Key Factors Contributing to Uncertainty in Moderna's mRNA Vaccine Review

In a conversation with Pharmaceutical Executive Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC discusses the FDA's review process for Moderna's mRNA flu vaccine and its implications for future mRNA therapies.

A transcript of his conversation with Pharmaceutical Executive can be found below.

Pharmaceutical Executive: What were the key factors that contributed to the uncertainty in Moderna’s mRNA Vaccine review process?

Ron Lanton: First, just to kind of rewind the clock back a little bit, the FDA refused to review an application from Moderna to approve its mRNA-based flu vaccine, not really a surprise to me that much, yet still it is.

When HHS Secretary Kennedy came in, he really made no bones about the skepticism behind mRNA. I actually wrote an article about this last year, we were trying to figure out whether or not the FDA was going to lose some of its leadership authority to the European Medicines Association, the EMA, because of this viewpoint.

After covid, we found that mRNA, like everybody else, they thought that this was going to be the platform that turbocharged cures for other things like oncology and other disease states. So this really wasn't outside the norm when this decision came down.

What was interesting was shortly after that announcement, the White House did have a meeting, and subsequently, after that White House meeting, the decision was reversed, and it was reversed in making it so that the FDA is now granting Moderna, a Type A meeting, which is usually reserved for more urgent life and death matters.

But, I think that this type a meeting allows the FDA to reverse course a little bit and just reset the table and say, Okay, we're going to review the application, kind of like, forget what you saw here before, let's go ahead and take a step back and actually proceed forward with a little bit more of a clear head.

PE: What are the next steps for Moderna in terms of vaccine development and regulatory interactions, and how will this influence timelines for new mRNA therapies?

Lanton: I don't really think it does anything for Moderna necessarily. I think it's all systems go, and I think they're going to go ahead, just like any other flu vaccine review year and just keep going forward, one step in front of the other.

I do think, though, that it provides a little bit more of a chilling effect for other manufacturers that have similar technology if they're going to use mRNA.

Will this happen to them? Is there going to be a public intervention like the White House meeting?We're going to have all this debate about whether it was necessary or not.

So I think it puts some doubt in the other manufacturers, I'm not sure if that's really what HHS wants to do, it remains to be seen. I mean, we kind of read the tea leaves about which direction they really want to go, but is it going to be upheld publicly? That's the real question.