A 40-year old business consultant in India, who volunteered to be a participant in clinical trials of the experimental COVID-19 vaccine (Covishield) created by AstraZeneca and Oxford University is suing Serum Institute of India (SII), which is producing the vaccine in India, for 50 million rupees ($680,000) after he developed acute encephalopathy (brain dysfunction) within 10 days of vaccination. According to Science Magazine, Serum Institute has denied the vaccine caused the encephalopathy and is countersuing the trial volunteer for up to 1 billion rupees (over $1 million) for “reputational damage.”1
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.”2
The Hindu reported that the Covishield trial volunteer was enrolled for the third phase of the human trial at India’s Sri Ramachandra Institute of Higher Education and Research, Chennai. His wife said that the multiple “categorical assertions”—made in the participant information sheet—that the vaccine was safe and did not cause serious reactions had “convinced him” that it was “safe.” He signed the ‘Informed Consent Form’ on Sept. 29, 2020 and, after being tested for antibodies against COVID-19 to rule out prior infection, he was vaccinated on Oct. 1.3
The Hindu reported:
Ten days after the shot, he complained of a severe headache, followed by vomiting that confined him to the bed for the rest of the day. His wife, according to the legal notice, said there was a total “behavioural change” in her husband and he seemed unaware of his surroundings. “He showed irritation towards light and sound, and was resisting any effort to make him get up from bed,” the notice states. He was taken in an ambulance to the emergency ward of the Sri Ramachandra Medical College and Hospital.
Serum Institute of India Denies AstraZeneca/Oxford’s COVID-19 Vaccine Caused Brain Damage and Countersues Now Disabled Trial Participant
In a Nov. 29 statement, SII acknowledged that the volunteer did receive the AstraZeneca/Oxford COVID-19 vaccine and not a placebo but stated that, “there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer. He’s falsely laying blame for his medical problems on trial. It is evident that the intention behind spreading of such malicious information is an oblique pecuniary motive.”4
Upon discharge from the hospital, the summary stated that the patient had been treated for an “acute encephalopathy.” It was also noted that he had a Vitamin B12 and Vitamin D deficiency, as well as a “probable connective tissue disorder.”5 The hospital’s institutional ethics committee reportedly concluded that the acute encephalopathy was not caused by the vaccine, however further details about the case have not been released to the public by SII or the government.6 7
After Severe Adverse Event, Serum Institute Failed to Pause Clinical Trial of AstraZeneca/Oxford COVID-19 Vaccine
The AstraZeneca/Oxford COVID-19 vaccine trial participant has alleged that during his month-long severe adverse event following receipt of Covishield, SII and government officials in India did not get in touch with him for a follow-up, which his attorneys reportedly said is against standards of the World Health Organization (WHO). Apart from financial compensation, the patient has sought to stop the vaccine from being licensed, maintaining that, “the testing, manufacturing and the distribution of the vaccine should also be stopped immediately.”8
Science Magazine quoted Thekkekara Jacob John, a retired virologist, as saying that “Done properly, the investigations into a serious adverse event could have been done in just three days. If they were not sure, the study should have been halted and the public informed.”9
Serum Institute is producing one billion doses of Covishield for distribution in India and CEO Adar Poonwalla told reporters during a Nov. 28, 2020 press briefing that there were “zero hospitalizations’ among Covishield trial participants. He said:10
In a world today, everyone is questioning vaccines and vaccine hesitancy, you know [and] we should collaborate together and the media, manufacturers, government of India, and everybody to send the right messaging out and not spread any panic or negative news unnecessarily without getting down to the facts. It’s only when the facts have been confirmed should we send out any messages because we don’t want to build doubt in the minds of people today, especially in a time of pandemic, and have a situation where vaccines are available, you know, but some people are hesitant to take them because they’re a bit unsure or skeptical on the safety, etc. etc. So I feel that we should only put out messages that are properly confirmed, you know, in terms of the fact checking from the Ministry of Health and the manufacturers before we put anything out and create any negative panic around vaccines because we need to project the power of vaccines and how they can save and protect our lives and our children. Thank you.
