This is the pfιzєr study on the CÖVÌD mRNA ναccιnє efficacy . I don't pretend to interpret the information without bias, but section 8.4.3 (below) regarding reporting exposure incidents doesn't sound good at all.. I highlighted my concerns

https://media.tghn.org/medialibrary/2020/11/C4591001_Clinical_Protocol_Nov2020_pfιzєr_BioNTech.pdf
                                     
8.3.4. Regulatory Reporting Requirements for SAEs Prompt notification by the investigator to the sponsor of an SAE is essential so that legal obligations and ethical responsibilities towards the safety of participants and the safety of a study intervention under clinical investigation are met. The sponsor has a legal responsibility to notify both the local regulatory authority and other regulatory agencies about the safety of a study intervention under clinical investigation. The sponsor will comply with country-specific regulatory requirements relating to safety reporting to the regulatory authority, IRBs/ECs, and investigators. Investigator safety reports must be prepared for SUSARs according to local regulatory requirements and sponsor policy and forwarded to investigators as necessary. An investigator who receives SUSARs or other specific safety information (eg, summary or listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the study and will notify the IRB/EC, if appropriate according to local requirements. 8.3.5. Exposure During Pregnancy or Breastfeeding, and Occupational Exposure Exposure to the study intervention under study during pregnancy or breastfeeding and occupational exposure are reportable to pfιzєr Safety within 24 hours of investigator awareness. 8.3.5.1. Exposure During Pregnancy An EDP occurs if: • A female participant is found to be pregnant while receiving or after discontinuing study intervention. • A male participant who is receiving or has discontinued study intervention exposes a female partner prior to or around the time of conception. • A female is found to be pregnant while being exposed or having been exposed to study intervention due to environmental exposure. Below are examples of environmental exposure during pregnancy: • A female family member or healthcare provider reports that she is pregnant after having been exposed to the study intervention by inhalation or skin contact. PF-07302048 (BNT162 RNA-Based CÖVÌD-19 ναccιnєs) Protocol C4591001 Page 68 • A male family member or healthcare provider who has been exposed to the study intervention by inhalation or skin contact then exposes his female partner prior to or around the time of conception. The investigator must report EDP to pfιzєr Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The initial information submitted should include the anticipated date of delivery (see below for information related to termination of pregnancy). • If EDP occurs in a participant or a participant’s partner, the investigator must report this information to pfιzєr Safety on the ναccιnє SAE Report Form and an EDP Supplemental Form, regardless of whether an SAE has occurred. Details of the pregnancy will be collected after the start of study intervention and until 6 months after the last dose of study intervention. • If EDP occurs in the setting of environmental exposure, the investigator must report information to pfιzєr Safety using the ναccιnє SAE Report Form and EDP Supplemental Form. Since the exposure information does not pertain to the participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed ναccιnє SAE Report Form is maintained in the investigator site file. Follow-up is conducted to obtain general information on the pregnancy and its outcome for all EDP reports with an unknown outcome. The investigator will follow the pregnancy until completion (or until pregnancy termination) and notify pfιzєr Safety of the outcome as a follow-up to the initial EDP Supplemental Form. In the case of a live birth, the structural integrity of the neonate can be assessed at the time of birth. In the event of a termination, the reason(s) for termination should be specified and, if clinically possible, the structural integrity of the terminated fetus should be assessed by gross visual inspection (unless preprocedure test findings are conclusive for a congenital anomaly and the findings are reported). Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal demise, neonatal death, or congenital anomaly), the investigator should follow the procedures for reporting SAEs. Additional information about pregnancy outcomes that are reported to pfιzєr Safety as SAEs follows: • Spontaneous abortion including miscarriage and missed abortion; • Neonatal deaths that occur within 1 month of birth should be reported, without regard to causality, as SAEs. In addition, infant deaths after 1 month should be reported as SAEs when the investigator assesses the infant death as related or possibly related to exposure to the study intervention. PF-07302048 (BNT162 RNA-Based CÖVÌD-19 ναccιnєs) Protocol C4591001 Page 69 Additional information regarding the EDP may be requested by the sponsor. Further follow-up of birth outcomes will be handled on a case-by-case basis (eg, follow-up on preterm infants to identify developmental delays). In the case of paternal exposure, the investigator will provide the participant with the Pregnant Partner Release of Information Form to deliver to his partner. The investigator must docuмent in the source docuмents that the participant was given the Pregnant Partner Release of Information Form to provide to his partner. 8.3.5.2. Exposure During Breastfeeding An exposure during breastfeeding occurs if: • A female participant is found to be breastfeeding while receiving or after discontinuing study intervention. • A female is found to be breastfeeding while being exposed or having been exposed to study intervention (ie, environmental exposure). An example of environmental exposure during breastfeeding is a female family member or healthcare provider who reports that she is breastfeeding after having been exposed to the study intervention by inhalation or skin contact. The investigator must report exposure during breastfeeding to pfιzєr Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The information must be reported using the ναccιnє SAE Report Form. When exposure during breastfeeding occurs in the setting of environmental exposure, the exposure information does not pertain to the participant enrolled in the study, so the information is not recorded on a CRF. However, a copy of the completed ναccιnє SAE Report Form is maintained in the investigator site file. An exposure during breastfeeding report is not created when a pfιzєr drug specifically approved for use in breastfeeding women (eg, vitamins) is administered in accord with authorized use. However, if the infant experiences an SAE associated with such a drug, the SAE is reported together with the exposure during breastfeeding. 8.3.5.3. Occupational Exposure An occupational exposure occurs when a person receives unplanned direct contact with the study intervention, which may or may not lead to the occurrence of an AE. Such persons may include healthcare providers, family members, and other roles that are involved in the trial participant’s care. The investigator must report occupational exposure to pfιzєr Safety within 24 hours of the investigator’s awareness, regardless of whether there is an associated SAE. The information must be reported using the ναccιnє SAE Report Form. Since the information does not pertain to a participant enrolled in the study, the information is not recorded on a CRF; however, a copy of the completed ναccιnє SAE Report Form is maintained in the investigator site file. PF-07302048 (BNT162 RNA-Based CÖVÌD-19 ναccιnєs) Protocol C4591001 Page 70 8
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I'm not sure if these are standard reporting mechanisms for any trial "ναccιnє", but since it was in the CÖVÌD 19 study, and since the ναccιnє is still considered an experimental trial and under emergency distribution, I thought it was significant.
To me this shows there is a strong concern by  pfιzєr of the significant possibility of casual transmission from vaxxed to unvaxxed persons