In order to respond quickly and effectively to the COVID-19 pandemic, a broad range of candidate COVID-19 vaccines are being investigated globally using various technologies and platforms. These include viral-vectored, protein subunit, nucleic acid (DNA, RNA), live attenuated and inactivated vaccines. Some of these candidates have entered clinical trials.
Title: 37th WHO Regulatory Update on COVID-19
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]
[Clinical Registry details Paediatric Study]
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Scientific Report:
1. Immunogenicity and protective efficacy of BBV152, whole virion inactivated SARS- CoV-2 vaccine candidates in the Syrian hamster model; iScience 24, 102054, February 19, 2021
2. Immunogenicity and protective efficacy of inactivated SARS-CoV-2 vaccine candidate, BBV152 in rhesus macaques, Published at Nature Communication; NATURE COMMUNICATIONS | (2021) 12:1386
3. Th1 Skewed immune response of Whole Virion Inactivated SARS CoV 2 Vaccine and its safety evaluation; iScience 24, 102298, April 23, 2021
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).
[Scientific Report on ChAdOx1 nCoV-19]
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Scientific Report: 1
Scientific Report: 1
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 Phase III]
[Clinical Registry details Phase I/II]
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Sputnik V
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.
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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 Phase I/II]
[Clinical Registry details Phase II/III]
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BBV154 - Intranasal vaccine
Bharat Biotech is conducting Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. BBV154 is an intranasal vaccine stimulates a broad immune response – neutralizing IgG, mucosal IgA, and T cell responses. Immune responses at the site of infection (in the nasal mucosa) – essential for blocking both infection and transmission of COVID-19
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COVOVAX
Indian Council of Medical Research and Serum Institute of India jointly performing a phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults
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mRNA based vaccine (HGCO19)
Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects. The trial is being conducted by Gennova Biopharmaceuticals Limited.
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CORBEVAX
Corbevax is a protein subunit COVID-19 vaccine developed by Texas Children's Hospital Center for Vaccine Development and Baylor College of Medicine in Houston, Texas and Dynavax technologies based in Emeryville, California. It is licensed to Indian biopharmaceutical firm Biological E. Limited (BioE) for development and production.
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