Six weeks after slapping a clinical hold on a trial of Ocugen’s COVID-19 vaccine, the FDA has lifted (PDF) it. That’s the good news for the Malvern, Pa. company, which has partnered with India’s Bharat Biotech on the shot known commercially as Covaxin.
But the flip side for Ocugen is the declining demand for COVID vaccines in the United States. If Ocugen ever secures regulatory approval for Covaxin, will anyone want it—especially given the current surplus of available COVID jabs?
On April 12, the FDA put a hold on Ocugen’s phase 2/3 immuno-bridging study of Covaxin, designed to show that it could protect people in the U.S. as effectively as shown in trials in India. The action came 10 days after the World Health Organization suspended the supply of the drug following an inspection that identified deficiencies in good manufacturing practices (GMP).
With those manufacturing problems addressed, Ocugen is now free to resume the trial. Ocugen still believes that it can find a market in the U.S., where many are hesitant to use the mRNA vaccines of Pfizer and Moderna.
“The need for delivering an additional, differentiated vaccine option, we believe, remains a priority,” Ocugen CEO Shankar Musunuri said in a statement.
Getting Covaxin through the regulatory process has proven a challenge in the U.S. The FDA also had Covaxin on hold from November to February. Then in March, the FDA rejected Ocugen’s application for emergency use in people 2 to 18. It was the company’s hope that the shot might be an attractive option for children—where vaccine hesitance among parents runs particularly high.
More than 350 million doses of Covaxin have been administered around the world. It is the second-most used shot in India and is approved in 24 other countries.
Bharat is seeking approval for the shot in more than 60 other countries, even amid declining demand for COVID-19 vaccines worldwide. Europe recently delayed deliveries from Pfizer and BioNTech by three months. Earlier this month, Bloomberg reported that Johnson & Johnson’s vaccine manufacturing partner in South Africa, Aspen, had received no orders.