Covid-19: Indian drug regulator approves indigenous mRNA vaccine for emergency use

The Drugs Controller General of India (DCGI) on Tuesday 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, official sources said on Tuesday.

While other mRNA vaccines require to be stored at sub-zero temperatures, Gennova’s mRNA vaccine can be stored at 2-8 degrees, an official source told PTI.

The drug regulator has also approved Serum Institute’s Covid-19 vaccine Covovax for restricted emergency use in children aged 7 to 11 years subject to certain conditions.

The DCGI’s nod came after the subject expert committee on Covid-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years and Gennova’s two dose m-RNA vaccine for 18 years and above, official sources said.

Prakash Kumar Singh, director, Government and Regulatory Affairs at Serum Institute of India (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.

The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12 to 17 years age group subject to certain conditions on March 9.

Gennova developed the mRNA vaccine with the support of the Department of Biotechnology (DBT) under the Ministry of Science and Technology and its PSU, Biotechnology Industry Research Assistance Council (BIRAC).

The country began inoculating children aged 12-14 years from March 16. The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year.

India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10. Precaution dose of Covid-19 vaccines for all aged above 18 years began at private vaccination centres from April 10.