New Delhi: The first MRNA Messenger vaccine in the country is expected to start a trial in humans in February.
Pune-based Biopharmaceuticals Gennova has submitted data phase 2 MRNA vaccine and has also completed the recruitment of data phase 3.
The drug controller General Committee of the India Subject Experts (DCGI) (SEC) is expected to review data immediately, the official source said.
Gennova Biopharmaceutical has also developed the MRNA vaccine for Omicron variants to be tested in humans for efficacy and imunogenicity immediately, the official source said.
Previously in September 2021, Gennova issued a press statement and updated on vaccine tests, “Indian drug controllers, have agreed to the Phase II and Phase III study protocol for HGCO19, Vaksin Covid-19 based on India’s first MRNA, developed by Gennova Biopharmaceuticals Limited (” Gennova “) back in August.” “Gennova has submitted interim clinical data from the phase that I learned to the Standard Control Organization Center (CDSCO), the Government of the Indian National Regulatory Authority (NRA).
The vaccine subject expert committee (sec) has reviewed data Phase I Interim, and found that HGCO19 was safe, can be tolerated, and immunogenic in research participants, “he said the company also mentioned the number of trial sites,” this research is being carried out in India around 10-15 sites in phase II and 22-27 sites in the site Phase III.
Gennova uses the DBT-ICMR clinical test network site for this study.
“The MRNA vaccine is included in the category of nucleic acid vaccine, Which uses genetic material from viruses causing diseases or pathogens to trigger the immune response to it in the body.