US FDA issues clinical hold on Ocugen’s IND to evaluate Covid-19 vaccine candidate, Covaxin

Malvern, PennsylvaniaMonday, November 29, 2021, 17:00 Hrs  [IST]

Ocugen, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that the US Food and Drug Administration (FDA) has issued a clinical hold on the company’s Investigational New Drug application (IND) to evaluate the Covid-19 vaccine candidate, BBV152, known as Covaxin outside the United States.

The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies. The Company 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.

Covaxin (BBV152) is an investigational vaccine candidate product in the US. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). Covaxin is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.

With more than 100 million doses having been administered to adults outside the US, Covaxin is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added Covaxin to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using Covaxin. The trade name Covaxin has not been evaluated by the FDA.

As recently published in, The Lancet, Covaxin (BBV152) demonstrated 77.8% overall efficacy, 63.6% efficacy against asymptomatic disease and 65.2% efficacy against the Delta variant in the phase 3 clinical trial of nearly 25,800 participants. Adverse events reported in the trial were low, with 12.4% of subjects experiencing commonly known side effects and less than 0.5% of subjects experiencing serious adverse events, which is consistent with data from other vaccines that apply whole-virion technology. Both adverse events and serious adverse events reported in the vaccine group were reported at similar rates to the placebo group. The trial was conducted in India and sponsored by Bharat Biotech.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from Covid-19.

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications.