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PharmTech.com The Real Message Behind Commercial mRNA Products April eBook 2023 Pharmaceutical Technology ® 9 mRNA TReNds True (Pfizer): So, while we were trying to figure out if we had a vaccine itself, we were essentially scaling for commercial capacity. Scaling our manufacturing capa- bilities, processes, etc., to get to where we thought would be necessary to combat a global pandemic. So, it was a lot of risk taken on by Pfizer when everybody began in this process. We all kind of began at the same time. Nobody knew what was going to happen with the virus itself, how mortality would be, what the transmission would look like. I think we were all trying to assume based on various scenarios where this thing could go. And like I said, before we even knew if we had a vaccine, this was the first time mRNA was really on the main stage in the world. Nobody knew if mRNA would work, either. We were essentially investing a significant amount of R&D resources in addition to manufacturing resources and make sure that, on the chance that we have a good vaccine, we want to be ready to be able to help everyone. PharmTech: That was brave from a business perspec- tive as it was a humanitarian act. What was surprising or oddly effective looking back? True (Pfizer): Well, one of the things that have come out of this pandemic, at least for Pfizer culture, is we have adopted what I would call the light speed mental- ity. What this means is to forget the normal bureaucracy and processes. What is the critical path that it would take to get us from point A to point B, and how can we eliminate barriers along the way, and then just focus on the execution piece of it. So, light speed mentality is something that you see permeate, not just now in R&D, but other processes we're also involved in. When you look at a lot of the investments that were made after the 911 terror attacks, the anthrax attacks, a lot of government funding being put into this space. Most of that funding and prioritization was focused around two areas: innovation, so making sure we had flexible vaccine technologies or faster vaccine technol- ogies. A lot of the new companies out there, the vaccine biotechs, are actually born out of some of the funding and the research and development that went on back then, which is a really great thing to see. If you fund it, it will come. And so, innovation but also reliability. So, people knew for quite a while that if we had a pandemic of the scale similar to what we just experienced, there was not enough infrastructure, there was not enough manufacturing capacity capability in the world to try to be able to address it. So, you saw investment early on and actually expanding manufacturing capacity. Now, what it was for, again, was focused on flu vaccine technologies, which unfortunately did not pan out in this pandemic. So, what I think going forward, you see maybe a shift. Innovation and reliability still being very important. But it shifts to also think about diversification of response, diversification of mechanisms, multiple manufactur- ers, multiple contracts, multiple vaccine technologies, in addition to sustainability. Because now that we're coming off of this, we're trying to figure out, all right, we built all of this up, we built up infrastructure, we built up capabilities, we built up process, relationships. You can't underestimate the importance of the relationships built and how all the global community came together to combat the pandemic. Sustainability is really import- ant going forward because we don't want to start from scratch next time around. PharmTech: Has Pfizer been looking at partnering to take a half step at looking to see what's coming toward us from a threat perspective? True (Pfizer): I can't comment on specific discus- sions that are currently ongoing and the content of those discussion. But what I will say is CDC [Centers for Disease Control and Prevention], FDA, BARDA [Biomedical Advanced Research and Development Au- thority], all of HHS [Health and Human Services], are extremely important partners for us during the COVID pandemic response. And we would expect to be able to further engage with them on what the preparation efforts look like for the next time. I do expect that the global community will continue to have these discus- sions going forward to be better prepared for the next one. And you're right, there are things that they're all interested in better surveillance, more surveillance, preparedness from maybe from a process standpoint, infrastructure standpoint. So, everyone is engaged in these discussions, including Pfizer. PharmTech: Bringing up manufacturing capacity, one of the bottlenecks that surprised people was a nor- mal kind of analytical tool, but there just wasn't enough of them. You needed it for quality control, however there was no way to ask the manufacturer to go from 40 a year to 2000 a year on a turn of a dime. True (Pfizer): Absolutely. What you're essentially talking about is the infrastructure surrounding the ability to be able to scale manufacturing very quickly. So, this includes things like raw materials, which for mRNA technology was nonexistent because there weren't any mRNA vaccines, and now that there are in a big way, in a very short amount of time. It's still "I think we were all trying to assume based on various scenarios where this thing could go. —Jane True, Pfizer