Bharat Biotech COVAXIN® (BBV152)

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 20211)

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

Factsheet

Preclinical Trials

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

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

Posted December 29, 2021: Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (BBV152) in children from 2 to 18 years of age: an open-label, age-de-escalation phase 2/3 study

Authorizations

On January 3, 2021: India's Ministry of Health & Family Welfare announce a statement from DCGI - Central Standards Control Organization (CDSCO) Granting permission for emergency use of Covaxin.2)3)4)5)

On November 5, 2021, Ocugen submitted Emergency Use Authorization Request to the US FDA for Investigational COVID-19 Vaccine COVAXIN™ (BBV152) for Children Ages 2-18 Years

On November 26, 2021 the US FDA put the application on hold for Covaxin and will advise what additional deficiencies are required to be corrected/fulfilled.

Other Studies

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