- Pfizer Inc (NYSE:PFE) announced positive topline results from its European Phase 3 study in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC).
- Researchers looked at three key outcomes, including non-inferiority (NI) of immunoglobulin G (IgG) and geometric mean concentrations four weeks after the third dose.
- Of the 20 serotypes, 19 met that endpoint, Pfizer said.
- In August, Pfizer’s 20-valent pneumococcal conjugate vaccine showed that all 20 serotypes met the statistical non-inferiority criteria in US Phase 3 infant study after four doses.
- The study also looked at the same metric at an earlier point: one month after the second dose. Sixteen of the 20 serotypes met non-inferiority.
- And on the final co-primary outcome, the non-inferiority of the percentage of patients with predefined serotype-specific IgG concentrations one month after dose 2, nine of the 20 serotypes met the NI criteria.
- “Strong functional antibody responses” were seen across all 20 vaccine serotypes, similar to that seen with the first two iterations of Prevenar, Pfizer said. Booster responses also increased after doses 2 and 3.
- Safety findings came in “similar to Prevenar 13,” Pfizer said. “Concomitant use with common pediatric vaccines were supported.”
- Price Action: PFE shares are down 1.52% at $45.33 on the last check Monday.
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