Ocugen turns to BLA path in the US for COVID-19 vaccine candidate

By Rachel Arthur

- Last updated on GMT


Related tags COVID-19 vaccine

Ocugen will pursue submission of a biologics license application (BLA) in the US for the COVID-19 vaccine candidate, COVAXIN, rather than a EUA application. The company believes that the differentiated vaccine has the potential to address variants, as well as planning to undertake paediatric and booster trials.

COVAXIN, India's COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The inactivated vaccine is currently being administered under emergency use authorizations in 13 countries; with applications for use pending in more than 60 additional countries.

Up to 2020, Pennsylvania-headquartered Ocugen’s focus was primarily on gene therapies to cure blindness diseases. However, as the pandemic hit it decided to get involved in vaccine development.

“When the pandemic was raging in the country, we did not want to sit on the sidelines,”​ the company told BioPharma-Reporter. “Given the significant technical expertise and background (our CEO was formerly at Pfizer running the global technical operation for the Prevnar vaccine and has an extensive network of vaccine experts), we were surprised that the traditional type of vaccine was missing from the US vaccine options.

“Upon scanning the landscape, we noticed the incredible work done by Bharat Biotech to develop a COVID-19 vaccine. Leveraging a prior working relationship with Bharat, we struck a deal to bring COVAXIN to the US and Canadian markets to fight this pandemic.”

Ocugen points to data from trials to date: Phase 3 interim results show 78% efficacy for the vaccine, as well as being 100% effective against severe disease. Furthermore, “COVAXIN has demonstrated its potential effectiveness against all the major variants including the delta variant which now starting to spread in the US,”​ according to the company.

Regulatory pathways

Last week Ocugen announced that, upon recommendation from the U.S. Food and Drug Administration (FDA), it would pursue submission of a BLA for COVAXIN rather than a EUA. It will have to submit additional information and data to the FDA, and anticipates that data from an additional clinical trial will be required to support the submission.

This will extend the timelines for the vaccine: although the company would not specify what the timeframe now looks like.

Meanwhile, in Canada, Ocugen recently secured exclusive rights to commercialize the vaccine in this country and has initiated discussions with Health Canada for regulatory approval: planning for expedited authorization.

So why pursue the vaccine in North America when other heavyweights are already being rolled out in mass vaccination campaigns? The company points to the unknowns about what will be needed to protect populations in the long term.

COVAXIN is a differentiated vaccine with the potential to address many variants,"​ the company told us. "The vaccine candidate has a very good safety profile as demonstrated by the clinical trials in India as well as mass immunization that is underway in India. We are planning to undertake paediatric and booster trials as well as, we believe, the risks of COVID-19 has not abated.”

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