The SEC recommended the authorisation in a meeting held on Friday. The vaccine is developed by Pune-based Gennova Biopharmaceuticals.
The recommendation has been sent to the Drugs Controller General of India which will soon decide on the approval, the same people said.
In its meeting on Friday, the SEC reviewed data on Gennova’s mRNA vaccine.
Trials Done on 4,000 Participants
“The experts were satisfied with the data and recommended EUA for the vaccine,” a senior government official said.
Earlier this month, Gennova had approached the drug regulatory authority seeking EUA for the vaccine.
Gennova had in April submitted interim data on the indigenously developed vaccine to the drug regulator. After that, the Central Drugs Standard Control Organisation had sent some queries to the company.
“The company had later come back to the drug regulator and submitted additional data,” the official said.
- In April, Gennova submitted interim data on vaccine CDSCO had sent some queries to co on data
- Co had later come back to drug regulator and submitted additional data
The company has conducted Phase-2/3 trials on 4,000 participants to evaluate the vaccine’s safety, immunogenicity and tolerability.
Gennova had earlier said its vaccine would not require sub-zero temperature for storage, a feature that would make its roll-out in India easy. The mRNA jabs of
and Moderna need sub-zero temperature.
While India’s eligible population has received the primary dose of the Covid-19 vaccines, NITI Aayog member VK Paul had said the mRNA platform continued to be “important in the medium term, near future and beyond”.
“We need the mRNA platform because it is a new platform, it has shown to be effective worldwide,” Paul had said.
According to him, the mRNA platform would be useful for developing vaccines for other diseases like malaria, dengue and TB as well. Gennova is also developing an Omicron-specific vaccine on its mRNA platform, with the Omicron variant of Covid-19 becoming the dominant strain.
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