The Subject Expert Committee under India's drug regulator has found data submitted by Gennova Biopharmaceuticals "satisfactory".
The Drugs Controller General of India (DCGI) has approved two doses of Pune-based Gennova Biopharmaceuticals' mRNA COVID-19 vaccine for restricted use in emergency situations for beneficiaries aged above 18 years age group. It is for the first time ever that this vaccine remains stable during storage even at 2-8 degrees Celsius, sources said on Tuesday.
The Subject Expert Committee (SEC) has recommended Emergency Use Authorisation (EUA) for India's first mRNA vaccine on Friday meeting, sources said to ANI. The Subject Expert Committee under India's drug regulator has found data submitted by Gennova Biopharmaceuticals "satisfactory". The company submitted data in the month of April. Then, they submitted more additional data in the month of May.
Earlier in the month of May, Gennova released the statement to ANI regarding updates on submitting phase 3 data which read, "Gennova is in communication with the regulatory agency and submitting all necessary data and information required for the product approval." They also said, "Product development, using innovative technologies like mRNA, a fourth-generation vaccine platform is stable at 2-8 degrees Celsius, is a challenging journey during pandemic times."
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The company has conducted phase 2 and phase 3 data trials on 4000 participants to evaluate vaccine safety, immugenicity and tolerability. The Union Government is committed to accelerating the pace and expanding the scope of COVID-19 vaccination throughout the country. The nationwide COVID-19 vaccination started on January 16, 2021.
The new phase of universalization of COVID-19 vaccination commenced on June 21, 2021. The vaccination drive has been ramped up through the availability of more vaccines, advance visibility of vaccine availability to States and UTs for enabling better planning by them and streamlining the vaccine supply chain.
As part of the nationwide vaccination drive, the Government of India has been supporting the States and UTs by providing them with COVID-19 vaccines free of cost. In the new phase of the universalization of the COVID-19 vaccination drive, the Union Government will procure and supply (free of cost) 75 per cent of the vaccines being produced by the vaccine manufacturers in the country to States and UTs.
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