Exclusive: Ocugen plans to sell 100 million Indian vaccine doses in U.S. in 2021

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Indian Health Minister Harsh Vardhan holds a dose of Bharat Biotech’s COVID-19 vaccine called COVAXIN, during a vaccination campaign at All India Institute of Medical Sciences (AIIMS) hospital in New Delhi, India, January 16, 2021. REUTERS/Adnan Abidi/File Photo

NEW DELHI (Reuters) – Ocugen Inc plans to sell 100 million doses of India’s state-backed COVID-19 vaccine in the United States this year, the U.S. firm’s chief executive Shankar Musunuri told Reuters on Monday.

Musunuri said Ocugen, a Pennsylvania-based biopharmaceutical firm, was aiming to launch the Indian-developed vaccine in the United States in the second quarter of 2021, initially with imported shots before beginning production there.

The United States has already authorized COVID-19 vaccines developed by Pfizer/BioNTech, Moderna and Johnson & Johnson for emergency use.

India’s two-dose COVAXIN has been found to be 81% effective in an interim analysis of late-stage trial data on some 26,000 people in India, its developers Bharat Biotech and the state-run Indian Council of Medical Research said this month.

Bharat Biotech says as many as 40 countries are interested in COVAXIN and it has already sought emergency approvals in Brazil and the Philippines. Cracking the U.S. market would be a significant milestone for the company and India’s vaccine industry, which is the world’s largest.

Musunuri said Ocugen had held initial talks with the U.S. Food and Drug Administration and planned to seek emergency use authorization in April.

“They’re fine with the way the interim analysis is being done,” Musunuri said, adding that Ocugen had “a regulatory path” to take the process forward.

Musunuri said COVAXIN had the potential to work against COVID-19 variants and Ocugen could initially focus on children as it was likely to be safe for those over the age of 12, while shots produced by other drugmakers targeted adults.

Pfizer’s vaccine has been authorized for emergency use in the United States for individuals 16 years and older, with the other two given authorization for emergency use in people 18 years and above.

“Like a polio virus given to babies, this could be safe for all children, high-risk groups, pregnant women and people with comorbidities,” Musunuri said of COVAXIN.

BOOSTER SHOT

He said Ocugen was expecting more data from Bharat Biotech on COVAXIN, following up on a study by the Indian company in January which showed the shot was likely to be effective against the British strain of the coronavirus.

India’s drug regulator approved COVAXIN for emergency use in January for people above 12, saying it could act against the whole body of a virus instead of just its “spike-protein” tip, potentially making it more effective in case of mutations.

Musunuri said this could mean it could be used as a booster for people already vaccinated with a first dose of other shots.

He said Bharat Biotech would export “tens of millions of doses” to Ocugen, which is also finalizing U.S. contract- manufacturers for the product.

Ocugen will have the U.S. rights to the vaccine and will be responsible for its clinical development, regulatory approval and commercialization there. Bharat Biotech will also transfer its technology, and keep 55% of the profit.

Shares in Ocugen have nearly tripled this year, taking it close to a $2 billion market capitalization, helped by a spike when Bharat Biotech announced its late-stage trial results.

COVAXIN has been given to more than 2 million prioritized adults in India since the country’s vaccination drive began in mid-January. Bharat Biotech says it wants to produce about 700 million doses a year domestically.

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