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  1. Advancing Regulatory Science

Defining SARS-CoV-2 vaccine-induced immunity in pregnant and lactating people

CERSI Collaborators: Caleb Alexander, MD, Sabra Klein, PhD, Irina Burd, MD, PhD, Andrea Cox, MD, PhD, Andrew Pekosz, PhD, Heba Mostafa, MD, PhD

FDA Collaborators: Catherine Sewell, MD, MPH, Hana Golding, PhD, Sara Head, PhD, MPH, Leah Berhane, MD, Susan Bersoff-Matcha, MD

Project Start Date: September 1, 2021

Regulatory Science Challenge

The U.S. Centers for Disease Control (CDC) lists pregnancy as an underlying condition that can increase the risk for severe COVID-19 outcomes. SARS-CoV-2-infected pregnant people do not produce adequate antibody responses against the virus, which may lead to increased risk of severe outcomes. Vaccination has been shown to provide the best protection against SARS-CoV-2-induced illness. However, data on COVID-19 vaccinations in pregnancy are lacking since pregnant patients were excluded from the clinical trials of the COVID-19 vaccines that led to their original approval for use in the U.S. (although a few people did become pregnant during the trials with no negative outcome). Following rollout of COVID-19 vaccines, the CDC strongly recommends vaccination for people who are pregnant and breastfeeding.

Our study directly addresses the significant regulatory science gap in evaluating FDA-regulated SARS-CoV-2 vaccines for protection of pregnant or lactating people against COVID-19 with emphasis on identification of possible protective factors that might be different between pregnant than nonpregnant people. This study may provide valuable data to the FDA on how immune responses (reaction to infection) change as a function of pregnancy, as well as how pregnancy may affect the body’s response to the COVID-19 vaccines, which will inform future clinical study design in such populations. Finally, through characterization of viruses in breakthrough infections (those that results in symptoms for the patient), this study will advance understanding of protective immune responses and the genetic mechanisms utilized by viruses to escape that immunity, all of which are relevant to regulation of SARS-CoV-2 vaccines and booster doses.

Project Description and Goals

Our study directly addresses the significant regulatory science gap in evaluating FDA-regulated SARS-CoV-2 vaccines for protection of pregnant or lactating people against COVID-19 with emphasis on identification of possible protective factors that might be different between pregnant than nonpregnant people. This study may provide valuable data to the FDA on how immune responses (reaction to infection) change as a function of pregnancy, as well as how pregnancy may affect the body’s response to the COVID-19 vaccines, which will inform future clinical study design in such populations. Finally, through characterization of viruses in breakthrough infections (those that results in symptoms for the patient), this study will advance understanding of protective immune responses and the genetic mechanisms utilized by viruses to escape that immunity, all of which are relevant to regulation of SARS-CoV-2 vaccines and booster doses.

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