The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.
Ocugen just hit a major speed bump in what was expected to be its final turn in the COVID-19 vaccine race. The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full Biologics License Applications (BLA) approval.
The announcement comes right as Ocugen was finalizing its EUA application. The FDA decided for the company by recommending a BLA submission instead of a EUA for Covaxin. The agency also requested additional information beyond what was submitted. No further details on the data needed were given.
Ocugen’s decision to join the race for a COVID vaccine was a bit of a surprise. A player in the ocular gene therapy world, the company was facing delisting from the NASDAQ in December of 2019. Joining forces with Indian vaccine developer Bharat Biotech bolstered Ocugen’s to stay in the game.
Yesterday’s news may be a glimpse into why the FDA is recommending a BLA instead of the EUA fast lane the three vaccines currently approved in the US took.
A study performed by endocrinologist Dr. Awadhesh Kumar Singh showed Ocugen-Bharat’s Covaxin did not stack up against a competing vaccine developed by the Serums Institute of India. Bharat Biotech questions the study’s validity and is launching a Phase IV study of real-world efficacy against COVID-19.
According to the company, the Phase IV study would ensure that Covaxin “met every rigorous scientific standard for safety, effectiveness and manufacturing quality needed to support Emergency Use Authorization.”
With millions of doses already given across India, sizeable data is anticipated soon.
Today’s announcement certainly draws out the timeline for approval for Ocugen. The FDA can take six to ten months to approve a BLA. However, the current pandemic has shown they will stomp the gas for our current pandemic once the evidence of safety and efficacy is proven.
Ocugen’s CEO, Dr. Shankar Musunuri, said, “Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing COVAXIN™ to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term.”
While final Phase III data is still coming, a second interim report shows a 78% efficacy against mild to moderate infection and 100% efficacy against severe COVID-19. The trial was the largest ever conducted in India, with 25,800 volunteers. Covaxin only needs regular refrigeration temperatures and is shipped ready-to-use, vital features for countries with limited access.
This morning, India reported more than 6,000 COVID-19 deaths in a 24-hour period, the highest ever in the world. Less than 6% of the country’s massive population is fully vaccinated.
Although securing a EUA for use in the US is now out of the picture, Ocugen will continue to move forward to secure full approval from the FDA, as well as a EUA in Canada. The company expanded rights for commercialization to include Canada earlier this month.
