Tuesday, September 16, 2025 9/16/2025

Maternal COVID-19 Vaccination and Lactation Outcomes

Award Number: R01HD107753
ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2022
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Maternal COVID-19 Vaccination and Lactation Outcomes - PROJECT SUMMARY (From Parent Award, R01HD107753) The efficacy of coronavirus disease (COVID-19) vaccines available in the US is up to 95% against symptomatic COVID-19. However, pregnant and lactating individuals were excluded from initial clinical trials. COVID-19 vaccine trials are now underway in pregnant women in their second or third trimester but are not expected to conclude until 2022 or 2023, and evaluation of lactation outcomes is not planned. COVID-19 vaccines are highly effective, and mounting evidence suggests immunogenic protection for breastfed infants of mothers receiving COVID-19 vaccines. To date, there are no published studies on COVID-19 vaccine safety during pregnancy or lactation for breastfed infants, milk production and excretion, or other lactation-related outcomes. This lack of safety data threatens to undermine vaccination efforts in pregnant and lactating women. Traditional data sources used for post-licensure surveillance have limited relevance for lactation outcomes. Spontaneous reporting systems suffer from reporting bias due to their voluntary nature; their lack of a denominator of vaccinated lactating women precludes risk estimates. The CDC's V-Safe program, smart phone-based monitoring for vaccine side effects, does not capture lactation status. Ongoing health care claims-based surveillance studies also do not routinely capture lactation. Observational studies enrolling COVID-vaccinated lactating women rely primarily on self-reported outcomes and have limited generalizability. To address the need for comprehensive safety data, we propose a novel study of antenatal and postpartum COVID-19 vaccination and lactation-related outcomes in mother-infant pairs, including more than 11,000 breastfeeding dyads. We will use electronic health record data linked with state immunization data across four large health systems to study infant growth, infant heath care utilization, maternal mastitis, and breastfeeding status up to 7 months after delivery following maternal COVID-19 vaccination. Also, we will explore acute infant outcomes and abnormal infant developmental screens following maternal COVID-19 vaccination. We are uniquely positioned to overcome lack of information on lactation status and reporting and volunteer bias using routinely collected information on breastfeeding at well-child visits for a defined population. We will apply rigorous epidemiologic methods, including propensity score adjustment, to address confounding. With a focus on lactation, our study will complement other studies of COVID-19 vaccination in pregnancy and studies collecting milk samples from COVID-19-vaccinated volunteers. It will provide essential and currently unavailable evidence regarding lactation-related outcomes following perinatal COVID-19 vaccination. Findings supporting safety can reduce vaccine hesitancy, whereas results identifying a potential harm will be important for informing patient decision making. Furthermore, the novel approach and methods for studying lactation related outcomes developed through the proposed study can be adapted to efficiently evaluate the safety of drugs and vaccines currently recommended or being investigated for use in pregnant or postpartum women


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 = $0 )
2025	2024	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	004	3	7/29/2025	NON-COMPETING CONTINUATION	$0
2025	2024	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	003	3	7/11/2025	NON-COMPETING CONTINUATION	$0
2025	2024	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	3	3/13/2025	NON-COMPETING CONTINUATION	$0
2025	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Trans-NIH Research Support	001	2	3/20/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Trans-NIH Research Support	005	2	8/15/2025	SUPPLEMENT FOR EXPANSION	$0
2025	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Trans-NIH Research Support	002	2	7/11/2025	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $548,002 )
2024	2024	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	001	3	5/21/2024	NON-COMPETING CONTINUATION	$548,002
2024	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Trans-NIH Research Support	000	2	2/16/2024	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $548,002

Issue Date FY: 2023 ( Subtotal = $853,135 )
2023	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Trans-NIH Research Support	001	2	9/8/2023	SUPPLEMENT FOR EXPANSION	$250,296
2023	2023	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	2	4/7/2023	NON-COMPETING CONTINUATION	$602,839
														Subtotal = $853,135

Issue Date FY: 2022 ( Subtotal = $618,968 )
2022	2022	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	001	1	6/23/2022	NEW	$142,105
2022	2022	HEALTHPARTNERS INSTITUTE	8170 33RD AVE S	MINNEAPOLIS	MN	55425	HENNEPIN	USA	Child Health and Human Development Extramural Research	000	1	6/20/2022	NEW	$476,863
														Subtotal = $618,968

Grand Total All Awards = $2,020,105

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Maternal COVID-19 Vaccination and Lactation Outcomes

Award Number: R01HD107753

ORGANIZATION: NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2022

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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