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Incorporation of multilevel ontologies of adverse events and vaccines for vaccine safety surveillance

Award Number: R01AI158543
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Incorporation of multilevel ontologies of adverse events and vaccines for vaccine safety surveillance - Incorporation of multilevel ontologies of adverse events and vaccines for vaccine safety surveillance PROJECT SUMMARY Vaccines face tougher safety standards than most pharmaceutical products because they are given to healthy people, often children. Effective and rigorous analyses of post-vaccination adverse events (AEs) is critical to ensure the safety of vaccines. The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program which contains spontaneous reports from 1990 to present. Statistical approaches have been used on VAERS to extract important signals hidden in this large, complex database and offer a hypothesis-free view of the safety characteristics in the underlying data. However, existing methods may miss detecting serious AEs due to modeling under the false assumption of independence between different types of AEs. In response to the FOA, PA-18-873, this proposal addresses the specific objective: “creation/evaluation of statistical methodologies for analyzing data on vaccine safety, including data available from existing data sources such as passive reporting systems or healthcare databases.” We propose to develop a series of methods for vaccine safety surveillance while incorporating adverse event ontology as well as vaccine ontology. Specifically, we will use the Medical Dictionary for Regulatory Activities (MedDRA) and the vaccine ontology (VO) to form the basis of our models for systematically mining and monitoring safety signals. To the best of our knowledge, this is the first attempt to directly incorporate AE and vaccine ontologies in the signal detection method. Multiple AEs may individually be rare enough to go undetected, but if they are related, they can borrow strength from each other to increase the chance of being flagged. Furthermore, borrowing strength induces shrinkage of related AEs, thereby also reducing headline-grabbing false positives. Additionally, multiple AEs may collectively point to an underlying adverse cause, combined with additional expert knowledge from the vaccine ontology, such as vaccine components, we will be able to understand the root cause of different types of AEs. 1


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $374,998 )
2024	2024	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Allergy and Infectious Diseases Research	000	5	12/13/2023	NON-COMPETING CONTINUATION	$337,498
2024	2024	WILLIAM BEAUMONT HOSPITAL	26901 BEAUMONT BLVD # 6D	SOUTHFIELD	MI	48033	OAKLAND	USA	Allergy and Infectious Diseases Research	001	5	5/20/2024	NON-COMPETING CONTINUATION	$37,500
														Subtotal = $374,998

Issue Date FY: 2023 ( Subtotal = $374,998 )
2023	2023	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Allergy and Infectious Diseases Research	002	4	12/8/2022	NON-COMPETING CONTINUATION	$374,998
2023	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	Allergy and Infectious Diseases Research	003	2	9/28/2023	NON-COMPETING CONTINUATION	-$71,161
2023	2022	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Allergy and Infectious Diseases Research	001	3	11/15/2022	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$203,695
2023	2022	WILLIAM BEAUMONT HOSPITAL	3601 W 13 MILE RD	ROYAL OAK	MI	48073	OAKLAND	USA	Allergy and Infectious Diseases Research	004	3	9/28/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$71,161
2023	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Allergy and Infectious Diseases Research	000	2	11/14/2022	NON-COMPETING CONTINUATION	-$203,695
														Subtotal = $374,998

Issue Date FY: 2022 ( Subtotal = $374,998 )
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Allergy and Infectious Diseases Research	000	2	12/21/2021	NON-COMPETING CONTINUATION	$374,998
														Subtotal = $374,998

Issue Date FY: 2021 ( Subtotal = $374,998 )
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Allergy and Infectious Diseases Research	000	1	1/11/2021	NEW	$374,998
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	Allergy and Infectious Diseases Research	001	1	3/16/2021	NEW	$0
														Subtotal = $374,998

Grand Total All Awards = $1,499,992

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Incorporation of multilevel ontologies of adverse events and vaccines for vaccine safety surveillance

Award Number: R01AI158543

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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