Moderna CEO: COVID-19 vaccine approval for kids under 6 expected in a 'couple months'
Moderna CEO Stéphane Bancel joins Yahoo Finance Live to discuss FDA authorization for the company's COVID-19 vaccine for children under 6, the outlook for an Omicron-specific vaccine, and the path forward for company growth after the pandemic.
Video Transcript
- Right now, we're going to talk more about what's going on with the pandemic and, specifically, where we are in vaccinations for the youngest people who have not had protection up until now. Moderna saying in the last couple of days it is going to be filing an emergency use authorization for children, the youngest children who have not gotten access to the vaccine as of yet. The CEO of Moderna is with us now. That is Stéphane Bancel.
Our Anjalee Khemlani is joining us, as well. Stéphane thank you for being with us, appreciate your time. And as I said, parents of young children have been anxiously awaiting this news. Can you tell-- what can you tell me about the timeline, potential timeline, for the filing and ideally, I guess, for the approval?
STEPHANE BANCEL: Yes, good morning, and thank you for the invitation. So we are talking still a couple months to the availability of a vaccine. This is not a couple of weeks. I just want to be realistic for the parents that are waiting and have been waiting for a long time. You know, we need to file all the data to be FDA. We need to review the data. Most probably they're going to want to have an independent advisory board to review the data and provide feedback.
And so we're talking a couple months, but that should come pretty soon.
- Stéphane, Anjalee here. I wonder does that fall in line with what you're expecting now? The pace that the FDA and other regulatory bodies are taking, does it seem to be a little bit slower and a little bit more deliberate, compared to the first round?
STEPHANE BANCEL: Not necessarily, I mean, if you remember, we announced the Moderna phase three data in the adults. That was in November of 2020 now, and it took a good month to get authorization. And, and, and that's the type of things we should, I think, expect to see. Again, with the young children, you want to make sure that the data is reviewed thoroughly. From what I've seen so far, it looks really good, but we're going to want to go spend some detail and make sure that everything is correct.
- I also wonder on the rollout for that, are we expecting that this might come in before the end of the school year, or does it look like more into summer when you're expecting some response?
STEPHANE BANCEL: Yeah, so we are mid-March, so couple months, it's highly possible it's in the spring. I've heard a lot from parents who are very eager to vaccinate their kids as soon as possible. As you know, there is a new wave in Europe called BA.2 that is starting to pop up, and you've seen the ratio of that virus in the US. So I can see some families wanting before the school year. The idea was, of course, at end of summer to be ready for next time we'll go back in during the fall.
JULIE HYMAN: Stefan, talk to us about the latest thinking on boosters here, and not just a booster as well, but potential shots to address Omicron, variants, et cetera. Where does Moderna stand in all of that process?
STEPHANE BANCEL: Yes, so in terms of the Omicron-specific shot, which we are looking, there's a pretty unique and very innovative way to do it, which will be two mRNA molecule in each vial, one containing the existing vaccine on the market that has been approved and one being an 100% copy of the Omicron virus. And the idea by putting both of them in the vaccine at the same total mass-- it will be half the mass for each component-- is that it will provide us the ability to be ready in the fall.
Because what nobody can tell is in the fall, are we going to see a genetic daughter of Omicron as a new variant or a new one coming from left field? If we remember, you know, Delta was not the genetic daughter of Alpha. Omicron was not the genetic daughter of Delta. And so nobody really knows what's coming next.
And we need to be ready for it. I think with this special approach that Moderna can do that other technology cannot do as fast, we will be ready to provide protections to people who want it as come in the early fall.
- Stéphane is the pandemic over this year? And what does over look like for people?
STEPHANE BANCEL: So, again, I want to speak with a lot of caution and humility because the virus has surprised us many times, and I've never managed a pandemic before. We believe that there is an 80% chance that the world slowly goes back to normal for most people. I want to be very careful and respectful of people that are, for example, immunocompromised. Until the virus fully stabilized and we have already very high efficacy, those people are extremely high risk of being hospitalized or dying.
