Ocugen encounters another problem by bringing its Covid-19 vaccine in partnership with Bharat Biotech to the United States – Endpoints News

In July, Ocugen and Bharat Biotech unveiled Phase III data suggesting that their Covid-19 vaccine, Covaxin, was 77.8% effective in preventing overall disease in India. They are now looking to launch an immuno bypass study to see if those numbers hold up in the United States – but on Friday the FDA said it wasn’t so fast.

Regulators have put partners’ IND on clinical hold, Ocugen shared on Friday. Ocugen’s stock, $ OCGN, fell 9% on Friday’s news, but rose nearly 7% in pre-market trading on Monday.

“The FDA plans to identify the specific deficiencies that are the basis of the clinical suspension and information on how to remedy those deficiencies,” the Malvern, Pa., Based company said in a statement. “The company expects to receive formal written communication with the additional information from the FDA and plans to work with the FDA to resolve its issues as quickly as possible.”

The news comes just weeks after Ocugen applied for an emergency authorization to use the vaccine in partnership with Bharat Biotech for pediatric use only, based on an immuno-bridge study conducted in India.

Covaxin, an inactivated whole virion vaccine, was developed by Bharat Biotech in collaboration with the Indian Council for Medical Research. The World Health Organization granted it an emergency use list earlier this month, saying the jab is “extremely suitable for low- and middle-income countries due to the easy storage requirements.”

In July, Bharat announced that the vaccine was 77.8% effective against Covid-19, regardless of its severity, and 93.4% against serious illness in a phase III trial with more than 25,000 participants in India. Less than 0.5% of patients experienced serious side effects, the Indian biotech said at the time.

Earlier this year, Ocugen announced plans to file an EUA application in the United States in June. But in June, the company said it decided to file a biologics license application instead, on the recommendation of the FDA. At the end of October, Ocugen filed an IND to conduct a phase III immuno-bypass study in “several hundred” American adults who had never been vaccinated or who had received two doses of an mRNA vaccine for at least six months. previously.

A week later, the company submitted an EUA for use in children aged 2-18 based on another immuno-bridge study conducted in India. According to Ocugen, an immunologic bypass study showed that neutralizing antibody responses in the pediatric group were equivalent to those seen in adults.

“Our research suggests that people are looking for more choices when selecting a vaccine, especially for their children,” said CEO Shankar Musunuri. “The availability of a new type of vaccine will allow people to discuss with their child’s doctor the best approach for them to reduce their child’s risk of contracting COVID-19. “

The clinical suspension may not be a good sign for Ocugen’s pediatric EUA, although we will have to wait and see.