Astra Zeneca/Oxford Temporarily Halt COVID-19 Vaccine Trial in September After Severe Neurological Reaction in UK Trial Volunteer
Several months ago, on Sept. 8, 2020, AstraZeneca announced it had voluntarily suspended Phase 3 clinical testing of Covishield after a female participant in a United Kingdom trial developed transverse myelitis (inflammation of the spinal cord) after being injected with the vaccine.11 Four days later, AstraZeneca released a statement that it was resuming the trial in the U.K. after confirmation by the Medicines Health Regulatory Authority (MHRA) (Britain’s equivalent of the U.S. Food and Drug Administration) that it was safe to do so.12 No further details were provided.
Transverse myelitis involves inflammation of the spinal cord, which carries signals to and from the brain through nerves that extend from each side of the spinal cord and connect to nerves elsewhere in the body. Symptoms of transverse myelitis include pain that can be sharp or blunt and may shoot down arms and legs or wrap around the trunk or chest; sensory problems such as tingling, numbness, pricking, coldness, burning and sensitivity to touch or temperature; weakness in the legs and possibly the arms causing loss of balance, difficulty walking, and loss of function, which may develop into paralysis; bladder and bowel problems such as constipation, incontinence, or frequent need to urinate; and sexual dysfunction. These problems may develop suddenly over a period of hours, or over days or weeks and healing can take months to year or result in permanent damage.13
The Astra Zeneca/Oxford University COVID-19 vaccine (ChAdOx1 nCoV-19 or Covishield) is a genetically engineered viral-vectored vaccine using a replication-deficient chimpanzee adenovirus that infects and causes respiratory symptoms in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. Covishield vaccine induces production of the coronavirus surface spike protein, priming the immune system to prevent COVID-19 disease.14
As reported in The Vaccine Reaction, preliminary results of Phase 1 and Phase 2 Covishield trials were published in The Lancet in July 2020 and up to 70 percent of participants experienced adverse reactions:15
Fatigue and headache were the most commonly reported systemic reactions. Fatigue was reported in the ChAdOx1 nCoV-19 group by 70 percent of the participants, who were not give paracetamol [acetaminophen/Tylenol] prior to vaccination, and in the MenACWY group by 48 percent of the participants without paracetamol. Headaches were reported in the ChAdOx1 nCoV-19 group by 68 percent of the participants without paracetamol and 61 percent with paracetamol and in the MenACWY group by 41 percent of the participants without paracetamol and 37 percent of the participants with paracetamol.
Other systemic adverse reactions were common in the ChAdOx1 nCoV-19 vaccine group: muscle ache—60 percent, malaise—61 percent, chills—56 percent, and feeling feverish—51 percent. In the ChAdOx1 nCoV-19 vaccine group, 18 percent of participants without paracetamol and 16 percent of participants with paracetamol reported a temperature of at least 100.4°F, and two percent of patients without paracetamol had a temperature of at least 102.2°F. In comparison, less than one percent of those receiving MenACWY reported a fever of at least 100.4°F, none of whom were receiving prophylactic paracetamol.
Encephalopathy a Long Recognized Vaccine Reaction
According to the National Institute of Neurological Disorders and Stroke, encephalopathy is a “diffuse disease of the brain that alters brain function or structure” and is marked by an altered mental state.16 Acute encephalopathy can develop after viral or bacterial infections, exposure to toxins (solvents drugs, radiation, paints, certain chemicals and metals), physical trauma, metabolic or mitochondrial dysfunction, lack of oxygen or blood flow to the brain, brain tumor, or vaccination and can occur alone or in conjunction with or after brain inflammation (encephalitis).
Encephalitis, encephalopathy and Acute Disseminated Encephalomyelitis (ADEM) have long been recognized as severe complications of different types of vaccines that can develop within days or weeks of vaccination.17 18 19 20 21 22 23 24 25 26 27 28 29 Symptoms of encephalopathy or encephalitis, including autoimmune encephalitis when the body’s immune system mistakenly attacks brain cells,30 31 can include:
- seizures (involuntary twitching, jerking);
- loss of memory and cognitive ability;
- inability to concentrate;
- muscle weakness;
- trouble with balance, swallowing, speaking or seeing;
- personality and behavior changes.
