Alliance for Pandemic Preparedness

August 14, 2020

Phase 1/2 Study of COVID-19 RNA Vaccine BNT162b1 in Adults



  • Mulligan et al. report safety, tolerability, and immunogenicity findings from an ongoing placebo-controlled observer-blinded dose escalation study among 45 healthy adults randomized to receive an anti-SARS-CoV-2 vaccine that targets the spike glycoprotein receptor-binding domain (two doses 21 days apart). Local reactions and systemic events were generally mild, dose-dependent, and transient. Exceptions included one report of severe pain for a high-dose participant, two reports of grade 3 fever, and one report of sleep disturbance. No serious adverse events were reported. 
  • IgG concentrations and neutralizing titers increased with dose level and after a second dose; however, the difference between medium- and high-dose after the first vaccination was not meaningful. As a result, a second high-dose vaccination was not administered. Neutralizing titers were 1.9 to 4.6 times that of a panel of COVID-19 convalescent human sera.  

Mulligan et al. (Aug 12, 2020). Phase 1/2 Study of COVID-19 RNA Vaccine BNT162b1 in Adults. Nature.