Ocugen Plans to Sell 100 Million Doses of Bharat Biotech’s Covaxin in US in 2021: Report
Ocugen Inc plans to sell 100 million doses of COVAXIN, developed by Bharat Biotech and backed by state-run ICMR, in the United States this year, the US firm’s chief executive Shankar Musunuri said on Monday.
Musunuri said Ocugen, a Pennsylvania-based biopharmaceutical firm, was aiming to launch the vaccine in the United States in the second quarter of 2021, initially with imported shots before beginning production there.
The United States has already authorised COVID-19 vaccines developed by Pfizer/BioNTech, Moderna and Johnson & Johnson for emergency use.
The two-dose COVAXIN has been found to be 81% effective in an interim analysis of late-stage trial data on about 26,000 people in India, Bharat Biotech and Indian Council of Medical Research (ICMR) said this month.
Bharat Biotech said as many as 40 countries are interested in COVAXIN and it has already sought emergency approvals in Brazil and the Philippines. Cracking the US 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 US Food and Drug Administration and planned to seek emergency use authorisation 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 authorised for emergency use in the United States for individuals 16 years and older, with the other two given authorisation 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.
He said Ocugen was expecting more data from Bharat Biotech on COVAXIN, following up on a study by the 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 finalising 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 commercialisation 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 capitalisation, helped by a spike when Bharat Biotech announced its late-stage trial results.
COVAXIN has been given to more than 2 million prioritised 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.