Pennsylvania-based Ocugen selected to market India’s Covaxin in US

Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen

Dr. Shankar Musunuri, Chairman, CEO and Co-Founder of Ocugen, speaks to The American Bazaar.

The worldwide ascent of nationalism over the past decade has touched nearly every aspect of major countries’ domestic and foreign policy agendas, and the Covid-19 pandemic is no exception. The early days of the ongoing public health crisis were defined by geopolitical finger-pointing and recrimination, and today, the global race to introduce and administer effective vaccines has been marred by a similarly antagonistic tone.

India, however, is taking a different and welcome approach. Long known as a preeminent force in vaccine development (70% of the world’s vaccines are developed in India), the rising superpower is engaging in what might be called vaccine diplomacy, supplying doses to combat deadly viruses to a host of countries, including Canada and Brazil.

Now, through a partnership between leading vaccine developer Bharat Biotech and Pennsylvania-based biopharmaceutical company Ocugen, India is seeking to extend that diplomacy to the United States’ effort to immunize its population against Covid-19.  The collaboration aims to introduce Bharat’s Covaxin vaccine (which, it bears noting, was just administered to Indian Prime Minister Narendra Modi) to the U.S. market in the coming months.

In this exclusive interview, we talk with Ocugen Chairman, CEO and Co-Founder Dr. Shankar Musunuri about his firm’s partnership with Bharat Biotech, what distinguishes Covaxin from other coronavirus vaccines on the market, the path to regulatory approval in the U.S., and Ocugen’s ambition not only to be a leader in the fight to end the pandemic, but a substantial job creator in the American Mid-Atlantic and beyond.

Can you give us a quick summary of the current efforts by you and your team at Ocugen to bring a new COVID-19 vaccine to the US?

Dr. Shankar Musunuri: Ocugen and Bharat Biotech, a global leader in vaccine innovation and manufacturing, entered into a definitive agreement to co-develop, supply and commercialize Bharat’s Covaxin, an advanced stage whole viron inactivated COVID-19 vaccine candidate, for the United States.

Under the terms of this agreement, Ocugen will be responsible for clinical development,  regulatory approval, manufacturing, and commercialization in the U.S., with Bharat ready to supply tens of millions of initial doses to be used in the United States upon Ocugen‘s receipt of Emergency Use Authorization (EUA). Beyond that, the two companies will undertake the technology transfer for manufacturing in the United States in order to have a much larger supply of Covaxin doses for the U.S.

Ocugen has moved forward by establishing a highly credible vaccine scientific advisory board and built a team of vaccine industry experts. The company has initiated discussions with the FDA and BARDA to develop the regulatory path for the EUA and eventual full approval in the United States for Covaxin. We’re also in active discussions with manufacturers in the U.S. to produce a significant number of doses to support the U.S. immunization program.

Tell us more about your partner Bharat Biotech.

Bharat has established an excellent track record of innovation with more than 140 global patents, a product portfolio of more than 16 vaccines, registrations in more than 116 countries and WHO pre-qualifications.

Located in what people call “Genome Valley” in Hyderabad, India, Bharat has built world-class research and development and manufacturing facilities for vaccine supply and distribution. They have delivered more than 6 billion doses of vaccines worldwide, including vaccines for influenza H1N1, rotavirus, rabies, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

Tell us more about Covaxin specifically.

Covaxin was developed in partnership between the government of India and Bharat Biotech. Based on favorable Phase 1 and Phase 2 data, it received EUA by the Indian authorities and is currently part of the largest vaccine distribution program in the world.

Unlike two vaccines currently authorized for use in the United States, both of which rely on the new technology of messenger RNA, and also distinct from the other vaccines in the pipeline for potential authorization in the United States at some point later, which are all based on only spike antigen, Covaxin is a whole virion inactivated vaccine based on multi-antigens (including spike and nucleocapsid) – the same technology which has been successful in fighting Polio around the world.

We believe Covaxin will prove safe and effective in children as well as adults in the United States and has a number of important advantages compared to the other present or potential vaccines, making it crucial for the United States to include Covaxin as one of the tools in the fight against the pandemic.

Just a few more of these key advantages – Covaxin is easy to stockpile, store and distribute. It can remain effective for three months at room temperature and can potentially maintain its effectiveness for two years in a normal refrigerator. This will solve enormous problems in distribution, particularly to rural areas.

Also, Covaxin elicits a broad-spectrum immune response –  98.3% seroconversion. Stimulating both humoral and cellular responses against multiple viral proteins, Covaxin has the potential to be a more powerful weapon than the ones we are currently aiming at the pandemic and particularly more likely to remain effective as the virus continues to mutate.

It is very likely that the RNA-based vaccines will have to be remade, essentially software updates added, to keep them effective against the changing viral threat. Covaxin is potentially an insurance policy for the United States against the escape of the virus from these other vaccine technologies.

Where is Covaxinin currently in terms of phase 3 testing?

Enrollment for the phase 3 study in India was completed some time ago, with a total of 25,800 subjects. There have been no reported vaccine-related serious adverse events, and even minor events occur at a much lower rate than some of the other vaccines (adverse events which millions in the United States have by now already experienced).

We expect efficacy data early in March and will proceed full speed ahead at that point towards FDA consideration of EUA for Covaxin in this country.

Once you do you have EUA from the FDA, what happens next?

We will be able to bring an initial supply of tens of millions of doses of Covaxin from India to the United States and get them to work saving American lives. We will also move on the technology transfer process so that larger production can begin in the United States. At this point, we are aiming for 100 million doses this year. We plan to create new jobs in Pennsylvania at Ocugen and various vendors, and additional jobs across the country supporting development, manufacturing, and distribution.

Most importantly of course, the United States will now have access to an additional vaccine that is differentiated and presents many important advantages to help fight the pandemic.

Tell us a little more about yourself, Dr. Musunuri.

Well, I’m a biotech veteran with more than 25 years of results-driven experience in advancing and commercializing a diverse portfolio of products. Before co-founding Ocugen in 2013, I held leadership roles at both big Pharma and startups. Most recently, I founded Nuron Biotech which grew to a commercial company in less than three years.

I spent 15 years at Pfizer, playing major role, as Global Operations Team Leader for the most successful product launch in vaccine history, Prevnar13.

I received my PhD in pharmaceutical sciences from the University of Connecticut and an MBA from Duke University’s Fuqua School of Business.



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