vaccine enhanced disease wasn't explained in a way they'd comprehend. The FDA's information doesn't even mention it, let alone explain it in the way people comprehend, which seems an obviously major violation of medical ethics. Its also doesn't make sense: since enough people will likely risk it anyway, but they should get that choice because even some experts wouldn't yet.

If they don't correct this soon, and chalk it up to an oversight in the rush to get this out the door: it risks a backlash in a few months if the public becomes generally aware of it, akin to the backlash after the Tuskegee study where participants weren't fully informed. They'll wonder: "If you didn't tell us about this risk, what else aren't you telling us, why should we trust it?". People can understand that trials are still ongoing: they won't understand not informing them of risks since it looks like a coverup, even if in theory they could have hunted through the FDA's more technical documents to find it.

Experts apparently don't agree on the magnitude of the risk: which is why its particularly important for it to be disclosed for public debate.

Media in countries hit hard by COVID-19 haven’t called attention to the issue to date. In contrast a Japanese paper quoted the director of the Japanese Society of Clinical Virology: “Concerns over ADE still remain. I am an elderly person myself, but if I were asked, I would say I don’t want to get a shot.” Elsewhere he explained: “In the past, a dengue vaccine proved effective in tests and was widely used, but then it worsened symptoms for people who were still getting infected.”. A leading professor of Immunology testified to Japan’s House of Representatives: “There’s no doubt that their effectiveness is quite high, but their safety is not guaranteed at all”.

Its also the case that many studies *do* see concerns over potential vaccine enhanced disease in this case. Severe covid isn't due to a lack of immune response: but a dysfunctional immune response. One study termed it an "uncoordinated" response. Will the response that occurs after the vaccine fades be a functional one, or an "uncoordinated" one? That paper suggests there is a risk that vaccines that only target the spike may be at risk of vaccine enhanced disease. Regardless, since they don't understand fully the broken response with severe covid-19, its unclear how they can yet be certain what the odds are the vaccine will be more or less likely to trigger a broken immune response that leads to severe illness. Hopefully not: the tests just haven't gone on long enough to demonstrate it.

The links to the various studies I mentioned are on BuildVaccineTrust.com where I put together information out of frustration that I didn't see it being addressed. Its focused on government and academic journal links and expert references for people to evaluate themselves.

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