COVID-19 Vaccine

COVAXIN

COVAXIN^TM, 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]

[Clinical Registry details Phase III]

Update

• Pre-clinical studies with small and large animals COMPLETED.

  Scientific Report: 1 2 3

• DCGI 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
  [Accepted in lancet infectious diseases and in press]
• 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.

Covishield

The Serum Institute of India (SII) and Indian Council of Medical Research are jointly conducting a Phase II/III, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine).

[Clinical Registry details]

[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.

ZyCoV-D

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]

Update

• DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
• Phase I Human Clinical Trial COMPLETED
• Phase II Human Clinical Trial ONGOING
• DCGI approval for Phase III Human Clinical Trials RECEIVED

Sputinik

Dr Reddys Laboratories Limited and Sputnik LLC are jointly conducting Multi-centre, phase II/III adaptive clinical trial to assess safety and immunogenicity of Gam-COVID-Vac combined vector vaccine.

[Clinical Registry details]

Update

• DCGI approval for Phase II & Phase III Human Clinical Trials RECEIVED
• Phase II Human Clinical Trial ONGOING.

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

[Clinical Registry details]

Update

• DCGI approval for Phase I & Phase II Human Clinical Trials RECEIVED
• Phase I/II Human Clinical Trial ONGOING