Ocugen On Track to Bring Bharat Biotech's COVAXIN to US Market With Strong Data


Ocugen’s plan to bring a COVID-19 vaccine developed by India-based Bharat Biotech later this year remains on track following an interim analysis of Phase III data that shows the vaccine demonstrated a 78% efficacy against mild to moderate infection and 100% efficacy against severe COVID-19.

This is 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. Ocugen and Bharat Biotech have been working together since December to develop COVAXIN, an advanced stage whole-virion inactivated vaccine. COVAXIN, a two-dose vaccine, has already received authorization in India for people ages 12 and above.

Shankar Musunuri, chairman and chief executive officer of Pennsylvania-based Ocugen, said they continue to be excited about the “compelling second interim results” of the Bharat Biotech study. 

“We believe that COVAXIN can help change the course of this pandemic by preventing severe COVID-19 disease including hospitalizations by 100% as well as significantly limit the spread of asymptomatic COVID-19 infections based on efficacy shown to date. We are dedicated to being a part of the solution to save lives from COVID-19 by bringing COVAXIN to the U.S. market,” Musunuri said in a statement.

The second interim analysis is based on recording more than 87 symptomatic cases of COVID-19 among the trial of 25,800 patients. Due to the recent surge of COVID-19 in India, 127 symptomatic cases were recorded, which resulted in the estimate of vaccine efficacy of 78% against mild, moderate, and severe COVID-19 disease. 

Cases of COVID-19 are surging in India mainly due to the number of large gatherings related to recent religious festivals and political assemblies. Just today, India reported more than 332,000 new cases of COVID-19. According to CNBC, India has posted the highest number of daily cases for several days. 

The Phase III trial will be continuing to its pre-planned conclusion, Ocugen said. The efficacy against asymptomatic COVID-19 infection was 70%, based on a subgroup of approximately 8,000 participants who visited the clinical trial site each month for an RT-PCR test.

In March, Musunuri said the company was planning to meet with the U.S. Food and Drug Administration to press for Emergency Use Authorization of COVAXIN based on the interim data. In the latest announcement, there was no mention of a potential meeting with the regulatory agency. 

Musunuri said COVAXIN will be an essential tool to help the nation continue its vaccination efforts against COVID-19. 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. The vaccine developed by Johnson & Johnson is currently paused in the United States while health authorities investigate cases of clotting in a handful of the seven million people who have received the preventative medication.

Bruce Forrest, a member of Ocugen’s vaccine scientific advisory board, touted the safety and efficacy of the COVAXIN drug. He said those results are “remarkable” due to the presence of multiple variants of COVID-19 that were present during the Phase III study conducted by Bharat Biotech.

“This vaccine is based on a proven technology platform and the company plans to consider clinical development in special populations such as children,” Forrest said in a statement.

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