A Chennai neurologist opined that the 40-year-old man who volunteered for the Serum Institute of India’s covid vaccine trial developed acute neurological symptoms after receiving the injection. The participant had visited the doctor after being discharged from the hospital linked to the Covishield trial site.
“Clusters of clinical, electrophysiological and neuropsychological examinations, in the absence of other diagnosable modalities (despite various tests in SRMC), the neurological dysfunction suffered by (the participant) after their vaccination is related to the immunogenicity of Covishield covid-19 vaccine, “said Zaheer Ahmed Sayeed, a visiting neurologist at Apollo Hospitals, Chennai, in a statement on Nov. 21. The participant’s name was removed from the quote for privacy reasons.
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Mint has seen a copy of the statement, which is cited in the participant’s legal notice to the SII. Sayeed concluded that the vaccine caused the neurological damage after all other possibilities were eliminated through a battery of tests, including electroencephalogram (EEG), somatosensory evoked potentials (SSEP) test and neuropsychological evaluation. EEG, SSEP, and neuropsychological evaluations are used to examine neurological functions and the consequences of brain damage, brain disease, and serious mental illness. However, another doctor, seeking anonymity, said the letter shows that the neurologist’s qualified personal opinion is based on his diagnosis, and further evidence is needed to show that the vaccine is or is not a cause of the participant’s neurological problems. . He said post-vaccine neurological side effects are known to be rare after vaccines, but are considered safe if the benefits outweigh the risk.
For smallpox, post-vaccine encephalitis affects approximately three vaccinates per million primary vaccinates and 0.1 vaccinates per million repeat vaccinates, data from the 2009 National Institutes of Health-sponsored study showed.
On Tuesday, SII refuted the allegations saying that Covishield is safe and immunogenic, and did not cause the serious neurological adverse effect in the participant.
Read also Serum Institute denies claim of side effects, says Covishield ‘safe and immunogenic
“The incident with the Chennai volunteer, while very unfortunate, was in no way vaccine-induced, and the Serum Institute of India is sympathetic to the volunteer’s medical condition,” he said.
The conclusion that the vaccine had not caused “acute neuroencephalopathy” in the patient was made by Sri Ramachandra Medical College and Research Institute principal investigator Ramkrishnan, in addition to the Data and Safety Management Board and the ethics committee of the sites. trial independently, he added.
However, the SII did not disclose how the three entities reached the conclusion.
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