The United States Foods and Drug Administration (FDA) has issued a clinical hold on the COVID19 vaccine candidate, BBV152, known as Covaxin outside the United States, Ocugen Inc announced.
The clinical hold has been issued by FDA as it plans to identify specific deficiencies and information on information on how to address those deficiencies, the announcement added.
Ocugen “expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible,” the statement released by the company said.
Covaxin is the indigenous vaccine manufactured using a vero-cell manufacturing platform and developed by Bharat Biotech in collaboration with the Indian Council of Medical Research- National Institute of Virology.
With more than 100 million doses having been administered to adults outside the U.S., Covaxin is currently authorised under emergency use in 17 countries, and applications for emergency use authorisation are pending in more than 60 other countries.
The World Health Organisation has recently added Covaxin to its list of vaccines authorised for emergency use and as many as 110 countries have agreed to mutual recognition of COVID19 vaccination certificates with India that includes vaccination using Covaxin, the statement added.