Mulligan, M., Lyke, K., Kitchin, N., Absalon, J., Gurtman, A., Lockhart, S., . . . Jansen, K. (2020, January 01). Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. Retrieved August 05, 2020, from https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1

California Polytechnic State University, San Luis Obispo

Tufts University

In the phase 1 and 2 clinical studies with BNT162b1, healthy participants from 18 to 55 years old will receive either the lipid nanoparticle-delivered vaccine at (10µg, 30µg, and 100µg) or placebo. The nucleoside-modified mRNA sequence codes for the spike glycoprotein that is trimerized. IgG antibody binding and spike protein neutralization was dosage dependent. The mRNA vaccine was relatively safe as it would not integrate into host genome and would be translated to produce spike antigen to trigger immune response. One particular enhancement was to add 1-methyl pseudouridine to increase translation efficiency while triggering innate immune response. 
The receptor binding domain (RBD) of BNT162b1 was further modified by the addition of a phage T4 fibritin-derived trimerization domain to increase its immunogenicity before being encapsulated in lipid nanoparticles administered through intramuscular injection. Around 7 days into vaccination, both the BNT162b1 and placebo recipients experienced mild to moderate levels of fatigue and headache, with more frequencies from the BNT162b1 participants. For the most part, no fatal symptoms seem to occur. Persistent follow up will need to be continued for up to half a year while immunogenicity will need to be taken for up to 2 years. Adults over 65 years old are also beginning to enroll in this clinical trial. 


Pfizer BNT162b1

Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report

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