Serum Institute of India (SII) has sought authorisation from the Drug Controller General of India (DCGI) for emergency use of the Covid19 vaccine, which has been developed by AstraZeneca and Oxford University.
This has been confirmed by an official source, said a media report.
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According to the report, the Serum Institute of India is the second company in the country which has applied for Emergency Use Authorisation (EUA) of the Covid19 vaccine.
Also read: Serum Institute of India to seek emergency use authorization for Covid-19 vaccine
Earlier, the multinational pharmaceutical company, Pfizer received EUA in the United Kingdom and approached the Indian regulator for the same.
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The Serum Institute of India has collaborated with AstraZeneca and Oxford University to produce and distribute their Covid19 vaccine candidate in India and other low and middle-income countries.
It has been reported that the vaccine is said to be best suited for Indian conditions in terms of storage and deployment.
However, a volunteer, who participated in a trial at a Chennai hospital, complained of serious adverse events and linked it to the vaccination.
This allegation was levelled by the family and lawyers of the volunteer.
A legal notice was also served on behalf of the volunteer seeking compensation of Rs 5 crore.
They also sought the discontinuation of the human trial.
But SII refuted the allegations and said the volunteer’s medical condition was not linked to the trial of the vaccine.
The company lodged a counter-claim and sought a compensation of Rs 100 crore for the damages caused due to the allegations.