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: 34th 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
Update
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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