Malvern bio-pharmaceutical company aims to bring COVID-19 vaccine to U.S.

PHILADELPHIA (WPVI) -- A local bio-pharmaceutical company is hoping to bring another Covid-19 vaccine to the U-S.

The company Ocugen in Malvern typically focuses on gene therapy for eye diseases.

The company has pivoted during the pandemic and is hoping to bring a vaccine from India here to the U.S., but there may be a catch.

"We didn't want to sit on the sidelines, we wanted to be part of the solution," said Shankar Musunuri, chairman, C.E.O and founder of Ocugen.

Ocugen is now working with Bharat Biotech in India, hoping to bring their vaccine, Covaxin, to the U.S. later this year.

It's one of two COVID-19 vaccines authorized for emergency use in India.

"One of them had safety and efficacy. This one had very strong phase one and phase two data," said Musunuri.

That's where things get controversial. Covaxin was authorized before submitting results from phase three clinical trials, as is standard protocol.

Dr. Ashish Jha with Brown University School of Public Health told The Wire he thinks that was a mistake.
"I actually have a lot of concerns about Covaxin, not because I think it's not safe or effective but because I don't know. We don't have phase three trial data," said Dr. Jha.

"It's not traditional times or ordinary times, they are extraordinary and I think people need to remember that," said Musunuri.

The team at Ocugen is waiting to see those phase three results, then they hope to use data from India to submit to the FDA for emergency use authorization here in the U.S.

He says they chose this vaccine because it works differently. Other vaccines target the spike protein. Covaxin targets the whole virus and has the potential to offer better protection against new variants.

It's also easily stored, requiring regular refrigeration.

"That becomes a big plus for storage, distribution, and stockpile," Musunuri said. "What happens in the future if we get breakouts, you need to stockpile. What would be the best vaccine to stockpile? A vaccine that can be stored for many, many months to years."

Data from phase three trials which will show efficacy is expected to come out in March. There are more than 25,000 participants in the phase three trial.

If the vaccine is shown to work, the company hopes to be able to bring 100 million doses to the U.S. this year. This will come down to the FDA.
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