Ocugen to Seek EUA for India-Developed COVID-19 Vaccine in the United States
Pennsylvania-based Ocugen has struck a deal to sell 100 million doses of a COVID-19 vaccine India’s Bharat Biotech in the United States later this year.
In an interview with Reuters, Ocugen Chief Executive Officer Shankar Musunuri said it intends to launch the vaccine in the U.S. in the second quarter of this year, pending regulatory authorization. If the plan comes to fruition, the first doses will be imported from India and then subsequently manufactured in the U.S. by Ocugen. The two companies first announced plans for the deal in February.
Ocugen and Bharat Biotech have been working together since December to develop COVAXIN, an advanced stage whole-viron inactivated vaccine. COVAXIN, a two-dose vaccine, has already received authorization in India for people ages 12 and above. In February, more than 30 million doses of COVAXIN had been administered to health professionals and front-line workers in India.
When the companies partnered in December, Ocugen said it had assembled a Vaccine Scientific Advisory Board to evaluate the clinical and regulatory path to approval in the U.S. market.
Earlier this month, Bharat announced interim results of its Phase III trial that showed efficacy of 81% for its COVID-19 vaccine. The interim data analysis was based on 43 recorded cases of the disease in the trial of 25,800 people. So far, the U.S. Food and Drug Administration has authorized three different vaccines in the U.S. developed by Moderna, Pfizer and BioNTech and most recently, Johnson & Johnson.
The FDA has held off authorizing AstraZeneca’s vaccine, initially due to concerns over efficacy data. Multiple countries in Europe and Asia that previously authorized the AstraZeneca vaccine have now paused vaccination efforts with that medication due to concerns over clotting issues.
“The evaluation of COVAXIN has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN may offer an important option to protect lives across America,” Musunuri said in a statement last month when Ocugen and Bharat announced the commercialization agreement.
Ocugen and Bharat hope to become the fourth vaccine authorized in the United States. According to Reuters, the companies will meet with the U.S. Food and Drug Administration in April to press for EUA based on the data from the ongoing Phase III study. Ocugen’s Musunuri said the FDA is “fine with the way the interim analysis is being done” and believes that will make the path toward authorization easier.
Musunuri said COVAXIN had the potential to work against COVID-19 variants and Ocugen could initially focus on children as it was likely to be safe for those over the age of 12, Reuters added.
“Like a polio virus given to babies, this could be safe for all children, high-risk groups, pregnant women and people with comorbidities,” Musunuri said of COVAXIN, according to the report.