Lifting the clinical hold will allow Ocugen to continue to assess the vaccine in its ongoing study and potentially support its efforts to achieve EUA or full approval.
Courtesy of Sanchit Khanna/Hindustan Times via Getty Images
The U.S. Food and Drug Administration lifted a second clinical hold on Ocugen’s clinical studies of Covaxin, a vaccine for COVID-19.
The company was in the midst of conducting a Phase II/III clinical trial when the FDA placed the hold last month following Ocugen’s own decision to pause the study. This was due to concerns raised by the World Health Organization regarding an inspection of developmental partner Bharat Biotech International Limited’s manufacturing facility. Lifting the clinical hold will allow the company to continue to assess the vaccine in its ongoing study and potentially support Ocugen’s efforts to achieve Emergency Use Authorization or full approval.
Shankar Musunuri, chairman and CEO of Pennsylvania-based Ocugen, expressed excitement about being able to continue to assess Covaxin, a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. Covaxin has been used extensively across India and other countries and is supported by the World Health Organization as an authorized vaccine against the ongoing COVID-19 pandemic.
Ocugen and Bharat Biotech have been working together since 2020 to develop the two-dose vaccine for use in North America. Ocugen has rights to market the vaccine in the United States, Canada and Mexico.
“The need for delivering an additional, differentiated vaccine option, we believe, remains a priority. Ocugen will now work with study sites to fully resume this clinical development program immediately,” Musunri said in a statement Monday morning. Over the course of the partnership with Bharat Biotech, Musunri has maintained that Covaxin will be an important tool to help fight the COVID-19 pandemic. Earlier this year, Bharat released interim data showing that the vaccine demonstrated a 78% efficacy against mild to moderate infection and 100% against severe COVID-19.
The clinical hold leveled against Ocugen in April came two months after the FDA lifted another Covaxin clinical hold. That hold, which was placed in November 20201, was lifted in February.
Multiple difficulties have beset Ocugen as it has attempted to bring the India-developed vaccine to the United States. Throughout 2021, Ocugen had hoped to secure Emergency Use Authorization from the FDA for Covaxin. However, in the middle of 2021, the FDA recommended that the company seek full approval for Covaxin rather than EUA. In late 2021, the company opted to seek EUA for pediatric patients anyway, citing a need for that patient population.
In the U.S., only the vaccine developed by Pfizer and BioNTech has received authorization for the pediatric population ages 5 to 17, and the FDA rejected Covaxin for this population.
In March, the application for EUA in patients ages 2 to 18 was rejected by the FDA. Following that rejection, Ocugen announced it had shared real-world safety data from 36 million teenagers who have already been treated with Covaxin at the request of the FDA. Additionally, the Malvern company provided the regulatory agency with in vitro data that suggests Covaxin provides “robust neutralization” against the Delta and Omicron variants. That data was submitted to support Ocugen’s pediatric authorization submission.
