Covaxin maker Bharat Biotech’s North American partner Ocugen has decided that development of the Indian company’s COVID-19 vaccine is not commercially viable in the light of U.S. Food and Drug Administration’s decision to pull the plug on monovalent vaccines.
“Ocugen has concluded that the development of Covaxin in North America is not commercially viable as a result of the FDA’s recent decision around monovalent vaccines,” the U.S. firm said in a business update recently.
The update, which accompanied Ocugen’s first-quarter results, came in the backdrop of the U.S. FDA last month announcing that monovalent COVID-19 vaccines produced by Moderna and Pfizer-BioNTech were no longer authorised for use in the U.S. This was in line with the January 26 decision of the FDA’s Vaccines and Related Biological Products Advisory Committee, which unanimously voted to recommend harmonising the strain composition of COVID-19 vaccines used in the U.S.
Declaring that the two vaccines were no more authorised, the FDA also amended the emergency use authorisations for the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines. It said the action includes authorising the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals six months of age and older, including for an additional dose or doses for certain populations.
Also, the World Health Organization had earlier this month said COVID-19 was no longer a public health emergency of international concern.
Interestingly, Ocugen had in early January announced positive results from Phase 2/3, observer-blind, immuno-bridging and broadening study of Covaxin in the U.S. “Given a portion of the public remains hesitant to receive mRNA vaccines, this investigational COVID-19 vaccine candidate [Covaxin], which relies on a well-established approach to vaccine development and manufacturing, may provide an important additional vaccine option,” its Chairman, CEO and co-founder Shankar Musunuri had said at the time.
Ocugen was responsible for conducting the trials and commercialisation of Covaxin in the U.S, but the path has not been easy with the FDA putting the trial on hold for a few weeks in April 2022 in the wake of WHO suspending supply of vaccine through UN procurement agencies. The WHO had cited the outcome of an inspection of Bharat Biotech facilities and the need to conduct process and facility upgrades to address identified deficiencies in good manufacturing practices as reason for the suspension.
When an update on Covaxin, in the U.S., was sought, a Bharat Biotech spokesperson said the company preferred not to comment.
