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Ocugen (OCGN) Selects Coronavirus Vaccine Manufacturer in US

·3 min read

Ocugen, Inc. OCGN 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%.

Zacks Investment Research
Zacks Investment Research

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 BNT162b2, Moderna’s MRNA mRNA-1273 and J&J’s JNJ 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.

Zacks Rank

Ocugen currently has a Zacks Rank #4 (Sell). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Johnson & Johnson (JNJ) : Free Stock Analysis Report

Moderna, Inc. (MRNA) : Free Stock Analysis Report

Ocugen, Inc. (OCGN) : Free Stock Analysis Report

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