Pfizer Pflash: A Spotlight On Clostridioides difficile (C. diff) Vaccine Development Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Evan Seigerman - BMO Capital Markets - Analyst : Okay. Thank you so much for taking my question. Thanks for this presentation. So as you think about the unmet need in C. diff, I know there's clearly -- it's clearly a big issue for seniors. I guess, how do you envision this product actually -- how do you say this? How do you envision this product being used in the real world? Is it for a specific type of at-risk senior? Is it for a broad population? And secondarily to that, what would the potential uptake curve look like, knowing that -- assuming that the Phase 3 trial for this is successful? Thank you, guys.

Question: Evan Seigerman - BMO Capital Markets - Analyst : Yeah. I guess the follow-up is -- the second part is, who would be the best candidate for this vaccine, assuming the data is successful? Is it a wide variety of patients or is it going to be more focused at those who would be higher risk? And how would that be defined?

Question: Trung Nguyen - UBS - Analyst : Hi, guys. Thanks for the presentation. Just two from me, please. So in the intro, you noted C. diff is caused by toxin A and toxin B, which is what you're targeting with your vaccine. There's actually some strains that produce a third toxin, binary toxin, which is associated with more severe infections. So does your vaccine generate any immunity to that? And if not, I'm wondering how common the third toxin is in some C. diff strains. And then secondly, you noted C. diff is common in elderly patients. I'm curious, in the data that you've seen, if you're seeing any waning of efficacy as you get older. Older people may not be able to mount as much of a strong immune response to vaccines, so anything that would be helpful. Thank you. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 18, 2024 / 3:00PM, PFE.N - Pfizer Pflash: A Spotlight On Clostridioides difficile (C. diff) Vaccine Development

Question: Ethan Brown - JPMorgan Chase & Co - Analyst : Hi, this is Ethan on for Chris. Thanks for taking my questions. Just two for me. The first is, how do you think about the timeline of the potential Phase 3 trial this time around, given the CLOVER trial took around five years to be announced but was affected by COVID? And then on the duration of the C. diff vaccine, any information you have here? It seems like this is a regimen that patients will only need to take once. Is that fair to say? Thank you.

Question: Vamil Divan - Guggenheim Securities LLC - Analyst : Great. Thanks for hosting us, for taking questions. So couple of questions, if I could. So one, you shared your Phase 2 data over the prior vaccine Phase 3 data. And now, you're mentioning you might be able to go to a two-dose regimen. Can you just share a little bit more on what you've seen in terms of immunogenicity data that gives you comfort that this could be potentially a two-dose regimen? And then my other question is maybe a broader question. This may not be fully accurate, but I feel like there's been a number of other companies that have also worked on C. diff vaccines previously that have not been successful. So appreciate reviewing what Pfizer has done, but maybe you can just provide some broader perspective on the broader attempts that have been made here and what have been some of the challenges and why things might turn out differently this time?

Question: Geoff Meacham - Citi - Analyst : Hey, guys. Thanks for hosting this. I really appreciate it. Just have a couple of quick ones. The first one -- I know it's hard to assess, but just given what could be newer regulatory attitudes towards vaccines and development, what's your guys' view of whether you'll need a bigger safety database or, for example, longer follow up versus what you normally would design, thinking just of the Phase 3 trial? And then on C. diff, I think when you look historically, you see outbreaks and at risk populations like the elderly that really drive the infection rates. Yeah. How does Pfizer maybe raise the bar for awareness to justify this being part of a broader vaccine regimen? Thank you very much.

Question: Geoff Meacham - Citi - Analyst : Yeah, I think that's the right -- when you follow the epidemiology, that is concentrated in those settings.

Question: Steve Scala - TD Cowen - Analyst : Well, thank you so much. I have a couple of follow-ups and then a question. So first, relative to uptake, how might uptake of C. difficile vaccine compare to that of a pneumococcal vaccine among older people? So would you expect it to be more robust than a pneumococcal vaccine, less robust, or would it be similar? Second, did you approach regulators with the first-generation data? Pfizer thought it was provocative. But if you did approach regulators, should we assume that they didn't agree? And then lastly, my question, if C. diff is such a significant problem, then to what do you attribute the modest success of the therapeutic DIFICID? Thank you.

Question: Nicole Germino - Truist Securities, Inc. - Analyst : Hi, good morning. Thanks for taking our question. This is Nicole on for Kripa. On the Phase 2 for the next gen vaccine, can you just remind us what the endpoints are and what the bar for success is for the Phase 2 dose that you would potentially use for the Phase 3?

Question: Nicole Germino - Truist Securities, Inc. - Analyst : Sure. Sorry about that. So for the Phase 2, can you remind us what the endpoints are and what the bar is for success for the Phase 2 dose that you would use for the Phase 3 trial?

Question: Nicole Germino - Truist Securities, Inc. - Analyst : Will you also be having the first episode of CDI also as one of the endpoints that you would be looking at, too? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 18, 2024 / 3:00PM, PFE.N - Pfizer Pflash: A Spotlight On Clostridioides difficile (C. diff) Vaccine Development

Question: Nicole Germino - Truist Securities, Inc. - Analyst : Thank you.