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VRBPAC Briefing Document. Pfizer-BioNTech Covid-19 vaccine (bnt162, pf-07302048) Vaccines and Related Biological Products Advisory Committee. Briefing document. Meeting date: 10 December 2020
U.S. Food and Drug Administration (U.S. Food and Drug Administration)
14 de diciembre 2020
página(s) 1

Del documento de la FDA, los planes de farmacovigilancia y promoción de la seguridad:

Pharmacovigilance

As per usual pharmacovigilance practice, Pfizer will collect and analyze all AEs reported to Pfizer by individuals, such as vaccinated persons and health care providers. To strengthen this data collection, Pfizer has implemented a new web-based tool for capture of AEs. All such reports are subsequently shared by Pfizer with CDC’s Vaccine Adverse Event Reporting System (VAERS) as per regulations. The analyses conducted by Pfizer aim to identify patterns of adverse events in time or persons suggesting potential association with vaccine (ie, signal detection). For identified signals, next steps for further evaluation may include careful case review, characterization of the context in which individual events occur, review of clinical data, review of literature, or conduct a study designed to make formal statistical comparisons within a defined sampling frame.

Pharmacoepidemiology

Multiple long-term pharmacoepidemiology safety studies will be conducted. Three studies will identify cohorts of persons in the US receiving vaccine and estimate the incidence rate of adverse events of special interest over a 30-month period following vaccine availability under the EUA. These studies are designed to enable comparison with unvaccinated rates. Two secondary data analysis studies will include all patients documented as receiving vaccine within Department of Defense and Veteran’s Healthcare Administration, which cover 10 million and 18 million lives, respectively. A third primary data collection study aims to enroll 20,000 health care workers vaccinated with Pfizer-BioNTech COVID-19 Vaccine. These large studies conducted over a long period of time will allow for the study of rare outcomes in diverse populations including subgroups not yet studied in the clinical trial such as pregnant, immunocompromised and very elderly (>85 years of age) persons.

Four additional pharmacoepidemiology safety studies (two in the US, two in the EU), are planned for implementation post-approval by respective regulatory agencies. Taken together these planned studies employ a variety of data sources and analytic methods that are intended to complement FDA/CDC active surveillance safety monitoring initiatives.

Proactive Risk Minimization

Pfizer is also taking multiple enhanced measures to proactively mitigate risks in addition to routine labeling activities including: EUA Fact Sheets for both vaccination providers and recipients, development of multiple educational materials for providers emphasizing key messages about appropriate handling, storage, and preparation of the vaccine to ensure the safe handling and administration of the vaccine and the assurance of complete vaccination regimen. Multiple methods will be utilized to instruct providers and vaccine recipients to report any adverse events. In addition, Pfizer will employ near real-time monitoring, and will communicate as necessary with vaccination sites during cold-chain distribution to ensure quality of the product.

Collaboration with Vaccine Safety Stakeholders

Finally, we have planned these enhanced activities with input from and coordination with external vaccine policy experts including CDC. To ensure transparency, our results will be exchanged with a planned vaccine safety subcommittee that will enable communication between government agencies and manufacturers and the public. Additionally, through this effort, we will learn of emerging safety signals that we will then follow up on in our studies.