Bharat Biotech’s COVAXIN Phase III data published in The Lancet

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Bharat Biotech’s COVAXIN Phase III data published in The Lancet
Bharat Biotech,announced on Thursday that the safety and efficacy analysis data from Phase III clinical trials of COVAXIN is peer-reviewed and published in The Lancet.

The Lancet peer-review confirms the efficacy analysis which demonstrates COVAXIN®️ to be effective against COVID-19. COVAXIN®️is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2%.

● Efficacy analysis demonstrates COVAXIN®️ to be 77.8% effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group
● Efficacy analysis demonstrates COVAXIN®️ to be 93.4% effective against severe symptomatic COVID-19
● Safety analysis demonstrates adverse events reported were similar to placebo, with 12% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events
● Efficacy data demonstrates 63.6% protection against asymptomatic COVID-19
● Efficacy data demonstrates 65.2% protection against the SARS-CoV-2, B.1.617.2 Delta
● Efficacy data demonstrates 70.8% protection against all variants of SARS-CoV-2 virus

COVAXIN®️ was developed under a partnership with the Indian Council of Medical Research and the National Institute of Virology, with Bharat Biotech receiving the SARS-COV-2 strains through this collaboration.
Bharat Biotech had established an ongoing collaboration with ViroVax since 2019, through the Indo-U.S. Vaccine Action Program, to develop and evaluate IMDG (Alhydroxiquim-II), a novel TLR7/8 agonist molecule, which is formulated as part of the adjuvant in COVAXIN®️. The Adjuvant Program of the U.S. National Institute of Allergy and Infectious Diseases (NIAID) has supported ViroVax since 2009.

Recently, the World Health Organization granted emergency use listing to COVAXIN®️ enabling countries to expedite their regulatory approval to import and administer doses. It has also received emergency use authorizations in several countries with applications in process in more than 50 countries worldwide. Bharat Biotech has partnered with Ocugen to obtain approvals for COVAXIN®️ in the United States and Canada.