Ocugen, Inc. ( OCGN Quick Quote OCGN - Free Report) announced that it has selected Washington-based contract manufacturer, Jubilant HollisterStier as its manufacturing partner for its COVID-19 vaccine candidate, Covaxin, in the United States and Canada. Presently, the vaccine is not authorized/approved in either country.
Shares of Ocugen have skyrocketed 255.7% so far this year against the
industry’s decrease of 1.5%. Image Source: Zacks Investment Research Please note that Ocugen is looking to submit a biologics license application (“BLA”) for Covaxin in the United States. Last week, the company announced that it will no longer pursue an Emergency Use Authorization (“EUA”) for the vaccine, and instead, will seek more formal approval of the same.
Meanwhile, Ocugen has secured exclusive rights to commercialize Covaxin in Canada and has also initiated discussions with Health Canada for regulatory approval of the same.
We remind investors, that Ocugen has a definitive agreement with India-based Bharat Biotech to co-develop and commercialize the latter’s COVID-19 vaccine, Covaxin, for the United States market.
More than 30 million doses of the vaccine have been administered in India and other countries without any serious side effect being reported so far. The vaccine is currently being administered under EUA in 13 countries, with EUA applications pending in several others.
Notably, in April 2021, Bharat Biotech announced encouraging data from the second interim analysis of its phase III study of Covaxin, which showed 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization), and 70% efficacy against asymptomatic COVID-19 infection.
The vaccine is generally well tolerated and has an encouraging safety record so far.
If approved, Ocugen’s Covaxin will be the fourth vaccine to be available in the United States. At present
Pfizer/ BioNTech’s ( BNTX Quick Quote BNTX - Free Report) BNT162b2, Moderna’s ( MRNA Quick Quote MRNA - Free Report) mRNA-1273 and J&J’s ( JNJ Quick Quote JNJ - Free Report) single-shot COVID-19 vaccine are available in the United States.
Notably, Pfizer/BioNTech and Moderna have already initiated rolling submissions for a BLA with the FDA, seeking approval/licensure of their respective COVID-19 vaccines in the United States.
Ocugen currently has a Zacks Rank #4 (Sell). You can see
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