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

Benison P. Zerrudo
1–2 minutes

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https://www.nature.com/articles/s41586-020-2639-4

  • 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.
  • Reactogenicity refers to the property of a vaccine of being able to produce common, “expected” adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at injection site.
  • 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.

Keywords: COVID-19, RNA vaccine, coronavirus vaccine, COVID-19 vaccine, what is BNT162b1, pfizer vaccine, biontech vaccine, pfizer coronvirus drug, biontech coronavirus drug

Sources:

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

https://en.wikipedia.org/wiki/Reactogenicity

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The Chromoscience uses AI-assisted tools to support the preparation and editing of science articles. Content is reviewed by the editor for clarity and consistency with the cited research before publication. Readers are encouraged to consult the original scientific publications for complete findings, methods, and limitations.

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