Ocugen Announces FDA Clinical Hold Removal for Phase 2:3 COVAXIN BBV152 Clinical Trial

Ocugen Announces FDA Clinical Hold Removal for Phase 2/3 COVAXIN (BBV152) Clinical Trial


Biotechnology company Ocugen, Inc. (NASDAQ: OCGN) announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold that was recently placed on the Ocugen COVAXIN™ (BBV152) Phase 2/3 clinical trial known as OCU-002 with dosing to resume immediately for those enrolled in the study. COVAXIN (BBV152) is an inactivated COVID-19 vaccine that uses adjuvant Alhydroxiquim-II designed to boost immune response and longer-lasting immunity.

The study is a randomized, observer-blind, placebo-controlled immuno-bridging, and broadening study designed to demonstrate the equivalence of the immune response between participants enrolled in Phase 3 efficacy trial in India and demographically diverse healthy adult participants in the US which matched in age and vaccine formulation setting to whom those efficacy results are extrapolated; and to assess the broadening of the BBV152 in participants who previously received two shots of messenger ribonucleic acid (mRNA) COVID-19 vaccine at least 6 months earlier or one-shots of viral vector J&J/Janssen COVID-19 vaccine at least 2 months earlier. Safety and tolerability evaluation is a secondary endpoint.

About Ocugen

Biotechnology company Ocugen, Inc. has a focus on discovery, development, and commercialization oo the diverse group of medicine known as biologicals including vaccines and novel gene therapies designed to improve patient health and offer new hope for individuals throughout the world with hard-to-treat disease.

The company is working to make an impact through innovation and taking chances in new frontiers. Ocugen believes in taking science to new levels as they aim to serve patients. The company’s breakthrough modifier gene therapy platform is cited to have the potential to treat multiple diseases with one single drug. Ocugen is also currently working to advance research across other therapeutic areas offering new treatment options for people with unmet medical needs.

About COVAXIN (BBV152)

COVAXIN (BBVI52) is a trademarked investigational COVID-19 vaccine candidate developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).

The highly purified inactivated vaccine utilizes a vero cell manufacturing platform.

Vaccination is recommended for people living with conditions that have been identified as increasing the risk of severe COVID-19, including cardiovascular disease, respiratory disease, diabetes, liver disease and obesity.

These conditions can make it difficult for someone to breathe, circulate blood properly, or process sugar, which can lead to more serious illness if they contract coronavirus.

The vaccine can be offered to people who have had COVID-19 in the past. Available data shows that symptomatic reinfection is unlikely for up to 6 months after infection. Those with documented infection may therefore choose to delay vaccination to nearer the end of this period, especially when vaccine supply is limited, to allow others priority for vaccination.

However, this does not mean that the vaccine is unnecessary for those who have had COVID-19; it simply means that they may have a lower priority when it comes to receiving the vaccine.

COVAXIN (BBV152) Previous Clinical Holds

COVAXIN has had two previous holds placed by the U.S. regulator regarding Ocugen’s investigational new drug.

The first clinical hold for COVAXIN occurred in November 2021 upon the announcement by Ocugen where the company reported the delay and said it was awaiting word from the FDA about how to address “deficiencies” in the application. The hold was lifted a in February 2022.

The company has also requested pediatric approval in the U.S., stressing that its traditional-style vaccine is similar to the shot commonly provided to children to defend against polio however that request was denied in March 2022 by the FDA.

Covaxin was sanctioned by the WHO late last year and is currently approved in 14 countries including India, Malaysia, Mexico and the Philippines. Ocugen reported that over 125 Million doses of the shot were distributed and administered during 2021.

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