With the time frame being reduced for vaccine development, potential risks involved are much higher and the results of human trials are very important for its efficacy.
Phase 3 trial results with a large sample size would be effective in knowing the efficiency and safety of the vaccine.
Covishield vaccine being developed by the UK’s Oxford University with Serum Institute of India (SII) as a manufacturing partner for the vaccine is one of the strongest candidates in India right now, but it has been embroiled in some controversies lately.
While an announcement by AstraZeneca and Oxford showed their shot was 70% effective on average in a late-stage study and as the world celebrated hopes of an effective Covid-19 vaccine to be available soon, it was reported that it was actually a stroke of good luck.
From an ‘error’ during the trial stage of some participants being given a half dose instead of a full one which spiked up efficacy rates incorrectly, to neurological complications cases which sounded off an alarm and added doubts about the way AstraZeneca and Oxford have been conducting these trials.
Just a week ago, a 40-year-old business consultant, who was a volunteer for the Covidshield vaccine, has sought Rs 5 crore compensation for the neurological complications he developed after being administered the test dose.
Addressing the concerns related to the serious adverse events reported by a volunteer in Chennai, SII claimed there was no correlation between the two.
SII refuted the allegations saying that Covishield is safe and immunogenic, and did not cause the neurological serious adverse effect in the participant
But according to Mint Report, “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 revelation has flagged the lack of transparency in the entire process.
“The conglomerates of clinical, electrophysiological and neuropsychological examinations, in the absence of other diagnosable modalities (despite several varieties 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 the quote for privacy.
While many medical experts have also questioned the company’s way of handling the trials.
SII clarified that the vaccine won’t be released for mass usage unless it is proven immunogenic, and safe. “The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned: Serum Institute of India,” said SII.
It must be noted that vaccine development is a long process with multiple stages and most important of all is human trials and in any trial fast-tracking the process could lead to severe consequences for the safety and the health of people.