Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller nod to initiate Human clinical trials

▴ Indigenous mRNA vaccine candidate supported by DBT gets Drug Controller nod to initiate Human clinical trials
Gennova gears up to launch mRNA vaccine for Covid

India’s first indigenous mRNA vaccine candidate has received approval from Indian Drug regulators to initiate Phase I/II human clinical trial. The novel mRNA vaccine candidate, HGCO19 has been developed by Gennova, Pune and supported with seed grant under the Ind-CEPI mission of Department of Biotechnology of M/o Science & Technology.

The mRNA vaccines do not use the conventional model to produce immune response. Instead, mRNA vaccine carries the molecular instructions to make the protein in the body through a synthetic RNA of the virus. The host body uses this to produce the viral protein that is recognized and thereby making the body mount an immune response against the disease. mRNA-based vaccines are scientifically the ideal choice to address a pandemic because of their rapid developmental timeline. The mRNA vaccine is considered safe as is non-infectious, non-integrating in nature, and degraded by standard cellular mechanisms. They are expected to be highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm. Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, e.g., eggs or bacteria. Therefore, they can be quickly manufactured in an inexpensive manner under cGMP conditions to ensure their "availability" and "accessibility" for mass vaccination on a sustainable basis.

Gennova, in collaboration with HDT Biotech Corporation, Seattle, USA, has worked together to develop an mRNA vaccine candidate. HGCO19 has already demonstrated safety, immunogenicity, neutralization antibody activity in animals. The neutralizing antibody response of the vaccine in mice and non-human primates was comparable with the sera from the convalescent patients of COVID-19.

Gennova’s vaccine candidate uses the most prominent mutant of spike protein (D614G) and also uses the self-amplifying mRNA platform, which gives the advantage of a low dosing regimen compared with the non-replicating mRNA or traditional vaccines. HGCO19 uses the adsorption chemistry so that the mRNA is attached on the surface of the nano-lipid carrier to enhance the release kinetics of the mRNA within the cells compared to the encapsulation chemistry.

HGCO19 is stable at 2-8°C for two months. Gennova has completed all preliminary work and should be initiating the Phase I/II Human clinical trial soon since the approval from the DCGI office has been received.

The Department of Biotechnology, Ministry of Science & Technology, Government of India is implementing the IndCEPImission ‘India Centric Epidemic Preparedness through Rapid Vaccine Development: Supporting Indian Vaccine Development’ which is aligned with the Global Initiative of CEPIand aims to strengthen the development of vaccines and associated competencies/technologies for the diseases of epidemic potential in India. The Ind-CEPI mission of DBT is implemented by its PSU, Biotechnology Industry Research Assistance Council ( BIRAC).

‘Establishment of a suchindigenous technology platform will not only empower India to handle the COVID-19 pandemic but also ensure the preparedness for future outbreaks’ said Dr Renu GennovaSwarup, Secretary, Department of Biotechnology and Chairperson BIRAC.

Tags : #mRNAVaccine #Gennova #BIRAC #DeapartmentofBiotechnology #HGCO19 #HDTBiotechCorporation

About the Author


Team Medicircle

Related Stories

Loading Please wait...

-Advertisements-




Trending Now

Eyes on the Future: Dr. Agarwal's Group Channels Rs 100 Crore for Cutting-edge Eye Hospitals Across KeralaDecember 06, 2023
Organ Transplant Scandal: Apollo Hospital Faces Government InquiryDecember 06, 2023
Breaking Barriers in Cancer Treatment: Max Healthcare's CAR-T Therapy PartnershipDecember 06, 2023
Exploring the Link Between Covid-19 Vaccination and Sudden Cardiac Arrests: ICMR StudyNovember 22, 2023
Powering the Future: China's Biodegradable Wireless System for Bioelectronic InnovationNovember 22, 2023
IMS BHU Pioneers Advanced Cardiac Care: Unveiling Cutting-Edge Technologies for Precise DiagnosisNovember 18, 2023
Inito's $6 Million Boost: Transforming Women's Health with AI-Backed Fertility MonitoringNovember 18, 2023
Madras High Court Advocates for Equality: PG Medical Students to Receive Incentive Marks for COVID-19 DutyNovember 18, 2023
Next-Gen Healthcare: CarePods and AI Redefine the Patient ExperienceNovember 17, 2023
Air Quality Crisis: Alarming Rise in Premature Births Linked to Air Quality in Begusarai, BiharNovember 17, 2023
Limerick Contest-2023: A Celebration of Wit and PoetryNovember 17, 2023
IIIT-Hyderabad among top 100 institutions for 5G Use Case LabNovember 17, 2023
Powerful, motivating and inspiring talks marked TEDx Hyderabad Women 2023 which was held with the theme "Two Steps ForwardNovember 17, 2023
Speaking the Diagnosis: How AI in Voice Analysis Is Revolutionizing Diabetes DetectionNovember 17, 2023
FDA Approves Zepbound: A New Medication for Weight Loss by Eli LillyNovember 17, 2023
CoverSelf Raises $8.2 Million in Seed Funding to Revolutionize Healthcare Claims with Innovative Fintech PlatformNovember 16, 2023
From Miracle to Medic: The Extraordinary Journey of India's First Paediatric Liver Transplant RecipientNovember 16, 2023
Combatting Chikungunya: Valneva's Chikungunya Vaccine Cleared by USFDA, Eyes India LaunchNovember 16, 2023
Global Corporate Summit 2023 with the theme Unlocking Opportunities in a Dynamic World heldNovember 16, 2023
2nd IHub-Data Mobility Summit heldNovember 16, 2023