Ocugen hit as FDA calls for full approval filing for Covaxin COVID-19 vaccine

Shares in Ocugen plunged as much as 40% on Thursday after the company indicated that it will no longer seek emergency-use authorisation (EUA) for the COVID-19 vaccine Covaxin in the US, but instead pursue the longer road to full approval. The company said its decision was taken on the advice of the FDA, which recently issued updated guidance stating it may decline to review EUA requests for COVID-19 vaccines for the remainder of the pandemic.

Ocugen, which gained US rights to Covaxin from Indian drugmaker Bharat Biotech, explained that the FDA recently provided feedback on a master file it had previously submitted, requesting further information and data, as well as recommending that the company pursue full approval. Ocugen said data from an additional clinical trial would likely be required to support an EUA submission to the FDA.

Committed to bringing vaccine to US

"While this will extend our timelines, we are committed to bringing Covaxin to the US," remarked Ocugen CEO Shankar Musunuri, calling Covaxin a "differentiated vaccine" that would give the US "a critical tool to include in our national arsenal given its potential to address SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect the US population in the long term." Prior to obtaining the FDA feedback, Ocugen said late last month that it was "on track" with its EUA filing, having initially planned to seek emergency authorisation in April and sell 100 million doses of the vaccine to the US this year.

Covaxin is an inactivated vaccine made using a vero cell manufacturing platform. It was granted an emergency authorisation in India at the start of this year, amid criticism over what some viewed as a hasty approval backed by insufficient evidence of efficacy. Data released in March from a first interim analysis of a Phase III trial showed it was 81% effective, while a second analysis has put the overall efficacy rate at 78%, with the vaccine offering complete protection against severe COVID-19 disease, including hospitalisations. Ocugen also pointed to laboratory studies indicating that Covaxin-vaccinated sera effectively neutralised the B.1.128.2, B.1.1.7 (alpha) and B.1.617 (delta) variants of SARS-CoV-2 first identified in Brazil, the UK and India, respectively.

Meanwhile, Bruce Forrest, acting chief medical officer at Ocugen, said emerging data has also shown the vaccine to be "generally well tolerated with a good safety profile," with India reporting no potential thromboembolic events following the administration of over 6.7 million doses of Covaxin in that country.

According to Ocugen, Covaxin is currently being administered for emergency use in 13 countries, with EUA applications pending in more than 60 others. The company recently acquired exclusive rights to commercialise Covaxin in Canada, where it is holding talks for expedited authorisation with regulators there.

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