
The Drugs Controller General of India (DCGI) has approved the restricted emergency use authorisation to the Pune-based Serum Institute of India's coronavirus (COVID-19) vaccine 'Covovax' for children aged between 7 to 12 years, India-based news agencies reported on Tuesday (June 28) citing sources.
Sources said that DCGI also approved India's first indigenously developed mRNA vaccine against COVID-19 manufactured by Gennova Biopharmaceuticals for restricted emergency use for those aged 18 years and above. As per the source, approval has been given with certain conditions.
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Gennova's mRNA vaccine can be stored at 2-8 degrees, an official source told news agency PTI. Notably, other mRNA vaccines require to be stored at sub-zero temperatures.
Previously, DCGI had approved Covovax for restricted use in adults on December 28. The approval was given to the age group 12 to 17 years, subject to certain conditions, on March 9.
Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII had submitted an application to DCGI in this regard on March 16, official sources had said.
The expert panel, in its last meeting in April, had sought more data from the Pune-based firm over the application.
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