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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001
8.3.6. Cardiovascular and Death Events
Not applicable.
8.3.7. Disease-Related Events and/or Disease-Related Outcomes Not Qualifying as AEs
or SAEs
Potential COVID-19 illnesses and their sequelae that are consistent with the clinical endpoint
definition should not be recorded as AEs. These data will be captured as efficacy assessment
data only on the relevant pages of the CRF, as these are expected endpoints.
Potential COVID-19 illnesses and their sequelae will not be reported according to the
standard process for expedited reporting of SAEs, even though the event may meet the
definition of an SAE. These events will be recorded on the COVID-19 illness pages in the
participant’s CRF within 1 day.
NOTE: However, if either of the following conditions applies, then the event must be
recorded and reported as an SAE (instead of a disease-related event):
The event is, in the investigator’s opinion, of greater intensity, frequency, or duration than
expected for the individual participant.
OR
The investigator considers that there is a reasonable possibility that the event was related to
study intervention.
Potential COVID-19 illness events and their sequelae will be reviewed by a group of internal
blinded case reviewers. Any SAE that is determined by the internal case reviewers NOT to
meet endpoint criteria is reported back to the investigator site of incidence. The investigator
must report the SAE to Pfizer Safety within 24 hours of being made aware that the SAE did
not meet endpoint criteria. The investigator’s SAE awareness date is the date on which the
investigator site of incidence receives the SAE back from the internal case reviewers.
8.3.8. Adverse Events of Special Interest
Not applicable.
8.3.8.1. Lack of Efficacy
Lack of efficacy is reportable to Pfizer Safety only if associated with an SAE.
8.3.9. Medical Device Deficiencies
Not applicable.
8.3.10. Medication Errors
Medication errors may result from the administration or consumption of the study
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
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