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According to an article on thevaccinereaction.org, a 40-year old vaccine trial participant in India experienced acute encephalopathy after participating in a COVID-19 vaccine trial. The article reports:

Hospitalized for 15 days, including eight days in the intensive care unit, the acute encephalopathy left the vaccine trial volunteer “totally disoriented,” and unable to recognize close relatives. According to the New Indian Express, the law firm representing the Covishield trial volunteer said, “our client’s wife states that he is still not stable, has severe mood swings, has problems comprehending and focusing on things, and is finding it difficult to even do simple routine things like making online payments, leave alone focusing on work-related matters.”

The article also reports that the Serum Institute of India (SII) denies any connection between the volunteer's participation in the study and his subsequent condition, and that the study was not halted or even paused when the adverse condition emerged.

The source for this report is (as its domain name suggests) a project of the National Vaccine Information Center, a noted anti-vaccine group, which raises reasonable questions about the reliability of the report. I have not been able to find any reporting on this case in more reliable sources.

What (if anything) is known about this case?

Fizz
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mweiss
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    The site referenced is an arm of mercola.com, a website known to spread [conspiracy theories](https://articles.mercola.com/sites/articles/archive/2020/06/13/bill-gates-agenda.aspx), and is about a current event. It doesn't seem like a notable source, and the matter is still under investigation. – jdunlop Dec 08 '20 at 03:10
  • @jdunlop right — my question is whether anyone has a more reliable source on what, if anything, is true about this story. – mweiss Dec 08 '20 at 03:12
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    The article you link links to a [sciencemag article](https://www.sciencemag.org/news/2020/12/malicious-and-misconceived-indian-vaccine-producer-hits-back-complaint-trial-volunteer). ScienceMag is broadly reliable, and indicates that the simple answer is "yes, the participant suffered acute encephalopathy", but that not only the SII but an independent ethics board determined that there was no connection. The rest of the details are unclear because the case is before the courts. (This is generally why current-events questions are closed.) – jdunlop Dec 08 '20 at 03:48
  • Particularly relevant is whether or not the participant received a placebo. – Rebecca J. Stones Dec 08 '20 at 09:42
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    @jdunlop disproving quacks and conspiracy theorists is the main purpose of skeptics stack exchange. So "this website is known to spread conspiracy theories" isn't a reason not to address it here. Quite the contrary. The only thing that's relevant is if [it's a claim which reaches a lot of people](https://skeptics.meta.stackexchange.com/questions/864/faq-must-all-questions-be-notable) and is presented in a way that people could believe it. – Philipp Dec 08 '20 at 10:17
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    @RebeccaJ.Stones - the linked sciencemag article (from the initial link) makes it clear that the plaintiff did receive the actual vaccine, not a placebo. – jdunlop Dec 08 '20 at 10:22
  • It would be helpful to know what the incidence of acute encephalopathy is for people in her cohort. – Daniel R Hicks Dec 08 '20 at 16:38
  • @jdunlop THat reads like an answer to me. – DJClayworth Dec 08 '20 at 17:06
  • Not an answer, but the following blog entry is relevant, I think. Remember that the vaccine doesn't protect you from everything else. https://blogs.sciencemag.org/pipeline/archives/2020/12/04/get-ready-for-false-side-effects – Eric S Dec 08 '20 at 17:15
  • @DJClayworth: maybe... to the extent that corruption didn't affect the findings... https://www.bmj.com/campaign/corruption-healthcare "In a first, the then health minister of India acknowledged rampant corruption in medical regulatory bodies [...] " – Fizz Dec 08 '20 at 19:20
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    It should be noted that this patient is apparently from the same area in India where a "mystery illness" has sickened many individuals: https://www.usatoday.com/story/news/health/2020/12/08/india-mystery-illness-nickel-and-lead-blood-hospitalized/6490587002/ – Daniel R Hicks Dec 09 '20 at 01:01
  • If someone who didn't take part in the trial developed encephalopathy, would that then mean that not getting the vaccine causes encephalopathy? Correlation != causation. – Jerome Viveiros Dec 09 '20 at 07:59
  • @JeromeViveiros Obviously that's true. But I would expect (perhaps incorrectly?) that when someone develops encephalopathy, typically it is possible to identify a proximate cause (infection, anoxia, metabolic problems, toxins, drugs, physiologic changes, trauma...). I would think that one of the ways you rule out a vaccine-induced reaction would be to offer an alternative explanation. The fact that no such alternative explanation was provided in this case strikes me as odd. But I am not a doctor, so perhaps this is naive of me. Is "encephalopathy of unknown origin" a common thing? – mweiss Dec 09 '20 at 18:32
  • @mweiss - Did you read the USA Today piece I linked above? – Daniel R Hicks Dec 10 '20 at 01:33
  • @DanielRHicks yes, I did. I don’t know enough to know whether the symptoms described in that article are consistent with a diagnosis of encephalopathy. Are they? If not, it seems unlikely to be related to this case. – mweiss Dec 10 '20 at 01:37
  • @mweiss - After a quick Google: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4064184/ – Daniel R Hicks Dec 10 '20 at 01:40
  • FYI: India just approved their own home-made vaccine, with hardly anything in the way of published data. https://www.bbc.com/news/world-asia-india-55526123 – Fizz Jan 04 '21 at 14:25

1 Answers1

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On the suggestion of a commenter:

Yes, They Did, But.

