fbpx
Top
Align Jersey Booking & Cancellation Policy | Align Jersey
6448
page-template,page-template-content-page,page-template-content-page-php,page,page-id-6448,mkdf-bmi-calculator-1.0,mkd-core-1.0,tribe-no-js,tribe-bar-is-disabled,wellspring child theme-child-ver-1.0.0,wellspring-ver-1.3,mkdf-smooth-scroll,mkdf-smooth-page-transitions,mkdf-ajax,mkdf-grid-1200,mkdf-blog-installed,mkdf-header-standard,mkdf-fixed-on-scroll,mkdf-default-mobile-header,mkdf-sticky-up-mobile-header,mkdf-dropdown-default,mkdf-search-dropdown,wpb-js-composer js-comp-ver-6.1,vc_responsive

Pfizer Protocol

Further information on individual safety trials

To view our safety protocol email click here

Due to the nature of the granted emergency role out of these vaccinations, the standard rigorous long-term safety trials have been unable to be completed. As such the potential short- and long-term risks from occupational exposure are unknown. We will continue to monitor any new data coming through and look forward to understanding more in this regard following the completion of Phase 2 clinical trials.

You can learn more in regards to Phase 1-4 standard safety procedure for developing vaccines here: https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases

For your information you can find the estimated clinical trial phases below:

Pfizer BioNTech: May 2nd 2023: https://www.clinicaltrials.gov/ct2/show/NCT04368728

AstraZeneca: February 14th 2023: https://clinicaltrials.gov/ct2/show/NCT04516746

Moderna: October 27th 2022:  https://clinicaltrials.gov/ct2/show/NCT04470427

Referenced from Pfizer BioNtech Clinical Protocol November 2020. P65-69

https://blazingpress.com/wp-content/uploads/2021/04/C4591001_Clinical_Protocol_Nov2020_Pfizer_BioNTech.pdf

8.3. Adverse Events and Serious Adverse Events The definitions of an AE and an SAE can be found in Appendix 3. AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, or the participant’s parent(s)/legal guardian). The investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible to pursue and obtain adequate information both to determine the outcome and to assess whether the event meets the criteria for classification as an SAE or caused the participant to discontinue the study intervention (see Section 7.1). Each participant/parent(s)/legal guardian will be questioned about the occurrence of AEs in a nonleading manner. In addition, the investigator may be requested by Pfizer Safety to obtain specific follow-up information in an expedited fashion.

 

8.3.1. Time Period and Frequency for Collecting AE and SAE Information The time period for actively eliciting and collecting AEs and SAEs (“active collection period”) for each participant begins from the time the participant/parent(s)/legal guardian provides informed consent, which is obtained before the participant’s participation in the study (ie, before undergoing any study-related procedure and/or receiving study intervention), through and including Visit 7 for Phase 1 participants, and Visit 3 for Phase 2/3 participants. In addition, any AEs occurring up to 48 hours after each subsequent blood draw must be recorded on the CRF. SAEs will be collected from the time the participant/parent(s)/legal guardian provides informed consent to approximately 6 months after the last dose of study intervention (Visit 8 for Phase 1 participants, and Visit 4 for Phase 2/3 participants). Follow-up by the investigator continues throughout and after the active collection period and until the AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator and Pfizer concurs with that assessment. PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 Page 66 For participants who are screen failures, the active collection period ends when screen failure status is determined. If the participant withdraws from the study and also withdraws consent for the collection of future information, the active collection period ends when consent is withdrawn. If a participant definitively discontinues or temporarily discontinues study intervention because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE reported using the Vaccine SAE Report Form. Investigators are not obligated to actively seek AEs or SAEs after the participant has concluded study participation. However, if the investigator learns of any SAE, including a death, at any time after a participant has completed the study, and he/she considers the event to be reasonably related to the study intervention, the investigator must promptly report the SAE to Pfizer using the Vaccine SAE Report Form.

 

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 Pfizer 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 COVID-19 Vaccines) 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 Pfizer 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 Pfizer Safety on the Vaccine 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 Pfizer Safety using the Vaccine 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 Vaccine 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 Pfizer 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 Pfizer 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.

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 document in the source documents 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 Pfizer Safety within 24 hours of the investigator’s awareness, irrespective of whether an SAE has occurred. The information must be reported using the Vaccine 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 Vaccine SAE Report Form is maintained in the investigator site file.

An exposure during breastfeeding report is not created when a Pfizer 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 Pfizer Safety within 24 hours of the investigator’s awareness, regardless of whether there is an associated SAE. The information must be reported using the Vaccine 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 Vaccine SAE Report Form is maintained in the investigator site file.