New Delhi: The world’s largest vaccine maker, the Serum Institute of India, on Tuesday dismissed allegations that Kovid-19 trial volunteers suffered serious side effects from a vaccine developed by AstraZeneca and the University of Oxford.
“We want to assure everyone that the vaccine will not be released for mass use unless proven to be immunogenic and safe,” it said in the blog.
Last week, a volunteer in Chennai claimed to have suffered serious neurological and psychiatric symptoms after taking a clinical blow and has sued the company along with others and paid Rs 5 crore.
“The incident with the Chennai volunteers, although highly unfortunate, was not triggered by the vaccine and the sympathy of the medical condition of the Serum Institute of India volunteers,” the Pune-based agency said.
As part of a production agreement, Serum is conducting AstraZeneca vaccine trials in India.
“Considering the complexities of vaccination and immunization and the prevailing misnomer; legal notice has been sent (to volunteers) to safeguard the reputation of an unfairly corrupted company,” said Serum.
It said all necessary regulatory and ethical processes and guidelines were diligently and strictly followed.
“The concerned authorities were informed and the Principal Inspector General, the DSMB and the Ethics Committee considered the issue of the vaccine trial as an independent clearance.
“We have submitted the post, all the reports and data related to the incident to the DCGI (Drugs Controller General of India). We proceeded with the experiments only after we had cleared all the required processes,” it said.
In response to the volunteers’ claims, Serum said Sunday the allegations were “malicious and misconceived.”

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