Overview
The Pfizer-BioNTech COVID-19 Vaccines Medical Data Site is a collection of scientific, evidence-based, non-promotional content made available by Pfizer Medical Affairs.
The Methodology/About page includes a brief description of the Systematic Literature Review approach and SLR Protocol which determines the publications and data appear on the Site. The Pfizer-BioNTech COVID-19 Vaccines Medical Data Site does not provide a comprehensive list of all data related to the Pfizer-BioNTech COVID-19 Vaccine and does not include information related to other COVID-19 vaccines but is based on the defined literature search. As the material provided is intended to be consistent with the methodology section, there may be information provided that is not found in or inconsistent with the Pfizer-BioNTech COVID-19 Vaccine labeling.
Pfizer-BioNTech COVID-19 Vaccine labeling is available from all pages of the website. The information and publicly available links included in the Site are to be used at the sole discretion of the health care professional. Pfizer neither recommends nor endorses any of the websites or articles listed or the information contained therein.
All registered names or brands referenced in this Site remain the property of their respective owners and are included for identification purposes only. Periodic updates based on searches outlined in the Methodology are planned; each page and study states when it was last updated. Because this Site includes information published within an identified timeframe, there may be currently available information that meets the criteria set forth in the Methodology that has not been included. Publication summaries are intended to factually represent the published information and therefore current scientific understanding of a topic may have evolved beyond what is provided in each individual summary. Conclusions should not be drawn from the presence or absence of information.
Systematic Literature Review approach
Studies are identified for this site using a systematic literature review approach:
Inclusion criteria:
- Peer-reviewed publications
- Identify an ‘earliest start date’ timeframe for each vaccine-related topic (e.g. completion of first clinical trial, first identification of a variant of concern, first identification of adverse events of interest)
- Search MEDLINE/OVID using keywords related to vaccine-related topic, vaccine, and timeframe
- Compare search results with the list of studies on View-Hub (COVID-19 vaccine medical data website from International Vaccine Access Center, Johns Hopkins and WHO) to identify any missed articles
- Evaluate Peer-reviewed publications for inclusion
- Screen abstracts to confirm publication matches the topic (completed by medically trained persons)
- Use Newcastle-Ottawa Scale to assess the quality of real-world evidence studies . Studies with NOS score >6 are included. (completed by medically trained persons)
Exclusion criteria:
- Preprints
- Biological mechanism studies
- Case reports
- Clinical series reports
- Congress abstracts or posters
- Modeling studies
- Non-English publications
- Press releases
Use:
- All studies meeting criteria above are included in the Studies section of the website
- Key Point summaries were developed based on publications that met criteria
Protocol:
Website Purpose
To provide up-to-date clinical trial and Real World Evidence from peer-reviewed publications for the Pfizer-BioNTech COVID-19 Vaccine using interactive data visualization of results and objective key summaries for vaccine-related topics.
Overview
The Pfizer-BioNTech COVID-19 Vaccines Medical Data Site is a collection of scientific, evidence-based, non-promotional content made available by Pfizer Medical Affairs.
The Methodology/About page includes a brief description of the Systematic Literature Review approach and SLR Protocol which determines the publications and data appear on the Site. The Pfizer-BioNTech COVID-19 Vaccines Medical Data Site does not provide a comprehensive list of all data related to the Pfizer-BioNTech COVID-19 Vaccine and does not include information related to other COVID-19 vaccines but is based on the defined literature search. As the material provided is intended to be consistent with the methodology section, there may be information provided that is not found in or inconsistent with the Pfizer-BioNTech COVID-19 Vaccine labeling.
Pfizer-BioNTech COVID-19 Vaccine labeling is available from all pages of the website. The information and publicly available links included in the Site are to be used at the sole discretion of the health care professional. Pfizer neither recommends nor endorses any of the websites or articles listed or the information contained therein.
All registered names or brands referenced in this Site remain the property of their respective owners and are included for identification purposes only. Periodic updates based on searches outlined in the Methodology are planned; each page and study states when it was last updated. Because this Site includes information published within an identified timeframe, there may be currently available information that meets the criteria set forth in the Methodology that has not been included. Publication summaries are intended to factually represent the published information and therefore current scientific understanding of a topic may have evolved beyond what is provided in each individual summary. Conclusions should not be drawn from the presence or absence of information.
Systematic Literature Search and Study Selection
The selection of studies for this website is based on the following approach:
Inclusion criteria:
- Peer-reviewed publications
- Identify an ‘earliest start date’ timeframe for each vaccine-related topic (e.g. completion of first clinical trial, first identification of a variant of concern, first identification of adverse events of interest)
- Compare search results with the list of studies on View-Hub (COVID-19 vaccine medical data website from International Vaccine Access Center, Johns Hopkins and WHO) to identify any missed articles
- Evaluate Peer-reviewed publications for inclusion
- Screen abstracts to confirm publication matches the topic (completed by medically trained persons)
- Use Newcastle-Ottawa Scale to assess the quality of real-world evidence studies . Studies with NOS score >6 are included. (completed by medically trained persons)
Exclusion criteria:
- Preprints
- Biological mechanism studies
- Case reports
- Clinical series reports
- Congress abstracts or posters
- Modeling studies
- Non-English publications
- Press releases
Uses:
- All studies meeting criteria above are included in the Studies section of the website
- Key Point summaries were developed based on publications that met criteria
Protocol:
