Vaccines, Blood, & Biologics Assessments

This page and the vaccines, blood, and biologics assessments search provide access to Sentinel assessments that have been conducted by the U.S. Food and Drug Administration's (FDA) Center for Biologic Evaluation and Research (CBER).

CBER regulates biologic products. This ensures their safety and efficacy. These products include:

  • blood and blood products
  • vaccines
  • cellular, tissue, and gene therapies

Postlicensure Rapid Immunization Safety Monitoring (PRISM)

PRISM is a subcomponent of the Sentinel System focusing on vaccine safety surveillance. PRISM is for refinement and evaluation of potential safety signals. These potential safety signals include those identified during premarket and postmarket reviews.

Blood Safety Continuous Active Surveillance Network (BloodSCAN)

BloodSCAN is a subcomponent of the Sentinel System. It focuses on blood and blood product safety surveillance. BloodSCAN assesses the safety of different blood products. This is for both the premarket and postmarket settings.

The Sentinel System enables CBER to proactively assess biologics safety under real-world conditions. This reflects patient care in the United States. This capability enhances safety monitoring. It also allows CBER to systematically evaluate safety signals identified during premarket trials. CBER also evaluates safety signals that emerge after products reach the market. 

Sentinel assessments use automated surveillance tools. These same tools support FDA’s Active Risk Identification & Analysis System. This approach improves the efficiency of FDA monitoring. It also ensures patient privacy through the use of the Sentinel Distributed Database. 

CBER uses results to evaluate safety signals. Sentinel assessments complement existing surveillance systems. Existing surveillance systems include the Vaccine Adverse Event Reporting System (VAERS). CBER reviews the results from different surveillance sources. CBER considers the strengths and limitations of each data source. In doing this, they can make the most informed regulatory decisions possible.

CBER Biologics Effectiveness & Safety (BEST) System

BEST is part of the Sentinel Initiative and it promotes CBER's Office of Biostatistics and Epidemiology's (OBE) mission to assure the safety and effectiveness of biologic products including vaccines, blood and blood products, tissues, and advanced therapeutics.

The Biologics Effectiveness and Safety (BEST) System was launched in October 2017 to expand and enhance CBER access to new and better data sources, methods, tools, expertise, and infrastructure to conduct surveillance and epidemiologic studies.

CBER Biologics Effectiveness & Safety (BEST) System

  • Exploratory Analyses
    • Characterize the rates of health outcomes, examine medical product use, and explore the feasibility of more detailed evaluations. 
  • Safety Analyses
    • Build on exploratory work and formally evaluate medical product-outcome associations using more advanced study designs and statistical methods to control for confounding.

