12 August 2020
- In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19).
- The causative agent of COVID-19 is the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
- A vaccine is urgently needed due to the rising cases and deaths reported globally.
- This study reports the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults.
- The healthy adults include 18 to 55 years of age.
- The healthy adults were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1.
- BNT162b1 is a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD).
- Local reactions and systemic events were dose-dependent, generally mild to moderate, and temporary.
- A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose.
- RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose.
- Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 illness-recovering human sera at least 14 days after a positive SARS-CoV-2 polymerase chain reaction.
- These results support further evaluation of this mRNA vaccine candidate.
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Mulligan, M.J., Lyke, K.E., Kitchin, N. et al. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature (2020). https://doi.org/10.1038/s41586-020-2639-4. https://www.nature.com/articles/s41586-020-2639-4