COVID-19 VACCINES UNDER TRIALS IN INDIA
1.0 COVAXIN
COVAXINTM, India's indigenous COVID-19 vaccine Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility.
The vaccine received approval from Drug Controller General of India (DCGI) for Phase I & II Human Clinical Trials and an Adaptive, Seamless Phase I, Followed by Phase II Randomized, Double blind, Multicentre Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152).
[Clinical Registry details Phase III]
Update 
Pre-clinical studies with small and large animals COMPLETED.
Scientific Report:
1. Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model
2. Remarkable immunogenicity and protective ecacy of BBV152, an inactivated SARS-CoV-2 vaccine in rhesus macaques
3. Evaluation of Safety and Immunogenicity of an Adjuvanted, TH-1 Skewed, Whole Virion InactivatedSARS-CoV-2 Vaccine - BBV152DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED.
Phase I Human Clinical Trial COMPLETED.
Phase 1: Safety and Immunogenicity Trial of an Inactivated SARS-CoV-2 Vaccine-BBV152
[Published at Lancet Infectious diseases: Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial ] : Link
Phase II Human Clinical Trial COMPLETED.
Phase 2: Safety and immunogenicity clinical trial of an inactivated SARS-CoV-2 vaccine, BBV152
DCGI approval for Phase III Human Clinical Trials RECEIVED.
Phase III Human Clinical Trial ONGOING.
DCGI approval for restricted use in emergency situation RECEIVED.
[Scientific Report on ChAdOx1 nCoV-19]
Update
Promising result of Pre-clinical animal studies SHOWN
Scientific Report: 1
DCGI approval for Phase II & Phase III Human Clinical Trials RECEIVED
Scientific Report: 1
Participants enrollment and vaccination of Phase II/III Human Clinical Trial COMPLETED.
DCGI approval for restricted use in emergency situation RECEIVED.
Zydus Cadila, focused on discovering and developing NCEs, Novel Biologicals, Biosimilars and Vaccines, announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D. Safety in Phase I clinical trial of ZyCoV-D in healthy subjects established as endorsed by the independent Data Safety Monitoring Board (DSMB). Zydus commenced Phase II trial.
[Clinical Registry details Phase III]
Update
- DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
- Phase I Human Clinical Trial COMPLETED
- Phase II Human Clinical Trial COMPLETED
- Phase III Human Clinical Trial ONGOING
- DCGI approval for Phase III Human Clinical Trials RECEIVED
Update
DCGI approval for Phase II & Phase III Human Clinical Trials RECEIVED
Phase II Human Clinical Trial ONGOING.
5.0 Biological E’s novel Covid-19 vaccine
Biological E. Limited is conducting a prospective open label randomised Phase-I seamlessly followed by Phase-II study to assess the safety, reactogenicity and immunogenicity of Biological E’s novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for protection against Covid-19 disease when administered intramuscularly in a two dose schedule(0, 28D) to healthy volunteers
Update
DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
Phase I/II Human Clinical Trial ONGOING
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