Novavax (NVAX -10.14%) hasn't won Emergency Use Authorization (EUA) for its COVID-19 vaccine yet. However, the company might do so relatively soon. It's also exploring the potential for a combination of its COVID-19 vaccine and its promising flu vaccine candidate, NanoFlu.
In this Motley Fool Live video recorded on June 16, Motley Fool contributors Keith Speights and Brian Orelli discuss whether or not the small biotech should be viewed as the leader in developing a COVID-19/flu combo vaccine.
Keith Speights: Now, Novavax (NVAX -10.14%) also had some other news on Monday. The company announced results from the first study of simultaneous administration of its COVID 19 vaccine along with an approved flu vaccine. Now these are two different shots being given but at the same time. How significant are those results in the big scheme of things?
Also, Novavax is planning to test an actual combination of its COVID vaccine with its own flu vaccine, NanoFlu, in the near future. Do you think Novavax might even be the leader ultimately in developing a combo COVID/flu vaccine?
Brian Orelli: This was a subset study from the U.K. A subset of people in the U.K. study also got the flu vaccine at the same time that they got the COVID vaccine and then they measured the COVID efficacy. They saw there was 87.5% versus 89.8% for the entire population in the clinical trial. A little bit lower. It was a fairly small number, so I'm not sure that was really significant.
I agree the combination of a COVID vaccine with the NanoFlu is a much bigger deal because then we're talking about one shot versus two shots. I'm not sure this data really moves that along very much.
If you're super optimistic, maybe you think the immune system can handle two vaccines at the same time, I'm more a wait-and-see neutralist person even though I'm a shareholder here. I think the immune system is fickle, so I don't know that we'll really have real confirmation that NanoFlu works with its COVID vaccine until we actually see the data.
But definitely one shot versus two, I think there's a big deal for patients. You also shouldn't really discount the benefit to doctors. It's one less syringe to have to prepare during the day for each patient. Then it's also one less vaccine to store. That's a big deal in terms of making sure that you have the right supplies at the right time for the patients.
Speights: It's obviously still very early to talk about the possibility of a combo flu/COVID vaccine. But Novavax at least has late-stage candidates on both fronts. They do have their COVID vaccine that as we've just talked about had some really great late-stage results. They had great results for NanoFlu reported last year.
As far as I know, I know that Pfizer (PFE -0.57%) and BioNTech (BNTX -0.55%) are working together on an mRNA flu vaccine, but I don't even think it's in clinical testing yet. Moderna (MRNA -3.19%) has talked about advancing a flu vaccine into clinical studies this year. I don't think Johnson & Johnson (JNJ -0.61%) has flu vaccine plans. At least right now, it seems like Novavax actually is the leader in this combo area. What do you think?
Orelli: Definitely they're the leader, I just don't think we have 100 percent data to show that they can be able to develop that combination. But I think that they are definitely the most advanced in the ability to have a combined coronavirus flu vaccine.
Speights: Yeah. Obviously, we will have to wait and see how did the study results go and everything. But it's always good to be the leader if you're successful, if the study results go well.
Orelli: Yeah. The big question I think is going to be, is the FDA going to require them to show efficacy or are they going to require them to show the antibodies?
I would think that they will probably only require them to show the antibody levels and that because they've already shown individually that the vaccines have efficacy against the actual virus.
I think the FDA will probably only require them to show that the antibody levels when you give it together are comparable to what we saw when we gave it individually. If that's the case then it should be a fairly quick clinical trial to get the results.
Speights: This is a story we'll certainly be watching over the next year or however long it takes.