Ocugen submitted a “Master File” to the U.S. FDA for COVAXIN, the vaccine that has already received authorization in India for people ages 12 and above.
Update: Ocugen faces a major slowdown for its COVID-19 vaccine as FDA Recommends BLA. Read more about it here.
Pennsylvania-based Ocugen has moved one step closer to bringing a COVID-19 vaccine developed by India-based Bharat Biotech into the United States market. The company submitted a “Master File” to the U.S., Food and Drug Administration, a necessary step ahead of seeking Emergency Use Authorization.
Ocugen and Bharat Biotech have been working together since December to develop COVAXIN, a two-dose vaccine that has already received authorization in India for people ages 12 and above.
“We continue to believe this vaccine is a critical tool to include in our national arsenal to fight this pandemic. The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application,” Shankar Musunuri, Chairman, Chief Executive Officer and co-founder of Ocugen, said after the Master File was submitted.
Before the EUA can be sought in the United States, Ocugen must await the final results of Bharat Biotech’s Phase III trial of its COVAXIN vaccine candidate. This year, Bharat released interim data showing the vaccine demonstrated a 78% efficacy against mild to moderate infection and 100% efficacy against severe COVID-19. The interim analysis
That interim data was the second interim analysis of the COVAXIN vaccine candidate. In the second analysis, the vaccine’s efficacy against mild to moderate infection slipped a little from 81% revealed in the first interim analysis.
Earlier this month, during the company’s quarterly financial report, Musunuri said the company is dedicated to ending the COVID-19 pandemic by bringing COVAXIN into the U.S. market. He pointed to the second interim analysis and positive in vitro data that shows the vaccine has the potential to be effective against emerging variant strains of the virus.
“We continue to make progress toward Emergency Use Authorization for COVAXIN while also considering clinical development in special populations, such as children, as well as booster doses,” Musunuri said in a statement.
Musunuri said COVAXIN would be an important tool to help the nation continue its vaccination efforts against COVID-19. Currently, there are three vaccines authorized for use in the United States, two mRNA vaccines developed by Pfizer and BioNTech and Moderna, and a Johnson & Johnson vaccine. According to federal data, about 287 million vaccine doses have been given, with 131 million being fully vaccinated.
Over the course of its clinical development, Bharat Biotech provided in vitro data suggesting that COVAXIN can show efficacy in neutralizing the double mutant India variant, the U.K. variant, and the Brazil variant.
