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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
8.2.2. Electronic Diary ..........................................................................................59
8.2.2.1. Grading Scales ...........................................................................60
8.2.2.2. Local Reactions .........................................................................60
8.2.2.3. Systemic Events ........................................................................61
8.2.2.4. Fever ..........................................................................................62
8.2.2.5. Antipyretic Medication .............................................................62
8.2.3. Phase 1 Stopping Rules ..............................................................................62
8.2.4. Surveillance of Events That Could Represent Enhanced COVID-19
and Phase 2/3 Stopping Rule ...........................................................................64
8.2.5. Randomization and Vaccination After a Stopping Rule Is Met .................64
8.2.6. Pregnancy Testing ......................................................................................65
8.3. Adverse Events and Serious Adverse Events ..........................................................65
8.3.1. Time Period and Frequency for Collecting AE and SAE Information .......65
8.3.1.1. Reporting SAEs to Pfizer Safety ...............................................66
8.3.1.2. Recording Nonserious AEs and SAEs on the CRF ...................66
8.3.2. Method of Detecting AEs and SAEs ..........................................................66
8.3.3. Follow-up of AEs and SAEs .......................................................................66
8.3.4. Regulatory Reporting Requirements for SAEs ...........................................67
8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational
Exposure ..........................................................................................................67
8.3.5.1. Exposure During Pregnancy ......................................................67
8.3.5.2. Exposure During Breastfeeding ................................................69
8.3.5.3. Occupational Exposure .............................................................69
8.3.6. Cardiovascular and Death Events ...............................................................70
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not
Qualifying as AEs or SAEs..............................................................................70
8.3.8. Adverse Events of Special Interest .............................................................70
8.3.8.1. Lack of Efficacy ........................................................................70
8.3.9. Medical Device Deficiencies ......................................................................70
8.3.10. Medication Errors .....................................................................................70
8.4. Treatment of Overdose ............................................................................................71
8.5. Pharmacokinetics ....................................................................................................72
8.6. Pharmacodynamics ..................................................................................................72
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