Volunteer’s doc blames SII vaccine for neuro disorder2 min read . Updated: 02 Dec 2020, 09:21 AM IST
- But Serum Institute denies its Covishield shot caused adverse effect in 40-year-old
A Chennai-based neurologist has opined that the 40-year-old who volunteered for the Serum Institute of India’s covid vaccine trial developed acute neurological symptoms after receiving the shot. The participant had visited the doctor after he was discharged from the hospital linked to the Covishield trial site.
“The conglomerates of clinical, electro physiological and neuropsychological examinations, in the absence of other diagnosable modalities (despite several variety of tests at SRMC), the neurological dysfunction suffered by (the participant) subsequent to his vaccination relates to immunogenicity of Covishield covid-19 vaccine," Zaheer Ahmed Sayeed, a visiting neurologist at Apollo Hospitals, Chennai, said in a 21 November declaration. The participant’s name was removed from quote for privacy.
Mint has seen a copy of the declaration, which is cited in the participant’s legal notice to SII. Sayeed concluded that the vaccine caused the neurological damage after all other possibilities were eliminated through a battery of tests, including electroencephalogram (EEG), somato sensory evoked potential (SSEP) test and neuropsychological assessment. EEG, SSEP and neuropsychological assessments are used to examine neurological functions and consequences of brain damage, brain disease and severe mental illness. However, another physician, seeking anonymity, said the letter shows the qualified personal opinion of the neurologist is based on his diagnosis, and more evidence is needed to prove that the vaccine is or not a cause for the neurological issues of the participant. He said post-vaccine neurological side-effects are known to be uncommon after vaccinations, but is considered safe if the benefits outweigh the risk .
For smallpox, post-vaccine encephalitis affects about three vaccinees per million primary vaccinees, and 0.1 vaccinees per million repeat vaccinees, data from the National Institutes of Health-sponsored study of 2009 showed.
On Tuesday, SII refuted the allegations saying that Covishield is safe and immunogenic, and did not cause the neurological serious adverse effect in the participant.
“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," it said.
The conclusion that the vaccine had not caused the “acute neuro encephalopathy" in the patient was made by the principal investigator of Sri Ramachandra Medical College and Research Institute, Ramkrishnan, besides the Data and Safety Management Board and the ethics committee of the trial sites independently, it added.
However, SII did not reveal how the three entities reached the conclusion.