GEMCOVAC™-19 mRNA Vaccine Description
GEMCOVAC™-19 is an mRNA vaccine developed in India that received Emergency Use Authorization for adults from the office of the Drugs Controller General of India on June 29, 2022.
This mRNA technology provides flexibility to quickly tweak the vaccine for any existing or emerging coronavirus variants, and this technology platform will empower India to be pandemic ready, says the developer Gennova. mRNA vaccines are highly efficacious because of their inherent capacity of being translated into the protein structure inside the cell cytoplasm. mRNA vaccines are considered safe as mRNA is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms.
Gennova Biopharmaceuticals Ltd., a subsidiary of Emcure Pharmaceuticals Ltd., is headquartered in Pune, India, a biotechnology company dedicated to developing, producing, and commercializing biotherapeutics to address life-threatening diseases across various indications.
Local media reported India's National Technical Advisory Group on Immunisation is scheduled to meet on July 20, 2022, to determine GEMCOVAC-19's distribution.
GEMOVAC-19 is a two-dose vaccine administered intramuscularly 28 days apart.
GEMCOVAC-19 Side Effects
GEMCOVAC-19 was found to be safe, well-tolerated, and immunogenic in Phase 3 clinical trial.
June 29, 2022 - Local media reported the company claimed that it aims to produce around 40 – 50 lakhs of doses per month, and this capacity can be quickly doubled.
May 14, 2022 - Local media reported a Gennova Biopharmaceuticals spokesperson told ANI that the company hasn't violated the protocol related to the clinical trial and will be submitting all necessary data for product approval.
GEMCOVAC-19 Clinical Trials
A Prospective, Multicentre, Randomized, Phase II study seamlessly followed by a Phase III study to Evaluate the Safety, Tolerability, and Immunogenicity of the candidate GEMCOVAC-19 (COVID-19 vaccine) in healthy pediatric subjects of 5 to less than 18 years.