Published 17:35 IST, November 29th 2020
Claim is malicious: SII issues statement over allegations of COVID vaccine's side-effects
SII has asserted that the volunteer is 'falsely laying blame' for his medical problems and has stated that it will seek damages in excess of Rs 100 crores
The Serum Institute of India (SII) - developers of Covishield - has shunned the allegations by a volunteer, who claimed that he suffered from neurological and psychological symptoms after receiving a dose of the COVID-19 vaccine. SII has asserted that the volunteer is 'falsely laying blame' for his medical problems. Moreover, the biotech firm has stated that it will seek damages in excess of Rs 100 crores for the same.
"The 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 made aware of the same, he still chose to go public & malign reputation of company," SII said in a statement on Sunday.
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 40-year-old trial candidate also sent a legal notice to the Drugs Controller General of India (DCGI), ICMR, Central Drugs Standard Control Organisation, CEO of AstraZeneca and the Vice-Chancellor of Sri Ramachandra Higher Education and Research. As per PTI, he was administered the shot of Covishield - which is being developed by Oxford-AstraZeneca and the Serum Institute of India - at Chennai's Sri Ramachandra Institute of Higher Education and Research (SRIHER).
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.
DCGI investigating causal links
Chief of the Epidemiology and Communicable Diseases (ECD) department of the ICMR, Dr Samiran Panda has informed that the DGCI is investigating the cause links. "Any hurried inquiry or inferences 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," PTI quoted Dr Panda.
Covishield's road to approval has been full of hurdles so far with the trials being stopped briefly by the DCGI in September. On September 11, the DCGI had directed the Serum Institute of India (SII) to halt the recruitment for phase 2 and phase 3 trials of the vaccine candidate as AstraZeneca had paused the trials in other countries due to an 'unexplained illness' in a particular study. The trials were restarted on September 15.
Moreover, questions have been raised over the vaccine's efficacy rate which was revealed on Monday. Oxford and AstraZeneca reported that their 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. They did not mention at the time, but later acknowledged, that a manufacturing issue had resulted in “a half dose of the vaccine being administered as the first dose” to some participants.
Some scientists have expressed concern about gaps in the data and the way the results were reported. Only 2,741 people received the half dose, making it hard to know if the effectiveness seen in the group is real or a statistical quirk. A total of 8,895 people received two full doses.
SII to seek emergency authorization for Covishield
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. Poonawalla has also shed light upon his discussions with Prime Minister Narendra Modi earlier today when he had visited the Serum Institute in Pune to take stock of the vaccine development personally. He also revealed that the Centre is likely to purchase nearly 300-400 million doses of the vaccine by July 2021. Moreover, he asserted that India will be prioritized first for the distribution countries followed by the African countries. PM Modi also deliberated upon the pros and cons of other COVID vaccine contenders, the logistical issues and the pricing issues, Poonawalla said.
Updated 20:43 IST, November 29th 2020