The question as asked in the title is "did a participant in the vaccine trial develop acute encephalopathy?" In the original posted article, there was a link to a sciencemag article that stated it fairly definitively:

The trial participant, a 40-year-old business consultant from Chennai, sent SII a legal notice on 21 November claiming he developed a severe neurological condition on 11 October, 10 days after receiving his first vaccine dose. He spent 15 days in hospital, including 8 days in intensive care, suffering from acute neuro-encephalopathy that left him “totally disoriented,” according to the complaint, so much so that he could no longer recognize close relatives. He is doing much better now but still has not fully recovered, his wife has told reporters.

Moreover:

...[T]he trial’s principal investigator, S. R. Ramakrishnan of the Sri Ramachandra Institute of Higher Education and Research has acknowledged in interviews that the subject fell seriously ill, and that he did receive the study vaccine, not a placebo.

However:

Based on a radiological examination of his brain, Ramakrishnan determined his illness was not a result of the vaccination, he reportedly told The Straits Times. A local ethics committee agreed with that assessment, Ramakrishnan said.

Also, from separate reporting (emphasis mine):

"The causal link is objectively assessed at three levels – by the IEC and the DSMB and the DCGI. If someone isn’t satisfied with the assessments of all three regulators, a medico-legal process is the only way to go. These complexities are also explained in the consent form, where it is also clarified that the IEC, DSMB and DCGI will determine the outcomes of any outliers," explains Dr Samiran Panda, Director of the Indian Council of Medical Research (ICMR)-National AIDS Research Institute (NARI) — the organisation tasked with conducting the WHO Solidarity Trial in India. "The DCGI ultimately decides whether to attribute a side effect to the investigational product, or refute it. In this particular case, the causal link was not found and established," Dr Panda added.

So, a participant who received the vaccine developed an encephalopathy. The preliminary conclusion of multiple agents working in a supervisory capacity over the vaccine trial was that the vaccine was not the cause of the injury. Due to the impossibility of definitively proving a negative, and (from the second article) what sounds like systemic transparency issues with the entire development processes, legal proceedings have begun, with suits and countersuits, muddying the waters a bit.

Editorial note: This is akin to the perennial "vaccines cause autism" debate. Proving that no vaccine has ever triggered autism in any recipient is effectively impossible, because individual biochemistries can always have unexpected interactions. The same is true here. So aside from the legal embroilments, one cannot state definitively that the vaccine didn't cause the encephalopathy. Moreover, even if an alternative cause is found, one cannot rule out the possibility that the vaccine aided or exacerbated it.

However, with multiple reportedly independent assessments suggesting that they see no causal link, it is probable that the injury is independent of the patient's participation in the vaccine trial.

jdunlop
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  • Well, if you're gonna provide editorial notes for context, add that India has one of the most corrupt medical systems, at all levels https://www.bmj.com/campaign/corruption-healthcare (Aside: corruption [may](https://apnews.com/article/china-virus-testing-secret-deals-firms-312f4a953e0264a3645219a08c62a0ad) also have had something to do with China's response to the Covid-19 outbreak.) – Fizz Dec 08 '20 at 21:43
  • More details on regulatory-level medical corruption in India here: https://indianexpress.com/article/india/politics/mci-corrupt-clinical-trials-body-a-snake-pit-harsh-vardhan/ And drug companies [regularly bribe](https://blogs.sciencemag.org/pipeline/archives/2012/09/17/pharma_sales_corruption_in_india_and_how) doctors in India as they [do in China](https://en.wikipedia.org/wiki/GSK_China_scandal). – Fizz Dec 08 '20 at 21:51
  • The funky sentence in the reporting is actually **"Based on a radiological examination of his brain, Ramakrishnan determined his illness was not a result of the vaccination."** So I'm guessing they know the actual cause, but don't reveal it. Because how can otherwise a "radiological examination" exclude that the cause was a biological agent (of whatever kind--plenty of bacteria and some viruses cause encephalitis). – Fizz Dec 09 '20 at 01:39
  • Also: "SII agreed that “there is **absolutely no correlation** with the vaccine trial and the medical condition of the volunteer,” but did not provide any details." You'd think the CEO of company that runs medical trials (even in India) would know the difference between correlation and causation. After all, if there were no correlation whatsoever, this would not be in the press. – Fizz Dec 09 '20 at 01:47
  • My guess based on the claim of conclusion by radiography is that this is cysticercosis. – Fizz Dec 09 '20 at 01:55
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    @Fizz That "funky sentence" was what made me wonder about this story in the first place -- see my comment to Jerome Viveiros under the OP – mweiss Dec 09 '20 at 18:34