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A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system

Award Number: R01AI168209
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/17/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system - PROJECT SUMMARY/ABSTRACT Despite the success of the unprecedented COVID-19 vaccine rollout in the U.S., vaccine hesitancy is evident, partly due to safety concerns about severe adverse events (SAEs) surrounding the novel technology of mRNA COVID-19 vaccines and reports of blood clots following receipt of the Janssen COVID-19 vaccine. While rigorous safety monitoring may help support COVID-19 vaccination, it is methodologically challenging to thoroughly evaluate the safety of the two-dose mRNA COVID-19 vaccines and the one-dose Janssen COVID- 19 vaccine. Existing approaches can produce false positive and false negative signals when 1) risk windows after vaccination are incorrectly specified, 2) a constant risk of SAEs during the risk window is wrongly assumed, 3) factors that may influence receipt of the second dose of mRNA COVID-19 vaccines are not accounted for, and 4) the nature of the risk of SAEs during potential overlapping risk windows of the first and second doses of mRNA COVID-19 vaccines is not assessed. 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 novel statistical models to properly measure the risk of new COVID-19 vaccines by allowing the risk level to vary during unknown risk windows and using a data-driven approach to define these risk windows. We will also create a new metric for measuring the risk of SAEs considering both the risk level and the length of the risk window, address the potential overlap of risk windows of two doses, and employ a propensity score model approach to account for factors that may influence receipt of the second dose of mRNA COVID-19 vaccines. We will establish these novel approaches to evaluate COVID-19 vaccine safety and will apply them to existing data from members of Kaiser Permanente Southern California, a large, racially, and socio-economically diverse population. Through this research, we will detect SAEs of concern, better inform the public and policymakers about the safety of COVID-19 vaccines, and generate vaccine safety information that may be helpful for clinicians to deliver appropriate care to those at risk.


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: 2025 ( Subtotal = $698,072 )
2025	2025	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	4	5/15/2025	NON-COMPETING CONTINUATION	$698,072
														Subtotal = $698,072

Issue Date FY: 2024 ( Subtotal = $797,195 )
2024	2024	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	3	4/18/2024	NON-COMPETING CONTINUATION	$797,195
														Subtotal = $797,195

Issue Date FY: 2023 ( Subtotal = $664,451 )
2023	2023	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	2	4/19/2023	NON-COMPETING CONTINUATION	$664,451
														Subtotal = $664,451

Issue Date FY: 2022 ( Subtotal = $531,557 )
2022	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Allergy and Infectious Diseases Research	000	1	5/17/2022	NEW	$531,557
														Subtotal = $531,557

Grand Total All Awards = $2,691,275

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A risk-varying and perturbed self-controlled case series design for assessing the safety of COVID-19 vaccines in a large health care system

Award Number: R01AI168209

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/17/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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