Be it the hospital, which is a clinical trial site for the vaccine, or the Drug Controller General of India and its Vaccine Data and Safety Monitoring Committee, or the sponsors ICMR and Serum Institute and its collaborators, or AstraZeneca and Oxford University. Until it's known if the serious adverse event is causally associated to the vaccine or not, we can not reach any decision.
Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, said, "Any hurried inquiry or inference is prone to be wrong".
A legal notice sent to the vaccine developer on behalf of the participant alleged that the man suffered serious neurological impairment after the under-trial vaccine was administered to him, according to a report in the Economic Times.
The volunteer, who signed the "Informed Consent Form" on September 29, 2020, was administered a test for antibodies against COVID-19 to rule out prior infection, and received a vaccine shot on October 1, reported The Hindu.
SII is now producing 50-60 million doses of the vaccine a month and its production will be scaled up to 100 million doses a month by January-February next year. "We are consulting another neurologist at the Apollo Hospital and his tests confirm dysfunction in his brain".
The patient's wife told The Hindu that her husband has not entirely recovered. "We will probe on this particular case reported now", he said.
The notice said the participant was discharged on October 26, with discharge summary stating that he had suffered "Acute Encephalopathy".
The notice further stated that the impact suffered by the man due to the vaccination "clearly proves" that the vaccine was not as safe as it is being made out to be and all the stakeholders are trying to hide the adverse effect that the vaccine has had on him.
Besides the compensation of Rs 5 crore, the man has also demanded that the testing, manufacturing and distribution of the vaccine be stopped immediately.
"The allegations in the notice are malicious and misconceived".
The volunteer is seeking compensation of 50 million rupees ($676,000).
Vaccine companies often argue that the adverse event may not be 'related, ' to the vaccine. Copies of his legal notice have also been sent to the Chief Executive of AstraZeneca in the United Kingdom, chief investigator of the Oxford trials and vice-chancellor of Ramachandra Institute.
"CDSCO must inform the public as to why the trial was not and has not been halted while it is contemplating the serious adverse event".
Poonawalla added, "Initially, our vaccine will be first distributed in India and then Covax countries in Africa".
This month, Bangladesh agreed to buy 30 million doses of the vaccine candidate from Serum Institute.
Earlier this week Mr Poonawalla told NDTV that a minimum of 100 million doses would be available by January and hundreds of million by the end of February.
They will apply to the Indian government for an emergency license in the next two weeks.