Claim is malicious: SII issues statement over allegations of COVID vaccine's side-effects

Serum Institute of India (SII) - developers of Covishield - has shunned allegations by a volunteer, who claimed that he suffered from neurological and psychological symptoms after receiving a dose of COVID-19 vaccine. SII has asserted that volunteer is 'falsely laying blame' for his medical problems. Moreover, biotech firm has stated that it will seek dams in excess of Rs 100 crores for same. 

" claim is malicious because volunteer was specifically informed by medical team that complications he suffered were independent of vaccine trial he underwent. In spite of specifically being me aware of same, he still chose to go public & malign reputation of company," SII said in a statement on Sunday. 

A Chennai-based businessman h claimed that he suffered from severe neurological and psychological symptoms after being ministered with a dose of Oxford's COVID-19 vaccine candidate - Covishield. 40-year-old trial candidate also sent a legal tice to Drugs Controller General of India (DCGI), ICMR, Central Drugs Standard Control Organisation, CEO of AstraZeneca and Vice-Chancellor of Sri Ramachandra Higher Education and Research. As per PTI, he was ministered shot of Covishield - which is being developed by Oxford-AstraZeneca and Serum Institute of India - at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER).

volunteer sought Rs 5 crore compensation for allegedly suffering serious neurological and psychological symptoms after taking dose and has also demanded testing, manufacturing and distribution of vaccine candidate be stopped immediately. 

DCGI investigating causal links

Chief of Epidemiology and Communicable Diseases (ECD) department of ICMR, Dr Samiran Panda has informed that DGCI is investigating cause links. "Any hurried inquiry or inferences prone to be wrong. Both institutional ethics committee and DCGI are investigating causal links, if any, between verse events and investigational product, which is an anti-coronavirus vaccine," PTI quoted Dr Panda.

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Covishield's ro to approval has been full of hurdles so far with trials being stopped briefly by DCGI in September. On September 11, DCGI h directed Serum Institute of India (SII) to halt recruitment for phase 2 and phase 3 trials of vaccine candidate as AstraZeneca h paused trials in or countries due to an 'unexplained illness' in a particular study. trials were restarted on September 15. 

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Moreover, questions have been raised over vaccine's efficacy rate which was revealed on Monday. Oxford and AstraZeneca reported that ir vaccine appeared to be 62% effective in people who received two doses, and 90% effective when volunteers were given a half dose followed by a full dose. y did t mention at time, but later ackwledged, that a manufacturing issue h resulted in “a half dose of vaccine being ministered as first dose” to some participants.

Some scientists have expressed concern about gaps in data and way results were reported. Only 2,741 people received half dose, making it hard to kw if effectiveness seen in group is real or a statistical quirk. A total of 8,895 people received two full doses.

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SII to seek emergency authorization for Covishield

development comes as Serum Institute of India (SII) CEO, ar Poonawalla on Saturday stated that biotech firm is set to apply to Drugs Controller General of India (DCGI) for an emergency use license of its COVID-19 vaccine candidate - Covishield - in next two weeks. Poonawalla has also shed light upon his discussions with Prime Minister Narendra Modi earlier today when he h visited Serum Institute in Pune to take stock of vaccine development personally. He also revealed that Centre is likely to purchase nearly 300-400 million doses of vaccine by July 2021. Moreover, he asserted that India will be prioritized first for distribution countries followed by African countries. PM Modi also deliberated upon pros and cons of or COVID vaccine contenders, logistical issues and pricing issues, Poonawalla said. 

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