Serum Institute of India, the world’s largest vaccine manufacturer, on Tuesday, denied allegations that a COVID-19 trial volunteer suffered serious side effects from a vaccine developed by AstraZeneca and Oxford University, saying that the vaccine is safe and immunogenic.
“We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe,” it said in a blog.
Last week, a volunteer in Chennai claimed to have suffered serious neurological and psychological symptoms after taking the experimental shot and has sued the company along with others and a sought compensation of Rs 5 crore.
“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,” the Pune-based institute said.
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Serum is conducting trials of AstraZeneca’s vaccine in India as part of a manufacturing agreement.
“Taking into consideration the complexities and existing misnomers about vaccination and immunisation; the legal notice was sent (to the volunteer) therefore to safeguard the reputation of the company which is being unfairly maligned,” Serum said.
It said 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 (Drugs Controller General of India). It is only after we cleared all the required processes that we continued with the trials,” it added.
In response to claims made by the volunteer, Serum had on Sunday stated that the allegations were “malicious and misconceived”.