The US Food and Drug Administration (FDA) has placed a clinical hold on Ocugen’s Investigational New Drug application (IND) to initiate a Phase III clinical trial of its Covid-19 vaccine candidate, BBV152.
Called Covaxin outside the US, the vaccine was developed by Bharat Biotech in partnership with the Indian Council of Medical Research – National Institute of Virology.
Bharat Biotech and Ocugen entered a binding letter of intent in December 2020 to co-develop the vaccine for the US market.
Made using a Vero cell manufacturing platform, Covaxin is a purified and inactivated vaccine.
This October, Ocugen filed an IND application with the FDA to conduct the trial which planned to assess the safety and tolerability of the vaccine in the US participants.
Ocugen noted that the FDA intends to detect the peculiar deficiencies that led to the clinical hold of the trial and data on how to rectify them.
The company anticipates receiving an official written communication from the FDA that comprise further data and intends to cooperate with the agency to answer their queries soon.
Presently authorised for emergency use in 17 countries, the vaccine obtained World Health Organization (WHO) emergency use listing in November.
More than 100 million doses of the vaccine were given to adults outside the US while as many as 110 nations have agreed to recognise Covid-19 inoculation certificates with India that comprises vaccination with Covaxin.
In the Phase III Indian trial that enrolled approximately 25,800 subjects, the vaccine was found to have overall efficacy of 77.8% and 63.6% and 65.2% efficacy against asymptomatic Covid-19 and the Delta variant of SARS-CoV-2, respectively.
Minimal side effects were reported in the trial with 12.4% of participants experiencing common adverse events (AEs) and fewer than 0.5% of people having serious AEs.
Earlier this month, Ocugen submitted an application to obtain FDA emergency use authorisation for the vaccine usage in children aged two to 18 years.