India's first homegrown mRNA Covid-19 vaccine developed at Pune's Gennova Biopharmaceuticals on Tuesday received the Drugs Controller General of India (DCGI)'s nod for emergency use in 18 years and above, Indian Express reported.
While other mRNA vaccines require to be stored at sub-zero temperatures, Gennova's mRNA vaccine can be stored at 2-8 degrees.
This comes as the Subject Expert Committee (SEC) in a meeting held on Friday had recommended Emergency Use Authorisation (EUA) for the mRNA vaccine against Covid-19.
The SEC under India's drug regulator found data submitted by Gennova Biopharmaceuticals satisfactory in Friday's meeting.
The company had submitted the data back in April and provided additional data in May.
At the Pune-based firm, officials say they are excited and eager for a roll out.
Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals expressed confidence that the product will speak on its own merit for acceptability, given the proven track record of safety and efficacy of mRNA vaccines.
Gennova already has a license from the Central Drug Standard Control Organisation (CDSCO) to manufacture and sell the vaccine and has produced 70 lakh doses at risk.
Dr Singh said that with the EUA, the firm can ship the material soon after completing all formalities. "Our current production capacity is around 40-50 lakh of doses per month, which will be upgraded by two to three fold soon," Dr Singh added.
The fact that the novel mRNA vaccine candidate, GEMCOVAC™-19, is stable at 2-8 degrees makes it amenable for ease of deployment across the nation.
The two-dose vaccine will have to be administered intramuscularly, 28 days apart.
"Gennova intended to make an mRNA-vaccine formulation that is stable at 2- 8 °C and can be distributed through the already existing refrigeration supply chain pan-India. Given that early mRNA vaccine developers couldn't materialise such a product, freeze-drying the large and unstable mRNA molecule with the nanoparticle was a daunting challenge," an official at the firm said.
While more than 197 crore vaccine doses have been given to citizens 91 crore of whom are fully vaccinated, officials at Gennova said that there still was a potential demand for vaccine for one-third of the population. "There is a need of additional dose vaccination to control the infectivity of the ongoing pandemic and we are very positive that this vaccine will add another tool to the Indian vaccination programme," Dr Singh added.