SEC recommends EUA for Covishield, DCGI nod awaited
The SEC is also looking at the EUA applications of Pfizer and Bharat Biotech
CDSCO’s Subject Expert Committee (SEC) on COVID-19 has endorsed emergency use authorisation (EUA) for Oxford University-Astrazeneca’s COVID-19 vaccine candidate ‘Covishield’, as per reports. It is the first vaccine candidate to get a recommendation from the expert panel for EUA in India. The approval from Drug Controller General of India (DCGI) is awaited.
Serum Institute of India (SII) is partnering with AstraZeneca to manufacture Covishield.
The SEC had earlier sought additional safety and immunogenicity data from SII and met today to review the matter. SII had applied to the DCGI for EUA for Covishield on December 6, 2020.
The SEC is also looking at the EUA applications of Pfizer and Bharat Biotech. It has started reviewing the EUA application for Bharat Biotech’s Covaxin, but a final decision has not been taken yet, as per reports.
Earlier, VG Somani, Drug Controller General of India had hinted that India may grant EUA for a COVID-19 vaccine in the New Year.