Bharat Biotech International Ltd (BBIL) has expanded the scope of its co-development, supply and commercialisation partnership for its Covid-19 vaccine Covaxin with US-based Ocugen Inc. In addition to the US and Canada, Ocugen will also have the exclusive rights for supply and commercialisation of Covaxin in Mexico, thus becoming the exclusive development and marketing partner of BBIL for the entire North America. BBIL said the vaccine continues to be under the WHO Emergency Use Listing (EUL).
However, the supply of Covaxin to these countries will not happen immediately as BBIL has suspended the production of Covaxin for exports due to temporary slowing down of production of Covaxin across its manufacturing facilities to focus on pending facility maintenance, process and facility optimisation activities.
Ocugen said that Covaxin is currently under review by Mexico's COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age.
The suspension of Covaxin exports was in response to the outcome of a WHO (World Health Organisation) inspection on 14–22 March 2022, which identified deficiencies in good manufacturing practices (GMP) at BBIL's Covaxin production units. Following the WHO observation, the U.S. Food and Drug Administration (FDA) had put the Covaxin clinical trial – the Phase 2/3 immuno-bridging and broadening study for Covaxin – carried out by Ocugen in the US on hold.
In an earlier statement, BBIL had said that since all of its existing facilities were repurposed for the manufacture of Covaxin, and with continuous production during the past year, to meet the public health emergency of Covid-19, these upgrades (of production facilities) were due. "Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the Covid-19 pandemic. It has to be stressed that the quality of Covaxin was never compromised at any point in time," the company had said.
The statement had also pointed out that during WHO's inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical.
On its part, the WHO had stated that the risk assessment to date does not indicate changes in the risk–benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concerns exist. "Bharat Biotech has committed to addressing the GMP deficiencies and is developing a corrective and preventive action plan for submission to the Drugs Controller General of India (DCGI) and WHO. In the interim and as a precautionary measure, the company has indicated that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future," the WHO statement said.
