Serum seeks emergency use approval for Oxford's coronavirus vaccine
Pune-based Serum Institute of India (SII) has sought emergency use authorization from Drugs Controller General of India (DCGI) for the coronavirus vaccine, which is developed by the University of Oxford and the British-pharma giant AstraZeneca, multiple reports said.
The Adar Poonawalla-run company has become the second firm after US-based Pfizer to seek approval of this nature.
Here are more details.
"Covishield is effective," SII informed DCGI
In the application, SII drew attention to four clinical studies of the vaccine, two of which happened in the UK and one each in Brazil and India.
The vaccine, dubbed Covishield here, is effective against severe COVID-19 infections, SII is learned to have told DCGI.
To note, UK and Bahrain gave the authorization to use the vaccine last week.
"Vaccine can be used to prevent disease in targeted population"
"Covishield is safe and well-tolerated and can be used effectively for prevention of COVID-19 in the targeted population. Thus, the benefit to risk ratio strongly supports the widespread use of Covishield," a source told PTI, citing SII's submission.
Committed to making India "aatmanirbhar": SII
Twelve batches of the vaccine have also been sent by SII to the Central Drugs Laboratory (CDL) in Kasauli for testing, a source informed HT.
The application, reportedly signed by Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, at SII, said the company is committed to fulfilling "Prime Minister's clarion call of vocal for local and making in India for the world."
Fulfilled our promise: Poonawalla
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.— Adar Poonawalla (@adarpoonawalla) December 7, 2020
Application received, government will begin process in few days
Now that SII has sent an application, the government will begin the regulatory process of emergency authorization approvals in a few days, reports IE. The government will also ponder over COVAXIN, the first indigenous vaccine being developed by Bharat Biotech.
"The Prime Minister has already said that a vaccine tested here will be ready in the next few weeks after regulatory approvals," sources disclosed.
SII's trials continued even after volunteer mentioned severe side-effects
Earlier, the government chose against stopping the trials of Covishield, even after a Chennai-based volunteer claimed the doses made him severely ill.
A 40-year-old participant sought Rs. 5 core compensation from SII alleging that he suffered from side-effects, including virtual neurological breakdown and impairment of cognitive functions.
In response, SII said it would seek Rs. 100 crore in damages, and rubbished his claims.
Pfizer's application has been forwarded to committee for scrutiny
Notably, SII's product fits well in India's picture as it can be stored between two and eight degrees Celsius.
The one developed by Pfizer needs to be stored in ultra-low temperatures. Nevertheless, DCGI has forwarded its application to the Subject Expert Committee (SEC) for detailed scrutiny.
The experts at SEC will submit their findings to DCGI, which will dictate the decision.