On Tuesday, Bharat Biotech International Ltd announced that it has signed a pact with Ocugen Inc, enabling the US-based biopharmaceutical company to co-develop, supply and sell the Covid-19 vaccine Covaxin from the Indian vaccine manufacturer in the US market.
Ocugen will have the commercial rights to the vaccine candidate in the US under the terms of the agreement and will be responsible for performing a clinical trial and securing emergency use approval (EUA) from the US Food and Drug Administration.
After acquiring the EUA, the fully inactivated virus vaccine can be sold on the US market and 45 per cent of the profits produced can be kept, with the remainder going to the Indian company.
Upon receipt of the EUA, Bharat Biotech will supply initial doses to be used in the US and will also help technology transfer for development in the US.
In preparation for the production of Covaxin in the U.S., the Scientific Advisory Board of Ocugen’s Management and Vaccine has begun negotiations with the U.S. FDA and the Biomedical Advanced Research and Development Authority (BARDA) to establish a regulatory roadmap to secure the EUA and ultimately gain the approval of a biologics license application for the vaccine in the U.S.
The US-based company is also engaged in active negotiations with US suppliers to manufacture a large number of doses of Covaxin to help the country’s immunization program.
“Our objective for all vaccines produced at Bharat Biotech is to provide access to the world… With the recent progression of EUA use of Covaxin in India, I am sure that we will be able to work with Ocugen to build a strategy to introduce Covaxin to the US market,” said Krishna Ella, Chairman and CEO of Bharat Biotech.
Last month, after administration of the vaccines, began on 16 January, Covaxin received an emergency license from the Drug Controller General of India, V.G. Somani.
Data on phase 1 and 2 vaccine trials were recently published last month in the peer-reviewed Lancet journal, and the company also announced data from laboratory studies showing that the vaccine could provide safety against the novel coronavirus mutant strain.
A major controversy regarding the vaccine, however, has been that the firm has not yet received efficacy results from its ongoing phase 3 trial. Ella had said on Monday in a post-Budget conversation that the organization expects the first interim reading of efficacy data to be out in March.
