India's first home-grown mRNA Covid-19 vaccine by Gennova Biopharma has received the EUA approval from the Drugs Controller General of India (DCGI). The vaccine-GEMCOVAC-19, which is seen as a game-changer in the Indian healthcare industry, will be given to people aged 18 years and above.
The Indian mRNA vaccine has an edge over its other international competitors like Pfizer-BioNTech and Moderna's vaccines as it does not require sub-zero temperatures for its storage.
Media reports said that the Subject Expert Committee (SEC) has recommended granting the Emergency Use Authorisation (EUA) to the Gennova Bio's vaccine.
"Vaccine is based on second wave, phase 3 trials going on. We got good safety &efficacy results. We'll roll out vaccine, as NTAGI gives permission within 72 hours. We can produce 200-300 million doses," Sanjay Singh, CEO, Gennova Biopharmaceuticals Ltd.
Earlier, trials were conducted on 4000 volunteers and this was reviewed by the SEC. The Central Drugs Standards Control Organisation (CDSCO) had raised some queries after Gennova submitted interim data from the trials in April. The, the company submitted additional data to the CDSCO. After this, the company approached CDSCO for its approval.
Gennova had released a statement to news agency ANI last month regarding updates on submitting phase 3 data.
"Gennova is in communications with the regulatory agency and submitting all necessary data and information required for the product approval," Gennova's spokesperson said.
Gennova is an arm of Emcure Pharma Co that aims to produce around 40-50 lakh doses of the vaccine monthly which can be further doubled in a short amount of time. Beyond India, Gennova aims at providing the vaccine to low-and middle-income countries around the world
First Published: Jun 29, 2022 4:40 PM IST