Table 3 Study Inclusion and Exclusion Criteria

Inclusion Criteria

Pregnant Women

1. Pregnant individuals scheduled to receive or have received complete vaccination series of any licensed or EUA COVID-19 vaccine^a

2. Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures.

Postpartum Women

3. Individuals scheduled to receive or who have initiated vaccination series of any licensed or EUA COVID-19 vaccine within the first 2 months postpartum^b

4. Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures (a separate consent form will be used for their infants).

All participants

5. Understands and agrees to comply with all study procedures.

6. Agrees to sign medical release for herself and her infant to allow study staff to gather pertinent medical information, pregnancy outcome data, and medical information as needed.

Exclusion Criteria

1. Behavioral^c or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant’s ability to participate in the study.

2. Any condition which, in the opinion of the investigators, may pose a health risk to the participant or interferes with the evaluation of the study objectives