===== 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 2021((https://extranet.who.int/pqweb/vaccines/who-recommendation-bharat-biotech-international-ltd-covid-19-vaccine-whole-virion))	 	 
 	
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

[[https://www.bharatbiotech.com/images/covaxin/covaxin-factsheet.pdf|Factsheet]]
====Preclinical Trials ====
Preclinical Product Development September 12, 2020
[[https://www.biorxiv.org/content/10.1101/2020.09.09.285445v2|link]]

Animal Challenge Studies – Hamsters 16 Sep, 2020
[[https://www.researchsquare.com/article/rs-76768/v1|link]]

Animal Challenge Studies – Rhesus Macaques - Published: 02 March 2021
[[https://www.nature.com/articles/s41467-021-21639-w|link]]


==== Human Clinical Trials ====
Human Clinical Trials – Phase I - Published: January 21, 2021
[[https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30942-7/fulltext|link]]

Human Clinical Trials – Phase II - Published: March 08, 2021
[[https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00070-0/fulltext|link]]

Inactivated COVID-19 vaccine BBV152/COVAXIN effectively neutralizes recently emerged B 1.1.7 variant of SARS-CoV-2
 [[https://ocugen.com/wp-content/uploads/2021/05/Inactivated-COVID-19-vaccine-BBV152COVAXIN-effectively-neutralizes-recently.pdf|link]]

COVAXIN effectively neutralizes B.1.617 variant of SARS-CoV-2
[[https://ocugen.com/wp-content/uploads/2021/04/BioRxIv-Neutralization-of-variant-under-investigaton-B.1.617-with-sera-of-BBV152-vaccinees.pdf|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
[[https://www.biorxiv.org/content/10.1101/2021.04.30.441559v1|link]]

The phase 3 clinical trial results were published in the Lancet on November 11, 2021.\\
[[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02000-6/fulltext#tables|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: [[https://www.medrxiv.org/content/10.1101/2021.12.28.21268468v1|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.((https://www.bharatbiotech.com/images/press/bharat-biotech-covaxin-emergency-use-authorization-approval-by-dcgi-cdsco-moh-and-fw.pdf))((https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODA3Mw==))((https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/en/biotechver.pdf))((https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/cCOVAXIN-SMPC_BBIc.pdf))

On November 5, 2021, Ocugen [[https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-submission-emergency-use-authorization|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 [[https://ocugen.gcs-web.com/news-releases/news-release-details/ocugen-inc-provides-update-its-investigational-new-drug|hold]] for Covaxin and will advise what additional deficiencies are required to be corrected/fulfilled.


====Other Studies ====
Posted November 15, 2021: [[https://www.medrxiv.org/content/10.1101/2021.11.14.21266294v1.full-text|Inactivated virus vaccine BBV152/Covaxin elicits robust cellular immune memory to SARS-CoV-2 and variants of concern]]

Posted January 28, 2022: [[https://www.medrxiv.org/content/10.1101/2022.01.24.22269189v1|Covaxin (BBV152) Vaccine Neutralizes SARS-CoV-2 Delta and Omicron variants]]


====News ====