'Approved, safe, effective': SII CEO Adar Poonawalla says Covishield is ready to roll out

By PTI
PUNE: Serum Institute of India CEO Adar Poonawalla on Sunday said the Oxford-AstraZeneca COVID-19 vaccine ‘Covishield’ is ready to roll out in the coming weeks.

Poonawalla’s remarks came soon after after India’s drugs regulator approved Covishield for restricted emergency use.

“Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off.”

Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks. pic.twitter.com/TcKh4bZIKK
— Adar Poonawalla (@adarpoonawalla) January 3, 2021

“COVISHIELD, India’s first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks,” Poonawalla tweeted.

“Thank you Hon. Sri @narendramodi Ji, Hon. Sri @drharshvardhan Ji, @MoHFW_INDIA @ICMRDELHI @DBTIndia #DCGI_India @UniofOxford @AstraZeneca @gavi @GaviSeth @gatesfoundation and @BillGates for your support,” he added.

COVID-19 vaccines of Serum Institue of India and Bharat Biotech have been granted permission for restricted use in emergency situation, said Drugs Controller General of India (DCGI) on Sunday. 

#BREAKING | A very happy new year indeed! India’s drug controller has approved #Covaxin and #Covishield for emergency use in the country.#Covid19vaccine #CovidVaccine pic.twitter.com/QQWMzWufxs
— The New Indian Express (@NewIndianXpress) January 3, 2021

The SEC of Standard Drug Organisation met on 1st and 2nd Jan and made recommendations in respect of proposal of restructed emergency approval of COVID-19 vaccine of SII, according to DCGI.

SII Pune has submitted safety immunogenisity and efficacy data generated on 23,745 participants aged more than or equal to 18 years or older from overseas clinical studies, said VG Somani, DCGI.