DCGI affirms no relation between Covishield & side-effects suffered by Chennai volunteer

Days after a volunteer alleged of experiencing side-effects after receiving a dose of Covishield, the Drug Controller General of India (DCGI) concluded that the COVID-19 vaccine had no connection to the 'serious advent event,' PTI sources reported. The DCGI's conclusion is based on the probe by an independent expert committee which also affirmed that the Rs 5 crore compensation sought should not be paid to the volunteer. The probing panel, constituted by the DCGI, comprised of a doctor from AIIMS, Post Graduate Institute of Medical Education and Research, Lady Hardinge Medical College and Maulana Azad Medical College. 

Health Ministry downplays allegations

Reacting to the allegations against Covishield, the Union Health Ministry on Tuesday, affirmed that any 'adverse event' will not affect the timeline of the vaccine. The Health Ministry highlighted that volunteers are made to sign a consent form before being part of any clinical trial in which they are apprised of all possible 'adverse events'.

"Data Safety Monitoring Board also monitors clinical trial from day to day basis & keeps an eye on adverse events & report it. Drug Controller General analyses all reports & finds out whether there's a one-to-one co-relation between adverse event & vaccination," Health Secretary Rajesh Bhushan said on Tuesday. 

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Covishield vaccine is safe and immunogenic: SII

In a statement released by the pharmaceutical company on Tuesday, the SII affirmed that their COVID vaccine candidate is safe and immunogenic. Addressing the serious concerns reported by a volunteer, Serum Institute of India said, '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.' 

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"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. It is only after we cleared all the required processes that we continued with the trials. We would want to assure everyone that the vaccine won’t be released for mass use unless it is proven immunogenic, and safe," the statement added. 

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A Chennai-based businessman had claimed that he suffered from 'severe neurological and psychological' symptoms after being administered with a dose of Oxford's COVID-19 vaccine candidate - Covishield. The volunteer sought Rs 5 crore compensation for allegedly suffering serious neurological and psychological symptoms after taking the dose and has also demanded the testing, manufacturing and distribution of the vaccine candidate be stopped immediately. The development comes as the Serum Institute of India (SII) CEO, Adar Poonawalla on Saturday stated that the biotech firm is set to apply to the Drugs Controller General of India (DCGI) for an emergency use license of its COVID-19 vaccine candidate - Covishield - in the next two weeks.

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