Ocugen hits another snag in bringing its Bharat Biotech-partnered Covid-19 vaccine to the US
Back in July, Ocugen and Bharat Biotech unveiled some Phase III data suggesting their Covid-19 vaccine, Covaxin, was 77.8% effective at preventing overall disease in India. They’re now looking to launch an immuno-bridging study to see if those numbers hold up in the US — but on Friday, the FDA said not so fast.
Regulators have placed a clinical hold on the partners’ IND, Ocugen shared on Friday. Ocugen’s stock $OCGN sank 9% on the news Friday, but was up almost 7% in pre-market trading on Monday.
“The FDA plans to identify the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies,” the Malvern, PA-based company said in a statement. “The Company expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA in an effort to resolve its questions as promptly as possible.”
The news comes just a few weeks after Ocugen filed for emergency use authorization of the Bharat Biotech-partnered shot for just pediatric use based on an immuno-bridging study conducted in India.
Covaxin, a whole-virion, inactivated vaccine, was developed by Bharat Biotech along with the Indian Council of Medical Research. The World Health Organization granted it an emergency use listing earlier this month, stating that the jab is “extremely suitable for low- and middle-income countries due to easy storage requirements.”
In July, Bharat announced that the vaccine was 77.8% effective against Covid-19 of any severity, and 93.4% effective against severe disease in a Phase III trial with more than 25,000 participants in India. Fewer than 0.5% of patients experienced severe side effects, the Indian biotech said at the time.
Earlier this year, Ocugen announced plans to file for an EUA in the US in June. But when June rolled around, the company said it decided to pursue a biologics license application instead, upon recommendation by the FDA. At the end of October, Ocugen filed an IND to conduct a Phase III immuno-bridging study in “several hundred” US adults who’ve never been vaccinated, or received two doses of an mRNA vaccine at least six months prior.
Just a week later, the company submitted an EUA for use in kids ages 2 to 18 based on another immuno-bridging study conducted in India. According to Ocugen, an immuno-bridging study showed that neutralizing antibody responses in the pediatric group were equivalent to those seen in adults.
“Our research suggests that people are seeking more choices when selecting a vaccine, especially for their children,” CEO Shankar Musunuri said. “Having a new type of vaccine available will enable people to discuss with their child’s physician the best approach for them to lower their child’s risk of contracting COVID-19.”
The clinical hold may not be a good sign for Ocugen’s pediatric EUA, though we’ll have to wait and see.