New Delhi: The Drugs Controller General of India (DCGI) on Tuesday, June 28 approved India's first indigenously developed mRNA vaccine against COVID-19. The vaccine is manufactured by Gennova Biopharmaceuticals, based in Pune, and designed 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 Central Drugs Standard Control Organisation (CSDCO) 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.

Also read: 'Over 42 lakh Deaths in India Prevented by COVID Vaccines in 2021': Lancet Study

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 committee, in its last meeting in April, had sought more data from the Pune-based firm over the application.

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, 2022. 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, 2021.

The next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.

India launched vaccination for all people aged more than 45 years from April 1, 2021. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last year.

The next phase of vaccination commenced from January 3, 2022 for adolescents in the age group of 15-18 years.

Also read: NTAGI Recommends Reducing COVID Booster Dose Gap to Six Months

India began administering precaution doses, also called booster dose, 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.

(PTI)

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