Oxford vaccine: Chennai man seeks Rs 5 crore for ‘illness’ after shot; DCGI begins probe

The 40-year-old man was administered the shot at Chennai’s Sri Ramachandra Institute of Higher Education and Research, one of the trial sites on October 1.

A Chennai-based business consultant has alleged that after he was administered a shot of Oxford-Astrazeneca vaccine candidate, he suffered serious neurological and psychological symptoms. The 40-year-old man was a volunteer for the third phase of the vaccine trial being conducted by Pune-based Serum Institute of India. Now, the man has sough Rs 5 crore compensation and immediate suspension of testing, manufacturing and distribution of the vaccine.

A law firm on his behalf has now sent a legal notice to Director General, ICMR, Drugs Controller General of India, Central Drugs Standard Control Organisation, CEO, Astra Zeneca UK, Professor Andrew Pollard, Chief Investigator, Oxford Vaccine Trial and Vice Chancellor of Sri Ramachandra Higher Education and Research, PTI reported.

The notice given on November 21 by the law firm said, “Our client states that he must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in future. He further states that he is still far from being all right and has to be under medical care for a long time to come. Therefore, for all the trauma he is undergoing and with an uncertain future in his health, he should be given a financial compensation of Rs 5 crores within two weeks from the receipt of this notice.”

The notice also said that testing, manufacturing and the distribution of the vaccine should also be stopped immediately, “failing which he has no other option except to take appropriate legal action against all the concerned parties, who would be made responsible for all the costs and consequences”.

The Drugs Controller General of India (DCGI) and the institutional ethics committee at the implementation site are investigating if the adverse event as claimed to have been suffered is related to the shot administered to him.

He was administered the shot at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites on October 1.

Talking to PTI, 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,” Dr Panda said.

The DCGI had on September 11 directed Serum Institute of India (SII) to suspend any new recruitment in phase 2 and 3 clinical trials of the Oxford Covid-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ‘’an unexplained illness’’ in a participant in the study.

However, on September 15 it permitted the Serum Institute of India to recommence the trial.

Oxford-Astrazeneca has recently announced 70.4 per cent efficacy of the vaccine candidate overall — 90 per cent efficacy in one dosing regimen when the vaccine was given as a half dose, followed by a full dose at least a month later, while another dosing regimen showed 62 per cent efficacy when given as two full doses at least one month apart.

Later, Astrazeneca admitted that the administration of half dose and then a full dose — which showed 90 per cent efficacy — has been actually a dosing error. As Astrazeneca is planning to run additional trials, Serum Institute of India has said there is yet no reason to worry as far as trials in India are going on. “The AstraZeneca-Oxford vaccine is safe and effective. Even the lowest efficacy results are at 60-70%, making it a viable vaccine against the virus. That said, varied age groups with different dosage forms will result in slight variations and efficacy. We must be patient and not panic,” Pune-based Serum Institute of India recently said in a statement.

Source: Hindustan Times

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