Vernon Bernardino
Now, switching to the regulatory front. When do you expect to get approval for an EMA and how many doses are you planning to deliver?
Greg Glenn
So I’m going to turn that over to John, he’s really heading up the commercial.
John Trizzino
Yes. So – yes, it’s a pivotal question, Vernon and so tremendous amount of progress has been made and continues to be made. I think it’s important for everybody to recognize that we’ve built a global manufacturing infrastructure over the last year that has a robust eight different antigen manufacturing facilities in seven different countries. And of course, the dozen different regulatory authorities that we’re engaged with in order to share our information, rolling submissions, as we’ve reported before, about how we’re sharing that information so that we can keep them as updated as we can in our progress.
I think most everybody at this point is aware of the fact that we’ve now filed with our partner Serum Institute in India, Indonesia and the Philippines. Of course, there’s keen interest in what we’re doing in the high-income countries. And so there’s been a lot of work done, specifically over the past few weeks with pre-submission meetings that given us the chance to kind of engage with the regulatory authorities and get some input from them about the variety of topics that would be in that final CMC package, which is really kind of the gating event at the moment.
And we, at this point have alignment with these regulatory authorities on what will be needed, we’ve made some adjustments and that’s taken a little bit of time to execute. But it’s all been, it’s all been very positive. This is resulted in a converging of what these different submissions look like. And so I think what we’re left with is that today, and then kind of through only a short, next couple of months, you’ll be seeing a variety of these submissions being made and complete submissions for review by these regulatory authorities.
So I think, we’re confident in that position and what’s been going on, I think, we’ve also talked about the asset work that we’ve been doing and some of the challenges we’ve had with some of the assays that are generally speaking kind of very complicated to get completed. We’re happy to report again, like the other regulatory filings that we’ve engaged with the appropriate regulatory authorities have sought their comment and input on analytical methods. And that at this point, we were already to include those in the final submissions and that we have now validated all of these assays. And so we’re confident in what the output’s going to be. And we’ve also began testing the produced vaccine with these assays. So I think it’s a great setup for us to get to this emergency use authorization, accelerated approval, EUL and WHO and so across the board. So happy to report all that and provide that update.
Vernon Bernardino
Now, is there any prioritization of these submissions?
John Trizzino
I think because they’ve all converged, I mean, Greg could comment on that a little bit, because he’s been knee deep in some of the technical parts of those documents, but I think at this point, we’d love from a prioritization standpoint for all of them to happen tomorrow. But it’s only going to be, a few short weeks after that, that that we’ll be able to do that. So not necessarily a prioritization because, those packages will be fairly similar and comparable. Greg, did you want to add to that?
Greg Glenn
Yes, there’s just a lot of overlap on the types of information that needed to be submitted. Everyone has their custom set of questions. And so I think it’s really kind of a cloud marching together with these different regulators. So, we’re trying to – we’re trying to respond to everybody on timeframe. So, I think U.S., MHRA, EMA, India, Indonesia, they’re all getting our attention. And I don’t think there’s really a priority, I couldn’t say there’s really a prioritization as much more responding to all the information requests we get from this.
Vernon Bernardino
I’m definitely making a shameless plug for my home country, the Philippines.
Greg Glenn
Well, they are – they’re just to say, that shameless plug, they are confident. They’re reviewing our package. They really like our vaccine. That’s the – that’s the play there it’s, they’ve got a big unmet need and they know what they’re doing. So they’ve…
Vernon Bernardino
That’s true. They definitely want a protein vaccine for sure. How many doses are covered by your advance purchase agreements?
John Trizzino
So, yes, that’s a good question too. I mean, we’ve done a lot of work there as well, and we’ve at this point have reported, much of this, but to frame it, we’ve got, the 1.1 billion doses that have been committed as part of our CEPI, Gavi, Covax commitments with 350 million of those doses coming from Novavax, anther 750 coming Serum, and which those would – and intentionally. So the way that we tech transferred to Serum was to be able to allow them to ship to low and middle income countries. We have advanced purchase agreements in about 400 million doses with New Zealand, Australia, Canada, UK the most recent one that was announced was up to 200 million doses with the European Commission. We still have the 110 million doses that we’re manufacturing for the U.S. government under the original operation work speed. And then of course, this is just kind of the preliminary, first step that would take us through shipments that would be completed by the first half of next year. And then there’s the conversations we’re already having about additional orders on top of that, what does it mean for booster demand? There are still many, many countries, upper middle income countries Tier 2 high-income countries that are still kind of woefully behind as far as their vaccination rates that they still have to get their first regimens, but then they have to then follow up shortly and get their booster dose as well. So, our assessment based upon all of the research we’ve done, the conversations we’ve been having with all of the global organizations and policy setters that the global demand is continuing to outpace supply. We’re going to probably continue to be in this pandemic period easily into 2023. And we look forward to our global supply of being in minimum of 2 billion doses in all of 2022.
Vernon Bernardino
Now this is a herculean effort in probably every corner of the company. And so a lot has come together as far as being in a position to not only put these agreements together, see the needs out there putting these tech transfers and so on. Can you tell about the manufacturing capacity? That’s one of the things that perhaps had been scrutinized the most in the past year. What progress have you made to get ready with your supply chain and what remains outstanding to reach, let’s say the monthly capacity of 100 million doses by the end of the month and 150 million by the end of December?
John Trizzino
Well, yes, we’re virtually there. I mean, it’s been you’re right. It has been a significant amount of effort put forth to build this infrastructure basically from a dead stop, right. We didn’t have any manufacturing capacity in place when we began this COVID-19 adventure if you will. And have built that, built it up in the combination of contract manufacturing facilities, Fuji in the U.S., Fuji in the UK, Biofabri in Spain, we have an owned facility in the Czech Republic that has the capacity produced 100s of millions of doses. Of course, our partnership with Serum Institute in India work we’re doing it at SK Bio in South Korea a licensure that we have with Takeda in Japan.
And so, that tech transfer takes a significant amount of effort. You go through a scaling up process to make sure that you can manufacture at scale, and then you go through a cadence process whereby you’re improving the cadence on a monthly basis. So that you’re manufacturing increased number of batches over that period of time to maximize the capacity of that facility. But yes, a 100 million doses, as we’ve talked about before the run rate by the end of Q3 and 150 million dose run rate by the end of the year |
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