Ocugen plans to sell 100 million doses of India’s Covaxin in the US this year, Shankar Musunuri, CEO of the company told Reuters.
Musunuri said Ocugen was aiming to launch the Indian-developed vaccine in the US in the second quarter of 2021, initially with imported shots before beginning production there.
COVAXIN has been found to be 81 per cent 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.
Cracking the US market would be a significant milestone for the company and India’s vaccine industry.
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 US for individuals 16 years and older, with the other two given authorisation for emergency use in people 18 years and above.
“Like a poliovirus 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 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 finalising US contract- manufacturers for the product.
Ocugen will have the US 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 per cent of the profit.
COVAXIN has been given to more than two 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.
(Edits by EP News Bureau)