Bharat Biotech Plans Phase IV Study of Covaxin While Ocugen Eyes US EUA

Covaxin_Sanchit Khanna/Hindustan Times via Getty

Sanchit Khanna/Hindustan Times via Getty Images

Shares of Pennsylvania-based Ocugen are down slightly in premarket trading following news that the Covaxin COVID-19 vaccine developed by partner Bharat Biotech of India did not stack up against a vaccine developed by the Serums Institute of India. 

According to the Times of India, Bharat executives have been arguing over the validity of a study conducted by an endocrinologist in India comparing Covaxin with the Serum Institute’s Covishield. Bharat Biotech has claimed the study conducted by Dr. Awadhesh Kumar Singh is flawed. The company said the study is not peer reviewed and was designed to reflect an ad hoc analysis.

Still, Bharat Biotech will conduct Phase IV studies to check real-world efficacy against COVID-19. The company will also only apply for regulatory approval in India following a final analysis of Phase III data, citing a company statement. 

The company said the Phase IV studies would ensure that Covaxin “met every rigorous scientific standard for safety, effectiveness and manufacturing quality needed to support Emergency Use Authorization.” The company added that millions of doses had been administered across India since mid-January, which means they will soon have “credible and sizeable data.”

Final Phase III data is expected in the coming weeks. 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. That 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.

Ocugen is awaiting the Phase III data in order to file for EUA with the U.S. Food and Drug Administration. It is unknown if the planned Phase IV study will delay that filing. Last month, the company submitted a Master File to the FDA ahead of applying for EUA. Shankar Musunuri, chairman, chief executive officer and co-founder of Ocugen, has maintained that Covaxin will be a valuable tool in helping to end the COVID-19 pandemic by increasing vaccine options for the United States and other parts of the world.

According to federal data, about 43% of the U.S. population eligible to receive the preventative medication has been fully vaccinated. 

Last week, Ocugen and Bharat expanded their partnership. Under new terms, Ocugen will also seek EUA in the Canadian market. 

As BioSpace previously reported, Musunuri has held up Bharat’s interim data, as well as in vitro data that shows the vaccine has the potential to be effective against emerging variant strains of the virus. One of the chief strains of concern is the Delta variant, which is predominant in India, as well as parts of England and Scotland. According to recent reports, about 6% of COVID-19 cases in the United States are related to the Delta strain, which is considered more virulent than other COVID variants. 

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