The Serum Institute of India (SII) on November 29 rejected the claims that a COVID-19 vaccine candidate to be manufactured by it had adverse effects on a participant during Phase 3 trial, and threatened to seek damages in "excess of Rs 100 crore" for "malicious" allegations.
The 40-year-old man who took part in the 'Covidshield' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the trial.
The participant was administered the vaccine at the Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.
“The allegations in the notice are malicious and misconceived. While the SII is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer," the SII said in a statement.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The volunteer is falsely laying the blame for his medial problems on the COVID-29 vaccine trial, the statement added.
The SII said the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent.
"In-spite of specifically being made aware of the same, he still chose to go public and malign the reputation of the company," the SII alleged.
The Pune-based vaccine manufacturer said the intention behind the spreading of such malicious information is an oblique pecuniary motive, and the company will seek damages in excess of 100 crore for the same and will defend such malicious claims.The vaccine maker has collaborated with Oxford University and AstraZeneca for making Covidshield, and is conducting trials in India.