Disposition and demographics of trial participants for the BNT162b1/BNT162b2 COVID-19 vaccine candidates (BioNTech/Fosun Pharma/Pfizer): • Age 18-55 (median: 35-37) and 65-85 (median: 68-69) years, split into younger and older cohorts • B1 and B2 candidates each dosed at 10ug, 20ug, or 30ug on a 2-dose schedule, 21 days apart • Participants predominantly white and non-Hispanic/non-Latinx • Among older participants, more female than male

Keck Graduate Institute

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• Disposition and Demographics

• Safety- Reactogenicity 

• Safety- Adverse Events and Shifts in Laboratory Values

• Immunogenicity 

BNT162b1/BNT162b2 Results

Local reaction: B1 (10-30ug)

• 18-55: mild to moderate pain at the injection site; more frequent post-dose-2 within 7 days

• 65-85: 92% reporting mild to moderate pain post-dose-1, and 75% post-dose-2.


Local reaction: B2 (10-30ug)

• Similar pattern observed

• 65-85: no swelling/redness observed


Systemic events: B1 (10-30ug) 

• 18-55: mild to moderate fever and chills post dose 1; 75% reporting fever post dose 2 of 30ug

• 65-85: overall milder reaction; fatigue and headache post-dose-1 or 2; 33% reporting fever post-dose-2

• Overall dose-dependent; greater post-dose-2


Systemic events: B2 (10-30ug) 

• 18-55: 17% reporting mild to moderate fever; small numbers reporting severe systemic events (fatigue, headache, chills, muscle pain, and joint pain) 

• 65-85: 8% reporting mild to moderate fever; no severe events observed 

• Overall milder than B1; 65-85 reporting systemic events similar to placebo group

Safety-Reactogenicity

18-55 YO

• B1: 50% reporting AE compared to 11.1% placebo group 

• B2: 16.7% reporting AE  

65-85 YO

• B1: 16.7% reporting AE 

• B2: 0% reporting AE


Adverse Events and Shifts in Laboratory Values

18-55YO

• B1 (10-30ug): antigen-binding IgG and neutralizing response boosted by dose 2

• B2 (10-30ug): ^

65-85YO

• B1 (10-30ug): lower responses than young

• B2 (10-30ug): ^

Overall 

• clear dose-dependent response between 10-20

• inconsistent response between 20-30 


Immunogenicity

This classification system categorizes 'BL', 'B1', and 'B2' into two distinct levels: a high level, represented by (↑), and a low level, represented by (↓).

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