SARS-CoV-2 Vaccine Pregnancy Registry

NIH RePORTER · NIH · U24 · $250,000 · view on reporter.nih.gov ↗

Abstract

PROJECT SUMMARY SARS-CoV-2 was first detected in December 2019 and rapidly spread to become a pandemic. Pregnant people are one of the groups at high-risk for morbidity and mortality. It is safe to assume that pregnant people will continue to be exposed to SARS-CoV-2 vaccination. SARS- CoV-2 vaccination continues to date, and boosters are likely to be recommended on an annual basis. There is limited information regarding the potential long-term benefit from fetal exposure to SARS-CoV-2 vaccine, and most of the data are from self-reported surveys or administrative databases. One of concern about exposures to infections in pregnancy focuses on neurodevelopmental outcomes of the offspring. We propose a multi-center prospective observational study of the offspring of 500 individuals that did and did not receive a SARS-CoV-2 vaccine during pregnancy. The proposed study will leverage the MFMU Network’s large and robust research infrastructure to evaluate if SARS- CoV-2 vaccines are associated with improved neurodevelopmental outcomes in the offspring, which has been a neglected area of investigation with regard to COVID-19. The aims of this project are, Aim 1: To identify a cohort of individuals who received the SARS-CoV-2 vaccine during pregnancy or within 30 days prior to pregnancy and compare the developmental outcomes of their infants at age 24 months with those who did not receive the vaccine during pregnancy or within 30 days prior to pregnancy. Aim 2: Compare specific developmental outcomes of the offspring at age 24 months of those who received SARS-CoV-2 vaccine during pregnancy or within 30 days prior to pregnancy with those who did not Aim 3: Compare behavioral outcomes of the offspring at age 24 months of those who received SARS-CoV-2 vaccine during pregnancy or within 30 days prior to pregnancy with those who did not. Aim 4: Compare autism screening test outcomes of the offspring at age 24 months of those who received SARS-CoV-2 vaccine during pregnancy or within 30 days prior to pregnancy with those who did not.

Key facts

NIH application ID
10879795
Project number
3U24HD036801-26S1
Recipient
GEORGE WASHINGTON UNIVERSITY
Principal Investigator
Rebecca Gersnoviez Clifton
Activity code
U24
Funding institute
NIH
Fiscal year
2023
Award amount
$250,000
Award type
3
Project period
1998-04-15 → 2030-03-31