Covishield is 'safe and immunogenic', has no side effects, asserts Serum Institute of India

PUNE: Pune-based Serum Institute of India (SII) on Tuesday (December 01, 2020) claimed that Covishield - the anti-Covid-19 vaccine - being developed jointly by it is completely ''safe and immunogenic''. The company also categorically refuted claims that the Covishield anti-Covid-19 vaccine has side-effects.

"Covishield is safe & immunogenic," the Pune-based company said.

The clarification from the company came after a Chennai-based man claimed that he suffered neurological and psychological side effects taking a shot of Covid-19 vaccine Covishield during the human trial being conducted by Serum Institute of India's (SII).

Refuting the charge, the company said there was no correlation between the two. In a social media post, the institute asserted, "Covishield is safe & immunogenic, the incident with the Chennai volunteer no way induced by the vaccine."

“Incident with the Chennai volunteer no way induced by the vaccine. All regulatory and ethical processes and guidelines were followed. Principal Investigator, DSMB and Ethics Committee stated it was not related to the vaccine trial,” the Serum Institute of India said.

"While the Serum Institute of India is sympathetic to the volunteer`s medical condition, there is absolutely no correlation between the vaccine trial and the medical condition of the volunteer. The volunteer is falsely laying the blame for his medical problems on the COVID vaccine trial,'' the company said.

"The SII had stated that the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent. It is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive. The Serum Institute of India will seek damages in excess of Rs 100 crore for the same and will defend such malicious claims," the vaccine manufacturer said.

It added, “The legal notice was sent to safeguard the reputation of the company which is being unfairly maligned.”

SII is conducting clinical trials of AstraZeneca-Oxford's Covid-19 vaccine candidate in India. Currently, the phase-3 clinical trial of Covaxin is being conducted across India involving 26,000 participants. The vaccine will be produced in the Biosafety Level 3 production facility of the company.

The vaccine candidate, Covishield, is being developed by the UK's Oxford University and US pharma giant AstraZeneca. The SII is a manufacturing partner for the vaccine.