Pfizer, Inc. · NYSE:PFE
Pfizer — Pfizer Analyst and Investor Call to Discuss Data from an Ongoing Phase 1/2 Study of mRNA-B (July 2020)
18 slides from Pfizer's conference presentation, Jul 1, 2020
Slide 1: COVID-19 Vaccine Development Program
COVID-19 Vaccine Development Program July 1, 2020 1
Slide 2: Disclaimer
Disclaimer • This presentation includes forward-looking statements about, among other things, Pfizer's efforts to combat COVID-19, Pfizer’s Vaccine product candidates, including, among others, the BNT-162 COVID-19 vaccine program and its potential clinical benefits, planned clinical studies, manufac
Slide 3: Mikael Dolsten, M.D., Ph.D.
Mikael Dolsten, M.D., Ph.D. Chief Scientific Officer and President, Worldwide Research, Development, and Medical 3
Slide 4: Pfizer – BioNTech collaboration on vaccines
Pfizer – BioNTech collaboration on vaccines Pfizer and BioNTech began collaborating in 2018 to develop a vaccine for influenza and have now extended that collaboration to develop a vaccine for COVID-19 BioNTech has one of the industry’s broadest technology toolkits including innovative mRNA technolo
Slide 5: mRNA Vaccines: A novel approach with promising vaccine characteristics
mRNA Vaccines: A novel approach with promising vaccine characteristics mRNA vaccine technology uses the cell’s own machinery to stimulate a potentially protective immune response through T cells and neutralizing antibodies Safety: RNA vaccines are non-infectious and pose no known risk of insertional
Slide 6: BNT162 mRNA vaccine program
BNT162 mRNA vaccine program Receptor Spike Protein Binding Domain (RBD) RNA Variant Target Immunization construct 162a1 RBD subunit uRNA prime/ boost 162b1 RBD subunit modRNA prime/ boost Spike-Antigen P2-mutated full Whole Protein 162b2 modRNA prime/ boost spike protein SARS-COV-2 P2-mutated full s
Slide 7: Kathrin Jansen, Ph.D.
Kathrin Jansen, Ph.D. Senior Vice President & Head of Vaccine R&D 7
Slide 8: Rapid, ongoing vaccine development demonstrates strong clinical & regulatory expertise
Rapid, ongoing vaccine development demonstrates strong clinical & regulatory expertise, necessary for potential Fall 2020 product availability Pivotal Phase 2b / 3 Trial Goal: July 2020 Start Up to 30,000 subjects PFE/BNT Letter of Intent Signed March 17, 2020 Pfizer-BioNTech Potential SARS-CoV-2 Re
Slide 9: BNT162b1 – Modified mRNA Vaccine: U.S. Phase 1/2 Study Design and Preliminary Results
U.S. Phase 1/2 Study Design and Preliminary Results BNT162b1 – Modified mRNA Vaccine 9
Slide 10: Twelve participants per dose level were vaccinated with BNT162b1
Twelve participants per dose level (10 μg and 30 μg), were vaccinated with BNT162b1 on Days 1 and 21 and 12 participants received a 100 μg dose on Day 1; 9 received placebo Between May 4, 2020 and June 19, 2020, 76 subjects were screened, and 45 participants were randomized and vaccinated 76 partici
Slide 11: RBD-binding IgG GMCs higher than human convalescent serum panel
In sera from the 30 µg and 100 µg dose level cohorts, RBD-Binding IgG GMCs were substantially higher than in the human convalescent serum panel RBD-Binding IgG GMCs after 1 or 2 doses 27,872 10 5 16,166 4,813 602 RBD-binding IgG (U/mL) 5,880 1,778 10 4 534 1,536 1,260 10 3 10 2 1.2 0.9 0.9 0.9 0.9 0
Slide 12: Virus neutralizing GMTs after booster vaccinations
Virus neutralizing GMTs after the 10 µg and 30 µg booster vaccinations (Dose 2) were higher than the neutralizing GMT of the human convalescent serum panel SARS CoV2 50% Neutralizing Titers after 1 or 2 doses 94 50% serum neutralizing titer 10 3 267 168 33 29 10 2 13 10 10 10 10 10 10 10 10 1 P 1 7
Slide 13: Local reactions with BNT162b1 in healthy adults (18-55 yrs)
Local reactions with BNT162b1 in healthy adults (18-55 yrs) Reported within 7 days after Vaccinations 1 (10µg, 30µg , 100µg) and 2 (10µg , 30µg) 100% Mild Moderate Severe Grade 4 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 10µg 10µg 30µg 30µg 100µg Placebo 10µg 10µg 30µg 30µg 100µg Placebo 10µg 10µg 30µg
Slide 14: Systemic Events with BNT162b1 after Vaccination 1
Systemic Events with BNT162b1 in healthy adults (18-55 yrs) Reported within 7 days after Vaccination 1 100% Mild Moderate Severe Grade 4 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placebo 100µg Placeb
Slide 15: Systemic Events with BNT162b1 after Vaccination 2
Systemic Events with BNT162b1 in healthy adults (18-55 yrs) Reported within 7 days after Vaccination 2: 10 µg & 30 µg 100% Mild Moderate Severe Grade 4 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Placebo Placebo Placebo Placebo Placebo Placebo Placebo Placebo Placebo 10μg 30μg 10μg 30μg 10μg 30μg 10μg 30
Slide 16: Investing in manufacturing at-risk with cumulative vaccine supply goal of up to 100MM doses
Investing in manufacturing at-risk with cumulative vaccine supply goal of up to 100MM doses in 2020 and potentially more than 1.2B doses in 2021 Kalamazoo, MI (USA) Andover, MA (USA) Puurs, Belgium Mainz Region, Germany Pfizer Site BioNTech Site St. Louis, MO (USA) Idar Oberstein, Germany Leveraging
Slide 17: Key Takeaways SARS-CoV-2 mRNA Vaccine BNT162b1
Key Takeaways SARS-CoV-2 mRNA Vaccine BNT162b1 Early positive data from ongoing phase 1/2 study • Preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated, and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-C
Slide 18: Q&A
Mikael Dolsten – Chief Scientific Officer and President, Pfizer Worldwide Research, Q&A Development, and Medical Kathrin Jansen – Chief Scientific Officer and Senior Vice President, Vaccine R&D 18