Ocugen Hits A Stumbling Block for Its COVID-19 Vaccine Candidate

The FDA has placed a clinical hold on Ocugen’s Investigational New Drug (IND) application for BBV152, the company’s COVID-19 vaccine candidate known as Covaxin outside the U.S.

The company didn’t disclose much information, saying only that it expects to hear from regulators soon about “the specific deficiencies that are the basis for clinical hold and information on how to address those deficiencies.”

In June, FDA denied Ocugen an Emergency Use Authorization, saying that the company needed to conduct a U.S. trial (DID, June 16).

The news of a clinical hold comes on the heels of two recently published studies with divergent efficacy findings. On Nov. 11, The Lancet reported that the vaccine was 77.8 percent effective against lab-confirmed COVID-19 infection. The phase 3 trial enrolled 25,798 subjects randomized to the vaccine or placebo. Covaxin was 63.6 percent effective against asymptomatic disease and 65.2 percent effective against Delta infections.  Efficacy against severe disease was very high, at 93.4 percent

But on Nov. 23, The Lancet published another study with sharply different findings. The real-world observational study, conducted among 2,136 fully vaccinated hospital healthcare workers, found that efficacy hovered around 50 percent (DID, Nov. 29).

Despite the lower overall efficacy, the study did confirm Covaxin’s efficacy against other measures: severe disease (93.4 percent), symptomatic infection (63.6 percent) and Delta variant infection (65.2 percent). — Michele G. Sullivan