NEW DELHI (Reuters) – Ocugen Inc plans to sell 100 million doses of state-backed COVID-19 vaccine in the United States this year, U.S. company chief executive Shankar Musunuri told Reuters on Monday.
Musunuri said Ocugen, a Pennsylvania-based biopharmaceutical company, was aiming to launch the vaccine developed in India in the second quarter of 2021, initially with photos taken before they started doing there.
The United States has already approved COVID-19 vaccines developed by Pfizer / BioNTech, Moderna and Johnson & Johnson for emergency use.
Two-dose COVAXIN of India has been found to be 81% effective in an interim study of late test data on some 26,000 people in India, said developer Bharat Biotech and Research Council The state’s Indian medicine this month.
Bharat Biotech says up to 40 countries are interested in COVAXIN and has already applied for emergency licenses in Brazil and the Philippines. Crashing the U.S. market would be an important milestone for the company and the Indian vaccine industry, the largest in the world.
Musunuri said Ocugen had held initial talks with the U.S. Food and Drug Administration and planned to seek emergency use permission in April.
“They are very pleased with the way the interim analysis is being conducted,” Musunuri said, adding that Ocugen had a “regulatory path” to take the process forward.
Musunuri said COVAXIN had the ability to work against COVID-19 modifications and that Ocugen could focus on children first because it seemed to be safe for those older than 12, while photos were taken. other drug dealers targeted adults.
Pfizer vaccine has been approved for emergency use in the United States for individuals 16 years and older, with the other two being licensed for emergency use in people 18 years of age or older.
“Like polio virus given to babies, this could be safe for 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, after a study conducted by the Indian company in January showed that the bullet was likely to be effective against the British strain of the coronavirus.
India’s drug regulator COVAXIN approved its emergency use in January for people over 12, saying it could work against the virus as a whole instead of just the “spike-protein” tip. has it, which can make it more effective for fear of mutations.
Musunuri said this could mean it could be used as a booster for people who have already been vaccinated with the first dose of other pictures.
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 U.S. rights to the vaccine and will be responsible for its clinical development, regulatory approval and commercialization there. Bharat Biotech also leverages its technology, retaining 55% of the profits.
Shares in Ocugen have nearly tripled this year, bringing it to market capitalization of $ 2 billion, aided by a spike when Bharat Biotech announced the test results at a late stage.
More than 2 million priority adults have been given COVAXIN in India since the country’s vaccination campaign began in mid-January. Bharat Biotech says it wants to make about 700 million doses a year at home.
Reciting with Krishna N. Das; Edited by Alexander Smith