Encephalopathy, as well as encephalitis and ADEM, are adverse health outcomes listed on the Vaccine Injury Table of the federal Vaccine Injury Compensation Program (VICP) created under the National Childhood Vaccine Injury Act of 1986.32
Reporting Vaccine Adverse Events to VAERS
All adverse events following vaccination, especially those involving trips to the emergency room, hospitalization, permanent injury or death, by federal law are supposed to be reported to the federal Vaccine Adverse Event Reporting System (VAERS) operated by the U.S. Food and Drug Administration (FDA) the Centers for Disease Control and Prevention (CDC).33 One federally funded report published in 2011 found that less than one percent of vaccine adverse events are reported to VAERS.34
If a doctor, nurse or other vaccine provider refuses to make a vaccine reaction report to VAERS, the person who was vaccinated or a parent or other family member may make the report.35
Click here to view References:
1 Kumar S. ‘Malicious and misconceived.’ Indian vaccine producer hits back at complaint from trial volunteer. Science Magazine Dec. 2, 2020.
2 Omjasvin MD. Alleging side-effects from Covishield vaccine trials, Chennai-based volunteer seeks Rs5 crore compensation. New Indian Express Nov. 29, 2020.
3 Desikan S, Koshy J. ‘Covishield’ vaccine volunteer sues Serum Institute of India, Oxford Group over ‘adverse reaction.” The Hindu Nov. 28, 2020.
4 Omjasvin MD. Alleging side-effects from Covishield vaccine trials, Chennai-based volunteer seeks Rs5 crore compensation. New Indian Express Nov. 29, 2020.
5 Desikan S, Koshy J. ‘Covishield’ vaccine volunteer sues Serum Institute of India, Oxford Group over ‘adverse reaction.” The Hindu Nov. 28, 2020.
7 Kumar S. ‘Malicious and misconceived.’ Indian vaccine producer hits back at complaint from trial volunteer. Science Magazine Dec. 2, 2020.
8 Omjasvin MD. Alleging side-effects from Covishield vaccine trials, Chennai-based volunteer seeks Rs5 crore compensation. New Indian Express Nov. 29, 2020.
9 Kumar S. ‘Malicious and misconceived.’ Indian vaccine producer hits back at complaint from trial volunteer. Science Magazine Dec. 2, 2020.
10 YouTube. Serum Institute of India (SII) CEO Briefs Media on PM Modi’s Review of Covishield, Assures ‘India to Get Vaccine Before Europe.’ Nov. 28, 2020.
11 Feuerstein A., Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says. STAT News Sept. 9, 2020.
12 AstraZeneca COVID-19 vaccine AZD1222 clinical trials resumed in the UK. Sept. 12, 2020.
13 University of San Francisco. Transverse Myelitis USFC Health Dec. 22, 2019.
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15 Cáceres B. AstraZeneca Halts, Resumes COVID-19 Vaccine Trial After Serious Neurological Event. The Vaccine Reaction Sept. 14, 2020.
16 National Institute of Neurological Disorders and Stroke. Encephalopathy Information Page. Mar. 27, 2019.
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21 Institute of Medicine. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Washington, D.C. The National Academies Press 1994.
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24 Ward KN, Bryan NJ, Andrew NJ et al. Risk of Serious Neurologic Disease After Immunization of Young Children in Britain and Ireland. Pediatrics 2007; 120(2): 314-321.
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27 Rogalewski , Kraus J et al. Improvement of advanced postvaccinal demyelinating encephalitis due to plasmapheresis. Neuropsychiatr Dis Treat 2007; 3(6): 997-991.
28 Stone MJ, Hawkins CP. A Medical Overview of Encephalitis. Neuropsychol Rehabil 2007; 17(4-5): 429-449.
29 Pellegrino P, Carnovale C, Perrone V et al. Acute Disseminated Encephalomyelitis Onset: Evaluation Based on Vaccine Adverse Events Reporting System. PLOS One Oct. 18, 2013.
30 National Institutes of Health. Autoimmune Encephalitis. Genetic and Rare Diseases Information Center Oct. 26 2017.
31 Wang H. Anti-NMDA Receptor Encephalitis and Vaccination. Int J Mol Sci 2017; 18(1): 193.
32 HRSA. Encephalopathy, Encephalitis, Acute Dissemination Encephalomyelitis. Vaccine Injury Compensation Program Vaccine Injury Table. Mar. 21, 2017.
33 DHHS. Vaccine Adverse Event Reporting System (VAERS). Two Ways to Submit an Online Report to VAERS. Also Online VAERS Reporting Demonstration. July 2017.
34 Harvard Pilgrim Health Care, Inc. Electronic System for Public Health Vaccine Adverse Event Reporting System. AHRQ 2011.
35 National Vaccine Information Center. Vaccine Reporting Systems: You Have Options!