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 the Serum Institute of India in a statement.
They added that the volunteer is falsely laying the blame for his medical problems on the coronavirus 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.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said the causal link, if any, of the serious adverse events with the investigational product is objectively assessed in any clinical trial following a pre-defined scientific pathway and within a stipulated period.
"Any hurried inquiry or inference is prone to be wrong. Both the institutional ethics committee and the DCGI are investigating the causal links, if any, between the adverse events and investigational product, which is an anti-coronavirus vaccine. A preliminary assessment has not indicated any causal link as yet," PTI news agency quoted Dr Panda as saying.
According to a PTI report, the Chennai man has alleged that the candidate COVID-19 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. Hours after PM Modi's visit, SII's CEO Adar Poonawalla said that his company will seek permission for emergency use authorization of 'Covishield' in the next two weeks.
(With inputs from PTI news agency)