Θάνατος και γενετική μετάλλαξη ΠΙΘΑΝΕΣ παρενέργειες του ΜΗ ΕΓΚΕΚΡΙΜΕΝΟΥ από την FDA εμβολίου COVID‑19 της Pfizer‑BioNTech

Pfizer-BioNTech COVID-19 Vaccine 

The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. 

The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.

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Adverse Event Reporting

Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of Pfizer-BioNTech Vaccine, the following items are required. 

Use of unapproved Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19 under this EUA is limited to the following (all requirements must be met):

1. Pfizer-BioNTech COVID-19 Vaccine is authorized for use in individuals 16 years of age and older.
2. The vaccination provider must communicate to the individual receiving the Vaccine or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving Pfizer‑BioNTech Vaccine.
3. The vaccination provider must include vaccination information in the state/local jurisdiction's Immunization Information System (IIS) or other designated system.
4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
• vaccine administration errors whether or not associated with an adverse event,
• serious adverse events* (irrespective of attribution to vaccination),
• cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
• cases of COVID-19 that result in hospitalization or death.

Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html.

For further assistance with reporting to VAERS, call 1-800-822-7967. The reports should include the words “Pfizer‑BioNTech COVID‑19 Vaccine EUA” in the description section of the report.

5. The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and children, and cases COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID‑19 Vaccine to recipients.

*Serious adverse events are defined as:

• Death
• A life-threatening adverse event
• Inpatient hospitalization or prolongation of existing hospitalization
• A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
• A congenital anomaly/birth defect
• An important medical event that based on appropriate medical judgement may jeopardize the individual and may require medical or surgical intervention to prevent one of the outcomes listed above.

Other Adverse Event Reporting to VAERS and Pfizer Inc.

Vaccination providers may report to VAERS other adverse events that are not required to be reported using the contact information above.

To the extent feasible, report adverse events to Pfizer Inc. using the contact information below or by providing a copy of the VAERS form to Pfizer Inc.

Website

www.pfizersafetyreporting.com

Fax number

1-866-635-8337

Telephone number

1-800-438-1985