$10 million grant will continue UCSD study of COVID-19 vaccinations’ effects during pregnancy and postpartum

With the COVID-19 pandemic ongoing, researchers at the UC San Diego School of Medicine, in collaboration with the American Academy of Allergy, Asthma & Immunology, will continue a national study to evaluate the safety of COVID vaccinations during pregnancy and monitor immune response for mother and baby following vaccinations.

The continuation of the study is made possible by a $10 million, four-year federal grant and involves 1,800 participants.

Published research has indicated that pregnant people are particularly vulnerable to infection with SARS-CoV-2 — the coronavirus that causes COVID-19 — and at higher risk of developing a more serious or complicated disease course, including about a 70 percent increased risk of death. Infection in pregnancy also increases the risk of early delivery and other adverse pregnancy outcomes, including stillbirth.

“Pregnant people are considered a priority population for COVID-19 vaccination. However, only about a third of pregnant persons have chosen vaccination,” said Christina Chambers, a professor in the Department of Pediatrics at UCSD, principal investigator on the Vaccines and Medications in Pregnancy Surveillance System coordinated by AAAAI, and director of the Organization of Teratology Information Specialists MotherToBaby Pregnancy Studies.

“As pregnant persons were not included in the original clinical trials for COVID-19 vaccinations, there is a critical need to do this work to help provide concrete information about the safety and benefits of these vaccines for both mother and baby,” Chambers said.

Using the established U.S. MotherToBaby pregnancy cohort study at UC San Diego, researchers will follow up with 900 women who received one or more doses of any COVID-19 vaccination during pregnancy and 900 who did not. They will evaluate pregnancy outcomes, including major birth defects, miscarriage, stillbirth, preterm delivery and postpartum growth of infants through one year of age.

In a subset of 180 women in the study, researchers will collect blood samples after vaccination in different trimesters of pregnancy to measure the cellular immune response to SARS-CoV-2.

The investigators will study the expansion of T lymphocytes that recognize spike and non-spike regions of the virus. The development of T cell memory, critical to determine long-lasting protection from infection, also will be defined together with the measurement of anti-SARS-CoV-2 antibodies in both mother and baby after delivery.

“The results of this sub-study will provide essential efficacy information that can support COVID-19 vaccine-related public health recommendations in this special population,” said Dr. Alessandra Franco, an immunologist and associate pediatrics professor at UCSD and co-investigator on the study.

“We feel confident that this study will provide important information in support of best clinical practice for obstetric providers and their patients,” said Dr. Michael Schatz, lead AAAAI study coordinator.

The grant funding was provided by the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority through an award made by the National Institute of Child Health and Human Development.

The study will continue enrolling pregnant people through 2024, with final results expected in 2026.

If interested in participating, contact MotherToBaby Pregnancy Studies at mothertobaby.org/pregnancy-studies or call (877) 311-8972. ◆