Trial Procedures for BNT162b1/2

- Safety and immunogenicity of varying dose levels of BNT162b1 and Bnt162b2. The process was followed by testing the vaccine's safety through the proportion of participants exhibiting adverse events, 
- Immunogenicity assessment through a serum neutralization assay before the 7 and 21-day mark after Dose 1, and 21 days and 35 days after dose 2. 


University of California, Santa Cruz

Pfizer and BionTech are producing two vaccine candidates being studied in adults ranging from 18-55 and 65-85 in a placebo-controlled, observer-blinded dose-escalation study with 2 doses over 21-day intervals.
- BNT162b1: encodes a secreted trimerized SARS-CoV-2 receptor-binding domain
- BNT162b2: encodes perfusion stabilized membrane-anchored SARS-CoV-2 spike

The process is to select a single vaccine candidate and dose level for use.

BNT162b1/BNT162b2 from Pfrizer and BionTech

Walsh, E. E., Frenck, R., Falsey, A. R., Kitchin, N., Absalon, J., Gurtman, A., . . . Gruber, W. C. (2020). RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study. doi:10.1101/2020.08.17.20176651

RNA-Based COVID-19 Vaccine BNT162b2 Selected for a Pivotal Efficacy Study 

Methods for testing BNT162b2

Discussion for BNT162b2

• Disposition and Demographics

• Safety- Reactogenicity 

• Safety- Adverse Events and Shifts in Laboratory Values

• Immunogenicity 

BNT162b1/BNT162b2 Results

• Advance B2 at 30ug into Phase 2/3 with 18-85YO

• Milder systemic reactogenicity profile of B2, primarily 65-85

• Comparable immune response elicited 

• Lower reactogenicity (B2) may be due to the smaller size of the RNA constructs

• Note that immunogenicity decreased with age, yet still exceeded the base-line (GMT) of the convalescent serum panel

• Higer reactogenicity (B1) may be associated with an innate immune shut down of the host 

• B2 (full length spike) present greater diversity. 

• Limitations include: immunogenicity or safety beyond 7 days post dose-2 not available; uncertain importance of humoral and cellular immunity in protection from COVID-19; degree of protection against COVID also unknown. 

• Plan to address limitation with a bigger sample size, and diverse backgrounds

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