DGCI will review the recommendation before nodding for final approval
Drugs Controller General of India (DCGI) on Friday recommended Emergency Use Authorization (EUA) for Serum Institute of India’s Covovax vaccine for children aged 7-11, a source on Friday.
Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). Covovax (Novavax) is the only vaccine manufactured in India that is also sold in Europe and has an efficacy of 90%, according to SII, Pune.
“The Subject Expert Committee of Drugs Controller General Of India has recommended Serum Institute of India’s (SII) vaccine Covovax for children in the age group of 7-11 years,” said the source.
The expert panel recommendation has been sent to the DCGI for final approval.
However, DGCI will review the recommendation before nodding 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.
India is witnessing a massive spike in daily COVID-19 cases with 15,940 new COVID-19 infections being reported in the last 24 hours. The ministry also informed that the active cases comprise 0.21 percent of the total infections, while the national COVID-19 recovery rate has been recorded at 98.58 percent.
[With Inputs from IANS]
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