India’s Serum Institute seeks emergency use nod for Covid-19 vaccine
Srinagar, India, Dec 7 (efe-epa).- The Serum Institute of India, the world’s largest vaccine manufacturer by volume, on Monday said it had sought emergency use authorization for the coronavirus vaccine it is developing with the University of Oxford and British drugmaker AstraZeneca.
“As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorization for the first made-in-India vaccine, COVISHIELD. This will save countless lives,” Adar Poonawala, who leads the institute, said in a tweet.
The SII has applied to the Drugs Controller General of India, citing emergency medical needs triggered by the pandemic and the interest of the public at large for the emergency use authorization for the Covishield vaccine.
The Pune-based pharma is the second firm after American Pfizer to have applied for a similar authorization from the drug regulator for its coronavirus vaccine in India.
The United Kingdom became the first country to roll out the Pfizer Covid-19 vaccine last week. Bahrain announced that it had granted a EUA for the two-dose vaccine made by the pharma company and its partners.
Poonawalla had late last month indicated that the serum institute would be able to market 300-400 million doses by July 2021.
Covishield vaccine is logistically feasible for distribution in India since it could be stored between two to eight degrees Celsius unlike Pfizer’s that needs minus 70 degrees for storage and transportation.
He stressed that the trials were more than enough for the efficacy and said his pharma was now considering the trials on group less than 18 years of age.
The vaccine, according to Poonawalla, has drawn an immune response even in the highly vulnerable elderly persons.
“This vaccine is a very good one. What we found with Covishield in its global trial is there were zero hospitalisations, which means even if you do get infected you are not going to have a severe attack and secondly even those who got the disease were not infecting others,” he said.
The serum institute and Indian Council of Medical Research (ICMR), the apex body in the country for biomedical research, on Nov 11, announced the completion of enrollment of phase 3 clinical trials for Covishield.
ICMR and SII have also collaborated for clinical development Covovax (Novavax), developed by Novavax, US, and upscaled by the SII. EFE-EPA