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DCGI approves indigenous mRNA Covid jab for emergency use in 18 yrs & above; Covovax for 7-11 yrs

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.

Gennova Biopharmaceuticals, mRNA vaccine, DCGI, covid, covid 19, covid vaccine, health news, covid news,
Gennova Biopharmaceuticals Ltd. is planning to produce around 40-50 lakhs of doses per month and this capacity can be quickly doubled.GEMCOVAC™-19 has reached the primary endpoint of Phase III clinical trial. The clinical data were evaluated by the Central Drugs Standard Control Organisation (CDSCO). The vaccine was found to be safe, well-tolerated and immunogenic, the company claims. Gennova Biopharmaceuticals Ltd. is planning to produce around 40-50 lakhs of doses per month and this capacity can be quickly doubled. "Beyond India, Gennova aims at providing sustainable access to low-and middle-income countries around the world to the vaccine to blunt the spread of the pandemic," it stated. Last week, the Subject Expert Committee (SEC) in a meeting held on Friday recommended Emergency Use Authorisation (EUA) for the mRNA vaccine against COVID-19.

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.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. 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 last year. 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 for adolescents in the age group of 15-18 years. 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.

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