The document summarizes key information about vaccine development phases, efficacy, and safety based on Pfizer and Moderna COVID-19 vaccine trials. It notes that Phase 1 trials with 50-100 people evaluate safety, Phase 2 expands to 100-500 people to determine appropriate dosing, and Phase 3 involves tens of thousands of people to further assess safety and efficacy. For Pfizer's Phase 3 trial, over 43,000 people received either the vaccine or placebo. No severe side effects occurred, with most reporting mild injection site reactions or fatigue. Safety monitoring will continue for two years.

1. Important Concepts – Safety and
Efficacy (Effectiveness of the Vaccine)
Efficacy
Vaccination against
the Disease
Vaccination against
the Infection

2. PHASES OF VACCINE DEVELOPMENT
• SAFETY: Any local or whole body side effects
• EFFICACY: Measured Antibodies that
Neutralized the Virus and T-cells
• When COVID injected into animals observed
strong protection
Phase 1: 50-100 people
Safety – healthy people, dose range
Phase 2 :100-500 people who
reflect the population; Dose known
Phase 3: ~43,448 people

3. Pfizer Vaccine Trial Phase 3
• 43,448 people – 21,720 vaccine/21,728 placebo
• Argentina, Brazil, South Africa, US (77%)
• 50% women
• 10% were AA; 2% multiracial, 28% Hispanic
• 21% ≥ 65 years old
• 42% ≥ 55 years old
• Other diseases – 35% Obese, 8% diabetic

4. How Was This Then Done So Quickly?
$24 Billion Given Upfront+No Regulatory Redtape

6. Don’t Show Me Words – Show me a Picture
– this Picture really is a 1,000 words -
New England Journal of Medicine December 10, 2020

7. Moderna
New England Journal of Medicine December 30, 2020

8. • No
preservatives
• No antibiotics
• No adjuvants
• All the
components
are rapidly
cleared

9. Safety
• Definition: Grade 3 –some interference of daily
activity
• Grade 4 – ER visit or hospitalization
• NO GRADE 4 Effects in 21,720 people
• 83% Injection Site Reactions-mild
• Fatigue 2% - grade 3
• Headache- 2% - grade 3
• Safety monitoring continues for two years
• V-safe website