CLAIM #48295 · Pfizer Inc (PFE) · 2023Q3 earnings call · Oct 31, 2023 · due Apr 30, 2024
“Following these positive immunogenicity data, we plan to initiate a Phase 3 study in the coming months.”
Mikael Dolsten · President, Pfizer R&D
In context
“ccine, which I will review now. In positive Phase 1/2 topline data announced last week, we observed that reformulation of the lead flu candidates resulted in improved immunogenicity against influenza B, allowing us to meet all criteria for advancement to Phase 3. In the trial, our lead candidate formulations induced robust immune responses, with point estimates for Geometric Mean Titer ratios that were consistent with criteria applied to approved vaccines for all matched flu and SARS-CoV-2 strains. Notably, point estimates for Geometric Mean Titer ratios with selected candidate formulations were greater than one relative to the licensed comparator for all matched flu vaccine strains. The safety profiles of evaluated candidates were consistent with Pfizer and BioNTech's COVID-19 vaccine. Following these positive immunogenicity data, we plan to initiate a Phase 3 study in the coming months. Successfully developing a broad seasonal vaccine franchise anchored around a modFlu mRNA vaccine is a key priority, as it may allow us to tap into the nearly 50% annual flu vaccination rate in US adults. We are taking a differentiated approach in pursuit of this goal, leveraging both mRNA and protein subunit technologies. Our development program includes double and triple combination vaccines to potentially help protect against flu, COVID-19, and RSV. Now, turning to PREVNAR, I'll start by reminding you that this is the only PCV business with an FDA indication for pneumonia in adults. Providing protection specifically against pneumococcal pneumonia is critical. It's the most common form of pneumococcal disease in adults, leading to 150,000 US hospitalizations each year. The prevalence”
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SEC filings for PFE ↗ · Claim quote is verbatim from the 2023Q3 earnings call.