DCGI approves indigenous mRNA Covid jab for emergency use in 18 yrs & above

By Sumit Blogs -

India’s drug regulator on Tuesday approved India’s first home-grown mRNA Covid-19 vaccine by Gennova Biopharma for emergency use in 18 years and above.

The mRNA vaccine-Gemcovac-19 is developed by Pune-based Gennova Biopharmaceuticals.

“Gennova delivers on the promise of a thermostable mRNA vaccine. India’s first mRNA vaccine Gemcovac-19 gets EUA,” Sanjay Singh, CEO, Genova confirmed.

The Subject Expert Committee (SEC) under the drug regulator had recommended granting EUA to the vaccine in a meeting held on Friday.

The company has conducted Phase-2/3 trials on 4,000 participants to evaluate the vaccine’s safety, immunogenicity and tolerability.

The vaccine was found to be “safe, well tolerated and immunogenic,” people in the know told ET.

“The adverse events reported in the clinical trials were mild to moderate and mostly self resolved,” they added.

About 70 lakh doses of the vaccine have already been cleared by the government’s nodal Central Drug Laboratory (CDL) at Kasauli and it is expected to be available from next month.

The company will start its negotiation process on the price of the vaccine with the government and private market soon, the people said.

The decision to be put up in the government’s programme or not will be taken by the National Technical Advisory Group on Immunisation (NTAGI) later. However, the vaccine will be available in the private market.

The recommendation has been sent to the Drug Controller General of India which will soon decide on the approval, the same people 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 mRNA Covid vaccine to the drug regulator. After that, the Central Drug 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.

Gennova had said earlier that its vaccine would not require sub-zero temperature for storage, a feature that would make its rollout in India easy. The mRNA jabs of Pfizer 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.

Credits – Source – https://ift.tt/TUIfsW4

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