Ocugen and Bharat Biotech extend Covaxin deal to Mexico

Ocugen Inc, Bharat Biotech's Covaxin partner in the US and Canada, has announced that it would also commercialize the Covid-19 vaccine in Mexico.

With the amended deal, Pennsylvania based Ocugen's Covaxin rights now encompass all of the North American continent.

COVAXIN is already authorized for emergency use in adults by the health regulators in Mexico, and has been submitted for Emergency Use Authorization for children aged 2-18 years, Ocugen Inc and Bharat Biotech said in a statement on Monday.

Last year, Bharat Biotech and Ocugen Inc had announced “a definitive agreement” to co-develop, manufacture, supply, and commercialize Covaxin for the United States and Canada markets. As per the deal, Ocugen and Bharat Biotech would share the profits from Covaxin sale in a 45:55 ratio.

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However, the US Food and Drug Administration last week put on hold the Phase-2/3 clinical trials of Covaxin in the US.

The USFDA call was based on “the US firm's decision to voluntarily implement a temporary pause in dosing participants of the jab, following the WHO's observations on Covaxin plants in India.”

On 2 April, the World Health Organisation revealed that it has suspended the supply of Covaxin through the UN procurement agencies, and “recommended that countries using the vaccine take action as appropriate.”

The suspension is following WHO inspection of Bharat Biotech's Covid-19 vaccine manufacturing facilities in March, “and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP).”

Bharat Biotech said that it is 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 Hyderabad based 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 had said in a statement.

However, the world health body said that “the risk assessment to date does not indicate change in the risk–benefit ratio.” The data, available to WHO, indicate the vaccine is effective and no safety concerns exist

WHO had issued Emergency Use Listing for Covaxin in November.

“We’re excited to commercialize COVAXIN in Mexico, as authorities there have made conquering this pandemic a major priority. After meeting with Mexico’s Secretary of Foreign Affairs, Marcelo Ebrard, in Delhi, we are encouraged by the role COVAXIN can play in Mexico’s continuing efforts to defeat the Covid-19 pandemic. COVAXIN is currently under review by COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) for emergency use among children between 2 and 18 years of age, and Ocugen is prepared to collaborate with the public health community to help their efforts,” said Dr Shankar Musunuri, Chairman of the Board, Chief Executive Officer and Co-founder of Ocugen, Inc on Monday.

BBV152 or Covaxin is co-developed by Bharat Biotech and the Indian Council of Medical Research.

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