Ocugen to seek emergency-use nod for Covaxin in US market

safari2021 · May 5, 2021

Covaxin demonstrates potential effectiveness against different variants, says study
Ocugen, the US partner of Bharat Biotech for its Covid-19 vaccine Covaxin, is set to seek the US Food and Drug Administration’s nod for emergency-use authorisation of the vaccine in the US market.
The Ocugen team has submitted a comprehensive drug master file with the FDA, and is currently diligently preparing the EUA application, according to Shankar Musunuri, Chairman of the Board, CEO and and co-founder of Ocugen.

In February, Hyderabad-based Bharat Biotech and Ocugen entered into a pact, according to which the latter will co-develop, supply, and commercialise Covaxin.
Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialisation for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of EUA.

According to industry sources, Covaxin has been receving good reviews in the US by experts, especially after a remark by White House chief medical adviser Anthony Fauci that Covaxin can neutralise the B1617 variant of coronavirus.
Citing a study by ICMR-National Institute of Virology, Ocugen, on Monday, said that Covaxin “demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2.”.
“As previously disclosed, a study conducted by ICMR also suggested that Covaxin was effective against the UK variant, as well as the Indian double-mutant variant,” it said.
Domestic market
In the domestic market, the reach of Covaxin is also widening. Global healthcare provider IHH Healthcare has entered into a partnership with Bharat Biotech to provide Covaxin at Gleneagles Global Hospitals in three locations in India.
“Three of the IHH Healthcare institutions in India – BGS Gleneagles Global Hospitals, Kengeri, Bengaluru; Gleneagles Global Health City, Chennai; and Gleneagles Global Hospitals, Hyderabad, will foray into this initiative and also widen the vaccination drive for the younger population,'' IHH announced on Tuesday.
The vaccination drive, for 18-44 years, will extend to other hospitals within the network later in the month.
This partnership comes at the backdrop of the Government of India’s announcement of a liberalised and accelerated Phase 3 Strategy of Covid-19 vaccination from May.
The partnership between Gleneagles Global Hospitals and Bharat Biotech is a focussed approach to serve communities across Bengaluru, Chennai, Hyderabad, and the rest of the cities within the network of hospitals.