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 the Drugs Controller General of India (DCGI) approved Serum Institute's 'Covishield' vaccine along with Bharat Biotech's 'Covaxin' for restricted emergency use in India.
"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," 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.
"After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial," said VG Somani, DCGI, during a media briefing today.
"We'll never approve anything if there is slightest of safety concern. The vaccines are 100% safe. Some side effects like mild fever, pain and allergy are common for every vaccine. It (people may get impotent) is absolute rubbish," he added.
The SEC of Standard Drug Organisation met on Jan 1-2 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, he added.
The overall vaccine efficacy was found to be 70.42%. Further, SII was granted permission to conduct phase II/phase III clinical trial on 1,600 participants within the country, according to DCGI.
"The firm also submitted the interim safety and immunogenisity data generated from this trial and the data was found comparable from the data from overseas clinical studies," said Somani.
"After detailed deliberations SEC has recommended for grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing the country by the firm will continue," he added.
Serum and Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C, said DCGI.