Search Vaccines, Blood, and Biologics Assessments

Title Medical Product Outcomes Date
Transfusion-Related Acute Lung Injury after Red Blood Cell, Plasma, and Platelet Administration 2013-2015
Exploratory Analyses
blood transfusion
transfusion-related acute lung injury (TRALI)
09/09/2019
Rapid Surveillance Capability: 2017-18 Seasonal Influenza Vaccines Surveillance
Safety Analyses
05/22/2019
Influenza Vaccines and Birth Outcomes
Safety Analyses
influenza vaccine
cleft lip with cleft palate
cleft lip without cleft palate
cleft palate without cleft lip
02/06/2019
Sequential Analysis of Gardasil 9 Safety
Safety Analyses
9-valent human papillomavirus (HPV9) vaccine
acute disseminated encephalomyelitis (ADEM)
acute pericarditis
complex regional pain syndrome (CRPS)
uveitis
11/28/2018
13-Valent Pneumococcal Conjugate Vaccination (PCV13) and Kawasaki Disease
Safety Analyses
Prevnar 13, 13-valent pneumococcal vaccine (PCV13)
Kawasaki disease
10/24/2018
Influenza Vaccines and Pregnancy Outcomes (PRISM)
Safety Analyses
influenza vaccine
spontaneous abortion (SAB)
01/26/2018
Postlicensure Medical Product Safety Data-Mining: Power Calculations for Bernoulli Data
Exploratory Analyses
12/22/2017
Influenza Vaccines and Febrile Seizures in the 2013-2014 and 2014-2015 Influenza Seasons
Safety Analyses
influenza vaccine, Prevnar 13
febrile seizure
11/10/2017
Counts and Prevalence of 50 Venous Thromboembolism (VTE) Diagnosis Codes
Exploratory Analyses
venous thromboembolism (VTE)
10/09/2017
Pertussis Cases in Infants
Exploratory Analyses
pertussis
07/27/2017
Tdap Vaccination During Pregnancy
Exploratory Analyses
tetanus, diphtheria, pertussis (Tdap) vaccine
pertussis
07/27/2017
Thromboembolic Events After Immunoglobulin Administration
Safety Analyses
intravenous immunoglobulin (IVIg)
acute myocardial infarction (AMI)
ischemic stroke
thromboembolic events (TEE)
venous thromboembolism (VTE)
07/13/2017
Blood Transfusions
Exploratory Analyses
blood transfusion
10/26/2016
Length of Enrollment Among Adolescents after HPV Vaccination
Exploratory Analyses
9-valent human papillomavirus (HPV9) vaccine, human papillomavirus (HPV) vaccine, quadrivalent human papillomavirus vaccination (HPV4)
07/06/2016
Evaluation of HPV9 (Gardasil9) Vaccine Safety Surveillance Using the TreeScan Data Mining Method Surveillance Protocol
Safety Analyses
9-valent human papillomavirus (HPV9) vaccine
06/30/2016
Influenza Vaccines and Febrile Seizures (PRISM)
Safety Analyses
influenza vaccine
febrile seizure
09/18/2015
Gardasil Vaccination and Venous Thromboembolism (PRISM)
Safety Analyses
Gardasil
venous thromboembolism (VTE)
04/21/2015
Accessing the Freshest Feasible Data for Conducting Active Influenza Vaccine Safety Surveillance (PRISM)
Safety Analyses
influenza vaccine
anaphylaxis
febrile seizure
04/06/2015
IVIg Exposure and Renal Failure
Exploratory Analyses
intravenous immunoglobulin (IVIg)
acute kidney failure
acute renal failure
03/07/2015
Influenza Vaccinations and Diagnosis of Seizures
Exploratory Analyses
live attenuated influenza vaccine (LAIV), trivalent inactivated influenza vaccine (TIV)
seizure
03/02/2015
Immunoglobulin and Hemolysis 1
Exploratory Analyses
immunoglobulin (Ig), flebogamma, Gammagard, Gammaplex, Gamunex, Gamunex-C, Gammaked, Hizentra, Octagam, Privigen, vivaglobin
hemolysis
06/10/2014
Immunoglobulin and Hemolysis 3
Exploratory Analyses
immunoglobulin (Ig)
hemolysis
06/10/2014
Immunoglobulin and Hemolysis 2
Exploratory Analyses
immunoglobulin (Ig)
hemolysis
06/10/2014
Intravenous Immunoglobulin (IVIG) Procedures
Exploratory Analyses
intravenous immunoglobulin (IVIg)
06/10/2014
Pneumococcal Conjugate Vaccines and Kawasaki Disease
Exploratory Analyses
7-valent pneumococcal conjugate vaccine (PCV7), generic pneumococcal conjugate vaccine (PCV), 13-valent pneumococcal vaccine (PCV13)
Kawasaki disease
05/29/2014
Intussusception Risk After Rotavirus Vaccination in U.S. Infants (PRISM)
Safety Analyses
rotavirus vaccine, RotaTeq, Rotarix
intussusception
02/03/2014
Occurrence of Selected Biological Generic Drug Products
Exploratory Analyses
epoetin alfa, darbepoetin alfa in albumin solution, darbepoetin alfa in polysorbate, interferon beta-1A, interferon beta-1A/​albumin, interferon beta-1B, pegfilgrastim, somatropin, rituximab, infliximab, adalimumab, trastuzumab, filgrastim
10/10/2013
Occurrence of Selected Biological Product HCPCS Codes
Exploratory Analyses
adalimumab, epoetin alfa, filgrastim, infliximab, interferon beta-1A, interferon beta-1B, somatropin, rituximab, trastuzumab, pegfilgrastim, darbepoetin
10/10/2013
Occurrence of Selected Vaccinations 1
Exploratory Analyses
diphtheria, tetanus, acellular pertussis (DTaP) vaccine, diphtheria, tetanus, acellular pertussis (DTaP)-hepatitis B (Hep B)-inactivated polio vaccine (IPV), diphtheria, tetanus, acellular pertussis (DTaP)-haemophilus influenzae type B (HIB)-inactivated polio vaccine (IPV), diphtheria, tetanus, acellular pertussis (DTaP)-inactivated polio vaccine (IPV), hemophilus influenza B (Hib) vaccine
07/19/2012
Scroll to Top