2 min read.Updated: 02 Feb 2021, 10:00 PM ISTLeroy Leo
Ocugen will have the commercial rights to the vaccine candidate in the US and will be responsible to conduct clinical trial and get emergency use authorisation EUA from the US FDA
New Delhi: Bharat Biotech International Ltd on Tuesday announced that it has signed a pact with Ocugen Inc, allowing the US-based biopharmaceutical firm to co-develop, supply, and commercialize the Indian vaccine maker’s Covid-19 vaccine Covaxin in the US market.
Under the terms of the agreement, Ocugen will have the commercial rights to the vaccine candidate in the US and will be responsible to conduct clinical trial and get emergency use authorisation (EUA) from the US Food and Drug Administration.
After securing the EUA, it can commercialise the wholly-inactivated virus vaccine in the US market, and retain 45% of the profits that is made, with the rest going to the Indian firm.
Bharat Biotech will supply initial doses to be used in the US upon receipt of EUA and also support the technology transfer for manufacturing in the US.
In preparation for the development of Covaxin in the US, Ocugen’s management and vaccine scientific advisory board have started discussions with the US FDA and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to secure EUA and, eventually, get a biologics license application approval in the US for the vaccine.
The US-based firm is also in active discussions with manufacturers in the US to produce a significant number of doses of Covaxin to support the country’s immunization program.
“Our goal for all vaccines developed at Bharat Biotech is to provide global access... With the recent progression of Covaxin use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring Covaxin to the US market," Bharat Biotech chairman and managing director Krishna Ella said.
Covaxin had received an emergency licensure from the Drugs Controller General of India V.G. Somani last month, following which administration of the vaccines started on 16 January.
Data on the vaccine’s phase 1 and 2 trials were recently published in the peer-reviewed Lancet journal last month, and the company has also shown data of laboratory studies, which showed that the vaccine could provide protection against the mutant strain of the novel coronavirus.
However, a major controversy about the vaccine has been that the company has not yet got efficacy data from its phase 3 trial, which is ongoing. In a post-Budget interaction on Monday, Ella had said that the company expects the first interim reading of efficacy data to be out in March.