FDA Rejects Covaxin EUA for Kids

The U.S. Food and Drug Administration turned down Ocugen’s Emergency Use Authorization (EUA) request for Covaxin in children 2 to 18 years. Covaxin is a COVID-19 vaccine the company is co-developing with India’s Bharat Biotech.

Earlier this week, Ocugen indicated the FDA had lifted a clinical hold on its Investigational New Drug Application for the vaccine. The hold was placed in November 2021. The lift allows Ocugen to run a Phase II/III trial supporting a potential Biologics License Application (BLA) for the vaccine. Ocugen and Bharat Biotech have been partners since 2020 to develop the vaccine, which has been authorized in India for people ages 12 and up.

Covaxin is a highly purified and inactivated product developed with a vero cell manufacturing platform. The World Health Organization lists it as one of its authorized vaccines.

In January, Bharat Biotech posted positive data from a Phase II analysis of Covaxin in people ages 12 to 64 who received a booster dose six months after a second dose. The results showed that people who received a booster significantly increased neutralizing titers. Data also found that more than 75% of people in the study had a detectible neutralizing antibody response six months after their second dose. The booster increased antibody titers at day 28 higher than those evaluated after the two-shot primary series.

“Although protection against severe disease remains high six months following the second dose, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected and consistent with what we are seeing with other vaccines,” said Huma Qamar, M.D., associate vice president, clinical development, Ocugen, in the January announcement. “Based on emerging data, a third dose may be beneficial to maintain the highest levels of protection.”

No reason for the rejection of the EUA was given. On Feb. 25, at Ocugen’s fourth quarter and full year 2021 financial report, Shankar Musunuri, Ph.D., chairman, chief executive officer and co-founder of Ocugen, said, “The fourth quarter capped a transformational year of growth for Ocugen as we saw major progress across our portfolio. The clinical hold for the Covaxin development program was lifted, and we bolstered our pediatric Emergency Use Authorization submission to the U.S. Food and Drug Administration with a safety database of more than 36 million teens vaccinated with Covaxin.”

At the time, the company also indicated it had submitted comprehensive responses to Health Canada over its New

Drug Submission (NDS) for the vaccine after receiving a Notice of Deficiency in Dec. 2021. Their responses are under review.

It’s not clear just how much revenue Covaxin would bring in to Ocugen if it is eventually authorized in the U.S. or Canada, given that both countries have available vaccines and have had them available for well over a year. Company stock has ranged from a low in Dec. 2020 of about $0.29 to a high of $17.54 in Nov. but is currently trading for about $2.58 per share.

Although Ocugen has no marketable products, it has a handful in preclinical development that are close to beginning human clinical trials. In his fourth-quarter statement, Musunuri said, “Our lead modifier gene therapy platform candidate, OCU400, received approval to initiate a Phase I/II clinical trial on target.”

In January, Ocugen also entered into a non-binding deal with Liminal, a Canadian company, for Liminal’s manufacture site in Belleville, Ontario. If that deal goes through, Ocugen could develop its internal manufacturing capabilities. As of Dec. 31, 2021, the company had $95.1 million in cash, cash equivalents and restricted cash.