VK Paul, member (health), NITI Aayog, and head of the national task force for COVID-19, also said on Tuesday that of the two companies which were asked for additional data to receive emergency use approval for their COVID vaccines for emergency use authorisation (EUA), one has submitted them to the CDSCO.
SII Seeks Emergency Approval
The SII along with Bharat Biotech had applied for the emergency authorisation of their COVID-19 vaccines with the DCGI earlier this month.
Covishield has been developed at SII’s laboratory in Pune with a master seed from Oxford University/Astra Zeneca.
However, their applications were not approved as the SEC found inadequate safety and efficacy data of the vaccines in a review meeting held on 9 December.
The SEC had recommended the firms to furnish further safety and efficacy data in order to receive the EUA for their COVID vaccines.
The SEC had asked SII to submit an updated safety data of Phase 2 and 3 clinical trials in the country, immunogenicity data…