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Vaccine type: Whole Virion Inactivated SARS-CoV-2 vaccine using a Vero Cell manufacturing platform
Commercial name: COVAXIN® (BBV152)
EUL holder: Bharat Biotech International Limited
Country: India
URL: https://www.bharatbiotech.com/
WHO Approved for Emergency Use Listing: 03 November 2021
Route of administration: Intramuscular
Shelf-life: 9 months at storage temperature: 2 to 8°C
Age indication: Adults from 18 years of age
Preservative: phenoxy ethanol with concentration: 2.5 mg/dose
Preclinical Product Development September 12, 2020 link
Animal Challenge Studies – Hamsters 16 Sep, 2020 link
Animal Challenge Studies – Rhesus Macaques - Published: 02 March 2021 link
Human Clinical Trials – Phase I - Published: January 21, 2021 link
Human Clinical Trials – Phase II - Published: March 08, 2021 link
Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B 1.1.7 variant of SARS-CoV-2 link
COVAXIN effectively neutralizes B.1.617 variant of SARS-CoV-2 link
Neutralization of B.1.1.28 P2 variant with sera of natural SARS-CoV-2 infection and recipients of BBV152 vaccine - April 30, 2021 link
The phase 3 clinical trial results were published in the Lancet on November 11, 2021.
Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial
On December 2, 2021 the US FDA put the BLA application on hold for Covaxin and will advise what additional deficiencies are required.