Health Ministry reacts to claims against Covishield: 'Won't affect vaccine timeline'

Even as the Serum Institute of India (SII) issued a statement asserting that its COVID-19 vaccine candidate is completely safe, the Union Health Ministry on Tuesday, affirmed that any 'adverse event' will not affect the timeline of the vaccine. The Health Ministry was referring to the allegations of a 40-year-old Chennai businessman, who has claimed of suffering from 'neurological and psychological symptoms' after receiving a dose of Covishield. 

The Health Ministry also 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'. Addressing a press conference on Tuesday, ICMR DG Dr Balram Bhargava pointed out that it is the role of the 'regulator' to investigate and conclude if there is any causal link between the event and the intervention. As per PTI, Drugs Controller General of India (DCGI) has taken note of the incident and is ascertaining, if there is any causal link between the symptoms and the vaccine candidate. 

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"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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Providing an update on India's COVID-19 tally, the Health Ministry also highlighted that the cumulative positivity rate has decreased in India from 7.15% to 6.69% during November 11- December 1. It also said that the number of recoveries has been more than the number of new COVID-19 cases in the mentioned period. "Average daily positivity rate last week was 3.72%. Among all the big nations in the world, cases per million in India (at 211 cases/mn ) are the lowest. Last 7 days trends show that European nations are witnessing a surge in COVID cases," the Health Secretary said. 

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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.