A neurology and neurophysiology specialist from Apollo Hospitals has labelled the Oxford Covidshield COVID-19 vaccine administered to a 40-year-old businessman in Chennai as responsible for his sudden neurological dysfunction. The doctor, whose name is being withheld, clinically examined his patient who was a participant in the third phase of the vaccine trial on November 11. His assessment that the participant developed acute neurological symptoms after receiving the shot has been cited in a legal notice sent to Pune-based Serum Institute of India (SII), who conducted the trial.
In his assessment, the doctor noted that, "The conglomerates of clinical, electro physiological and neuro psychological examinations, in the absence of any other diagnosable modalities, the neurological dysfunction suffered by the patient subsequent to his vaccination relates to immunogenicity of COVISHIELD-Covid19 vaccine."
The participant had been brought to the doctor for consultation after he was discharged from Sree Ramachandra Medical college and research institute (SRMC). He had been admitted there 10 days after receiving the shot, on October 11, after he exhibited psychological and neurological symptoms. He was, according to the doctor's affidavit, investigated for intracranial meningeal infection or encephalopathy. All tests relating to the infective process however returned as normal as did tests for limbic encephalitis, chemical, microbiological and immunological tests.
However, given the problem he continued to face the doctor concluded that his sudden symptoms and dysfunctions were caused by the vaccine.
The participant had sent a legal notice to SII last week, asking for Rs 5 crore as compensation for the health problem allegedly caused by the vaccine. He had further demanded that manufacture and distribution of the vaccine be immediately stopped.
SII however, continues to reiterate that the patient's condition is in no manner related to the vaccine.
In a statement on Tuesday, the company said, “The COVISHIELD vaccine is safe and immunogenic. The incident with the Chennai volunteer though highly unfortunate was in no way induced by the vaccine and Serum Institute of India is sympathetic with the volunteer's medical condition. However, we would like to clarify that all the requisite regulatory and ethical processes and guidelines were followed diligently and strictly. The concerned authorities were informed and the Principal Investigator, DSMB and the Ethics Committee independently cleared and reckoned it as a non-related issue to the vaccine trial. Post which we submitted all the reports and data related to the incident to the DCGI. It is only after we cleared all the required processes that we continued with the trials."
They have already filed a defamation suit of Rs 100 crore against the participant for allegedly attempting to malign their reputation.
"We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe," they said in their statement. "Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent therefore to safeguard the reputation of the company which is being unfairly maligned."