New Delhi: The Serum Institute of India (SII) on Sunday (November 29, 2020) rejected the claims by a trial participant who alleged serious side-effects of ‘Covishield’ coronavirus vaccine.
“The allegations in the notice are malicious and misconceived. While the Serum Institute of India is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer,” said SII in a statement.
They added that the volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial.
“The claim is malicious because 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,” stated the SII.
The world’s largest vaccine producer said it is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India said that they will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims.
Meanwhile, the latest reports say that the claim is being investigated by the Drugs Controller General of India (DGCI) and the institutional ethics committee at the trial site.
According to a PTI news agency report, the man from Tamil Nadu has alleged that the candidate vaccine was not safe and claimed that he suffered from serious side effects including a virtual neurological breakdown and impairment of cognitive functions.
In a legal notice to the SII and others, he has sought a compensation of Rs 5 crore and also sought cancelling approval for its testing, ‘manufacture and distribution’, failing which legal action would be taken.
The notice alleged that the man suffered acute encephalopathy, damage or disease that affects the brain, following vaccination and all tests confirmed that the setback in his health was due to the test vaccine.
PTI said that the Indian Council of Medical Research, one of the sponsors besides SII, and Sri Ramachandra Institute of Higher Education and Research, which administered the vaccine to the man, have been served with the notice.
The allegations come following Prime Minister’s visit to the SII in Pune to review the coronavirus vaccine development and manufacturing process on November 28.
(With inputs from PTI news agency)
Source: Zee News