This study will provide robust safety and effectiveness information regarding COVID-19 vaccinations during pregnancy that will allow pregnant people and their caregivers to make the most informed benefit-risk decisions.
MILWAUKEE (PRWEB) June 25, 2022
Researchers at the University of California San Diego School of Medicine and the American Academy of Allergy, Asthma & Immunology (AAAAI) are collaborating in a study to further examine the safety of the COVID-19 vaccinations during pregnancy, including the strength of the immune response for mother and baby both pre- and post-delivery following vaccination.
Researchers say the expanded study is necessary since pregnant people were not included in the original clinical trials for COVID-19 vaccines. “Vaccinations and medications are typically inadequately studied during pregnancy, leading to potential underuse,” said Michael Schatz, MD, MS, FAAAAI, the principal investigator on the project for the AAAAI. “This study will provide robust safety and effectiveness information regarding COVID-19 vaccinations during pregnancy that will allow pregnant people and their caregivers to make the most informed benefit-risk decisions.”
The first two years of the pandemic showed that pregnant people are particularly vulnerable to SARS-CoV-2 and at risk of developing more serious disease. Risk of preterm delivery, as well as other adverse pregnancy outcomes, such as stillbirth, were also elevated among those infected. Despite this, only about a third of pregnant persons have chosen vaccination, Schatz said.
The continuation of the national study is being funded by a recent $10 million, 4-year grant awarded by the National Institutes of Health (NIH) – Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA). The Organization of Teratology Information Specialists (OTIS) Studies program and the AAAAI have worked together in the Vaccines and Medications in Pregnancy Surveillance Systems (VAMPSS) studies like this for 15 years.
Using the established U.S. MotherToBaby pregnancy cohort study at UC Sand Diego, researchers will follow-up with 900 individuals 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.
Researchers will also look at blood samples of a subset of 180 people to determine the immune response following COVID-19 vaccinations during pregnancy and the presence of antibodies to SARS-CoV-2 in both mother and baby after delivery.
“The AAAAI is very proud of the ongoing work of the VAMPSS team and their continued efforts at expanding our knowledge of the safety of vaccines and medications during pregnancy,” said AAAAI President David Khan, MD, FAAAAI. “We’re delighted that this important study is continuing.”
The American Academy of Allergy, Asthma & Immunology (AAAAI) is the leading membership organization of more than 7,100 allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. The AAAAI is the go-to resource for patients living with allergies, asthma and immune deficiency disorders. Established in 1943, the AAAAI has more than 7,100 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.