An expert panel, Subject Expert Committee (SEC) on COVID-19 of India’s central drug authority recommended Emergency Use Authorization (EUA) for Serum Institute of India’s Covovax vaccine for children aged 7-11.
According to sources as quoted by IANS, the SEC of Drugs Controller General of India (DGCI) has recommended Serum Institute of India’s vaccine Covovax for children aged 7-11 years.
The expert panel recommendation has been sent to the DCGI for final approval. The two applications were submitted by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII) on March 16 and June 1.
However, DGCI will review the recommendation before noding for final approval. The expert panel in its last meeting in April had sought more information from Serum Institute over the application, as per the source.
India`s drug regulator had approved Covovax for restricted use in emergency situations in adults on December 28, 2021 and in the 12-17 age group with certain conditions on March 9.