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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

2.3.2. Benefit Assessment

Benefits to individual participants may include:

• Receipt of a potentially efficacious COVID-19 vaccine during a global pandemic

• Access to COVID-19 diagnostic testing

• Contributing to research to help others in a time of global pandemic

2.3.3. Overall Benefit/Risk Conclusion

Taking into account the measures taken to minimize risk to participants participating in this
study, the potential risks identified in association with BNT162 RNA-based COVID-19
vaccine are justified by the anticipated benefits that may be afforded to healthy participants.

3. OBJECTIVES, ESTIMANDS, AND ENDPOINTS

3.1. For Phase 1
Objectives Estimands Endpoints
Primary: Primary: Primary:
To describe the safety and tolerability In participants receiving at least 1 dose • Local reactions (pain at the
profiles of prophylactic BNT162 of study intervention, the percentage of injection site, redness, and
vaccines in healthy adults after 1 or 2 participants reporting: swelling)
doses • Local reactions for up to 7 days • Systemic events (fever, fatigue,
following each dose headache, chills, vomiting,
• Systemic events for up to 7 days diarrhea, new or worsened muscle
following each dose pain, and new or worsened joint
• Adverse events (AEs) from pain)
Dose 1 to 1 month after the last • AEs
dose • SAEs
• Serious AEs (SAEs) from Dose 1
to 6 months after the last dose

In addition, the percentage of Hematology and chemistry laboratory
participants with: parameters detailed in Section 10.2
• Abnormal hematology and
chemistry laboratory values 1 and
7 days after Dose 1; and 7 days
after Dose 2
• Grading shifts in hematology and
chemistry laboratory assessments
between baseline and 1 and 7 days
after Dose 1; and before Dose 2
and 7 days after Dose 2

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