Ocugen climbs on phase 3 COVID vaccine data, hitting back at delta variant

After seeing its stock fall consistently over the past few months, Ocugen and partner Bharat Biotech have posted some encouraging data from their pandemic vaccine Covaxin.

The latest look from its late-stage of test of the virion-inactivated COVID-19 vaccine, which already has restricted emergency use in India, saw vaccine efficacy in mild, moderate and severe COVID-19 disease of 77.8%, with efficacy against severe COVID-19 disease alone of 93.4%.

It also hit 65.2% efficacy against the highly transmissible delta (B.1.617.2 or “Indian”) variant, which is currently gaining traction around the world and will likely become the dominant strain by year-end across most countries.

This puts it broadly in line with the efficacy seen from Pfizer and BioNTech’s mRNA vaccine, with Israeli scientists this week saying the shot was around 64% effective in preventing both infection and symptomatic disease in the delta variant in the country, a fall of around 30% in efficacy terms from the previous alpha (or Kent) variant.

The data from a preprint (and the caveats that always brings) were from across 25,798 participants between 18 and 98 years of age in India, including 2,750 over the age of 60 and 7,065 with comorbidities.

Drilling down into the numbers, in all, 130 COVID-19 cases were observed: 24 in the vaccine group and 106 in the placebo group. Sixteen severe cases were observed: one in the vaccine group and 15 in the placebo group.

Ocugen’s partner Bharat also said the data showed Covaxin was the first COVID-19 vaccine to report efficacy against asymptomatic infections, which was based on PCR testing.

Exact details on safety were not shared, though Ocugen said adverse events “were low,” with 12.4% of subjects experiencing “commonly known side effects” and less than 0.5% of subjects feeling serious adverse events.

“With the Delta variant becoming a dominant strain of COVID-19 in the United States, we believe that the Phase 3 efficacy results reported by Bharat Biotech demonstrate that Covaxin has the potential to become an important option to expand protection against this emerging variant,” said Bruce Forrest, M.D., acting chief medical officer and a member of the vaccine scientific advisory board of Ocugen.

“Combining these data with the only Delta-variant results from a controlled phase 3 clinical trial, evidence continues to support a favorable benefit-risk profile for Covaxin.”

Ocugen has already said it plans to gun for a full approval in the U.S., not an EUA, although whether it can gain approval—alongside what levels of uptake there would be—remains to be seen.

Shares in the biotech were up 14% premarket.