NEW DELHI: Hyderabad-based Bharat Biotech on Monday said an emergency use authorization (EUA) application for COVID-19 vaccine Covaxin for use in children in the 2-18 years age group has been made to the Mexican health regulator.
It also said they had expanded its US market co-development, supply, and commercialisation agreement for its vaccine with Ocugen, a biotechnology company, to include Mexico, thus giving the US company the commercialisation rights for the entire North America.
In a statement, the pharma company said Ocugen, a NASDAQ listed company, and Bharat Biotech "have entered into an amendment to their co-development, supply, and commercialization agreement to expand Ocugen's exclusive territory to include the commercialization of Covaxin in Mexico. This gives the US company Covaxin commercialization rights for all of North America".
Covaxin, which has already been authorised for emergency use in adults by health regulators in Mexico, has been submitted for Emergency Use Authorisation (EUA) for children aged 2-18 years, it added. "We are excited to commercialize Covixin in Mexico, as authorities there have made conquering this pandemic a major priority," said Ocugen chairman and co-founder Dr Shankar Musunuri.
He said that they met Mexico's secretary of foreign affairs, Marcelo Ebrard, in Delhi. "We are delighted to announce our partnership with Ocugen for Mexico, along with the United States and Canada. Covaxin is a safe and productive inactivated vaccine for all age groups, as evident from its data from the global introduction. We fully support team Ocugen in our endeavor to expedite technology transfer activities towards commercial-scale manufacturing of Covaxin in North America," said Bharat Biotech chairman and MD Dr Krishna Ella.
It added that the license extension between Ocugen and Bharat Biotech concerning commercialisation in Mexico includes the same profit share structure as in the US.
The announcement came after the World Health Organisation (WHO) on April 2 announced that it had suspended the supply to United Nations agencies of COVID-19 vaccine Covaxin after its inspectors identified good manufacturing practice deficiencies in the pharma company's pharma plants.