Establishment of the New York University Vaccine and Treatment Evaluation Unit (NYU VTEU) – DMID 21-0004

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PROJECT SUMMARY This is an observational, non-interventional, prospective cohort study designed to collect clinical information and specimens to evaluate the immune responses from approximately 2,000 study participants following maternal receipt of licensed or EUA SARS-CoV-2 vaccines. Pregnant and postpartum individuals and their infants will be screened for study interest and eligibility and enrolled. Study participant groups are as follows: Approximately 2,000 study participants will be enrolled into one of four subject groups:  Group 1: Individuals who receive a Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV- 2) vaccine during pregnancy (up to150 individuals per vaccine type)  Group 2: Individuals who receive a SARS-CoV-2 vaccine postpartum (up to 50 individuals per vaccine type)  Group 3: Infants of individuals who receive vaccine during pregnancy (approximately 150 infants per vaccine type)  Group 4: Infants of individuals who receive vaccine postpartum (approximately 50 infants per vaccine type) Primary objectives are: • Immunogenicity: To describe the kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine in individuals vaccinated during pregnancy, by vaccine type and platform. • Immunogenicity: To describe the transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy, overall and by vaccine type and platform. • Immunogenicity: To describe the kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy, by vaccine type and platform.