But for most healthy people, I think except if we have a very strange variant with higher virulence back into the fall or next year or the year after, I think that's the piece we just need to be careful. I mean, the good news now is we have mRNA technology, and Moderna is very committed to adapt the vaccine as needed. And we have manufacturing capacity that we didn't have back then.
If you remember, because this was our first product, when the product was authorized in December 2020, we only had 20 million doses to ship for the entire planet, and they all went to the US government. Where we stand now is we have 2 to 3 billion of capacity per year. So if something were to happen, it will be in a much more normal world, a bit like you see with flu, which is, if you want a vaccine, you can walk to a pharmacy. It's available.
So I think for people who would be able to use testing-- for example, when you go see a relative that is at high risk, you're going to want to test yourself at home. That is available now. You can vaccinate and boost yourself. Treatments are available as well. So I think if people use the tools correctly, we can go back to a more normal life.
JULIE HYMAN: I wanted to ask, Stéphane about as we are going back to a normal life and as the pandemic recedes in urgency, what the funding picture is going to look like. The US federal government, for example, has said its funding is waning for vaccines. Is that going to be an issue, not just for global health reasons, but also for Moderna's sales reasons, as we head further into this year and into next year?
STEPHANE BANCEL: Sure. So indeed, the situation in the US is quite unique. Actually, this morning, we announced an increased number of Advance Purchase Agreements with countries around the world. At our Q4 call, on February 24-- and if I remember correctly, I was with you as well-- the number was $19 billion of signed APAs with upfront payments.
Well, this morning, we are increasing this number to $21 billion of advance purchase agreements that have been signed by countries around the world but the US. That number includes $0 coming from the US. So what is not clear today is, will the US become a private market, which is the case for all of the medicines we have access to, or is still going to be in the fall where the US governments buy directly vaccines and make them available for free?
Clearly, that has not been decided. As you well know, the funding is not available. So what we are doing as a company is to get ready for a private market situation. And if you think about it, in the public setting, when the US government was buying, the price of a vaccine was actually very low. The price that the vaccine was sold to the US government is actually much lower than what it was sold in Europe or in Japan because we insisted when we supplied the vaccine contract back in the fall of 2020 to give a reimbursement to the US government for you remember the grant we got to fund a clinical study.
And so actually in an endemic setting, I believe Moderna's average selling price for a vaccine would be higher than what it has been over the last two years.
ANJALEE KHEMLANI: I want to talk to you about that, Stéphane because I know also you're looking at globally, you know, even with your pipeline and the other vaccines you're working on, you're looking at a global scale, specifically looking at setting up in Africa as well. And that helps with, you know, the production going forward.
So tell us the timeline of that right now. How quickly are you going to be able to, you know, get products out, and how does that impact the future of your pipeline?
STEPHANE BANCEL: Sure. So, now, today we have 2 to 3 billion of annual dose capacity that we can make. We just announced last night, actually, a final agreement with the Australian government to build a new Moderna plant in Australia. That is coming with 10-year supply agreement of respiratory vaccine. We are trying to kind of set up a subscription or service type of model in exchange for building the plant on Australian soil.
And in exchange for that plant being available, if there's a new outbreak or pandemic, God forbid, that they can use the capacity we are reserving of a number of doses for whatever virus they want. And as you say, you know, we announced recently we're building a plant in Africa. It will, of course, take a couple years to build a new plant from scratch, like it will in Australia.
We are also having advanced discussions with Canada to build a plant there. But what is exciting to me is the pipeline. If you think, Anjalee, at our vaccine day in 2020, we had nine vaccines in development, zero commercial, zero Phase III. One was in Phase II.
If you look at where we are today, for vaccine day 2022, we have 31 program in development. That is from nine. We have one commercial product. Obviously, everybody knows it. Four Phase III, when we had none, and nine Phase II. And this happened while our team worked really hard during the pandemic. And think about the cash resources we had.
The last time we disclosed financials, we had more than $17 billion of cash. So we are investing that cash extensively. So think about where the Moderna pipeline is going to be just in two years from now.
JULIE HYMAN: All right, thank you so much, Stéphane It's good to see you. Stéphane Bancel is the CEO of Moderna. Really appreciate your time here this morning.
