This spring, the U.S. Food and Drug Administration (FDA) dashed Ocugen's (NASDAQ:OCGN) dreams of quickly commercializing its coronavirus vaccine candidate. The regulatory agency recommended Ocugen pursue the lengthy traditional route of an approval request instead of an Emergency Use Authorization (EUA) request. And that's what Ocugen is doing.
But Ocugen recently announced an additional plan. And if the plan is successful, the company could beat market-leader Moderna (NASDAQ:MRNA) in one specific area. Ocugen applied for the authorization of its vaccine candidate Covaxin in kids ages two through 18.
The FDA hasn't yet authorized Moderna's vaccine for that population. So what are the chances Ocugen will beat Moderna in this area?
A partnership with Bharat Biotech
First, a bit of background on Ocugen and Moderna. Earlier this year, Ocugen partnered with India's Bharat Biotech to co-develop and co-commercialize Bharat's Covaxin in the U.S. Bharat was just finishing up a late-stage trial. And the company soon afterward announced positive data. The idea was Ocugen could present these results to the FDA and win authorization.
But as mentioned above, the FDA recommended Ocugen go the longer route. And Ocugen indicated it probably would need to launch its own clinical trial to support an eventual approval.
Late last month, Ocugen filed a request with the FDA to launch such a trial. The company plans to enroll several hundred adults. And the goal is to complete the trial in the first half of next year.
Then, Ocugen surprised everyone earlier this month when it announced it had applied for an EUA for Covaxin in kids.
As for Moderna, the vaccine giant has hit a roadblock in its quest for EUA in teens. The FDA is studying international analyses regarding the risk of heart inflammation post vaccination. The analyses concern certain young people who have received mRNA vaccines.
Moderna's vaccine and that of bigger rival Pfizer both use mRNA. So the FDA told Moderna it would take longer to review the company's request for authorization in teens. The delay may extend into January. Moderna said it would wait to request authorization in kids until the FDA completes the teen review.
This means the FDA could give Ocugen the nod before authorizing Moderna's vaccine candidate for young people. So far, only Pfizer has won authorization to vaccinate children ages five and older, and there currently isn't an authorized vaccine for those ages four and under.
An authorization could be a major deal for Ocugen. It would bring in revenue -- and quickly -- and Ocugen would have one part of the market all to itself and share the other part with only one other player.
What's the likelihood of an FDA authorization?
Let's get back to our question: What's the likelihood the FDA will grant Ocugen an EUA in the kids' market? In my opinion, it's not very likely.
The FDA has been extremely cautious when it comes to authorizing a coronavirus vaccine for children. A perfect example of this is the agency extending its review time on the Moderna submission.
As I mentioned above, it seems the FDA needs more from Ocugen to support approval of Covaxin for adults. I'm referring to the FDA's recommendation to Ocugen to apply for approval versus an EUA.
It seems unlikely the FDA would authorize Covaxin for kids when it apparently needs more data to support its use in adults. I would imagine the FDA would require just as much extra material -- or even more -- to support authorization or approval in kids, especially since Bharat's kids trial included far fewer participants than its adult trial (526 kids versus more than 25,000 adults).
Finally, if the FDA grants Ocugen's request, Covaxin could be available in a matter of weeks for children -- but not for adults. In the cases of all FDA authorized coronavirus vaccines, authorization came first in the adult population.
Considering all of these elements, it doesn't look very likely that Ocugen will cross the pediatric vaccine finish line before vaccine-giant Moderna. And that's just one reason why Ocugen stock still remains a very risky bet.