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Uptake, Safety and Effectiveness of COVID‐19 Vaccines during Pregnancy

Award Number: R01AI169239
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: 04/08/2022
PERIOD OF PERFORMANCE END DATE: 03/10/2025

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Uptake, Safety and Effectiveness of COVID‐19 Vaccines during Pregnancy - PROJECT SUMMARY Pregnant persons are at increased risk for severe COVD-19 illness compared to non-pregnant women of reproductive age, experiencing higher rates of admission to intensive care, mechanical ventilation and death. In addition to the direct impacts on the health of pregnant persons, there is growing evidence to suggest COVID-19 adversely impacts fetal and neonatal health. As of May 2021, three vaccines have been issued Emergency Use Approval in the US. However, because pregnant persons were excluded from initial Phase 3 clinical trials, data to confirm the safety and effectiveness of COVID-19 vaccination during pregnancy are lacking. Driven by this limited data, obstetric and public health governing bodies do not currently directly recommend vaccination for pregnant persons. The American College of Obstetricians and Gynecologists and the US Centers for Disease Control and Prevention (CDC) advise that COVID-19 vaccines should not be withheld from pregnant persons. As a result, the decision to vaccinate is made at the individual level, and pregnant persons express anxiety around making this decision. Additional data to inform the safety and effectiveness of COVID-19 vaccines administered during pregnancy would strengthen current clinical guidelines. Despite weak guidance, individuals are choosing to be vaccinated during pregnancy. As of 3 May 2021, 106,241 pregnant persons were reported as having received a COVID-19 vaccine through V-SAFE, the CDC’s active vaccine safety surveillance system. When surveyed, more than 50% of pregnant persons report an intention to receive a COVID-19 vaccine. Phase 2/3 clinical trial data are currently being gathered to evaluate safety and efficacy. While these clinical trial data are being collected, we have the opportunity to learn from large observational studies of pregnant persons who have chosen to be vaccinated. Leveraging existing national medical claims and electronic medical records for more than 870,000 pregnancies, we plan to conduct large-scale post-implementation cohort studies to evaluate the uptake, safety and effectiveness of COVID-19 vaccines administered during pregnancy. Completion of the proposed research will provide important epidemiological evidence on the safety and effectiveness of COVID-19 vaccination during pregnancy. This evidence will aid informed decision and policy-making around COVID-19 vaccination for pregnant persons.


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	UNIVERSITY OF SAN FRANCISCO	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	3/10/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $382,426 )
2024	2024	UNIVERSITY OF SAN FRANCISCO	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	3	3/27/2024	NON-COMPETING CONTINUATION	$382,426
														Subtotal = $382,426

Issue Date FY: 2023 ( Subtotal = $383,326 )
2023	2023	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	2	3/7/2023	NON-COMPETING CONTINUATION	$383,326
														Subtotal = $383,326

Issue Date FY: 2022 ( Subtotal = $511,677 )
2022	2022	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	000	1	4/7/2022	NEW	$511,677
2022	2022	UNIVERSITY OF SAN FRANCISCO INC	2130 FULTON ST	SAN FRANCISCO	CA	94117	SAN FRANCISCO	USA	Allergy and Infectious Diseases Research	001	1	4/21/2022	NEW	$0
														Subtotal = $511,677

Grand Total All Awards = $1,277,429

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Uptake, Safety and Effectiveness of COVID‐19 Vaccines during Pregnancy

Award Number: R01AI169239

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: 04/08/2022

PERIOD OF PERFORMANCE END DATE: 03/10/2025

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