Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Incidence of COVID-19 Infection Among Pregnant Individuals |
The effectiveness of SARS-CoV-2 vaccines against maternal COVID-19 infection during pregnancy and postpartum will be assessed as the incidence of laboratory confirmed COVID-19 illness during study participation assessed through passive surveillance in individuals vaccinated during pregnancy or postpartum compared to rates in unvaccinated women of childbearing age, overall and by vaccine type and platform. |
Up to postpartum month 12 |
|
Other |
Severity of COVID-19 Infection Among Pregnant Individuals |
The effectiveness of SARS-CoV-2 vaccines against maternal COVID-19 infection during pregnancy and postpartum will be assessed as the severity of COVID-19 disease during study participation assessed through passive surveillance in individuals vaccinated during pregnancy or postpartum compared to rates in unvaccinated women of childbearing age, overall and by vaccine type and platform. |
Up to postpartum month 12 |
|
Other |
Incidence of COVID-19 Infection Among Infants |
The effectiveness of maternal antibodies to provide protection against SARS-CoV-2 will be assessed by examining the incidence of COVID-19 illness in infants in the first 12 months of life. Incidence of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in infants of individuals vaccinated in pregnancy or postpartum compared to background rates in infants of unvaccinated women of childbearing age, overall and by vaccine type and platform. |
Up to 12 months of age |
|
Other |
Severity of COVID-19 Infection Among Infants |
The effectiveness of maternal antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in infants of individuals vaccinated in pregnancy or postpartum vs. background rates in infants of unvaccinated women of childbearing age, overall and by vaccine type and platform. |
Up to 12 months of age |
|
Other |
Incidence of COVID-19 Infection Among Breastfed Infants |
The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the incidence of COVID-19 illness in infants in the first 12 months of life. The incidence of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants compared to not breastfed infants, by vaccine type and platform. |
Up to 12 months of age |
|
Other |
Severity of COVID-19 Infection Among Breastfed Infants |
The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants compared to not breastfed infants, by vaccine type and platform. |
Up to 12 months of age |
|
Other |
Incidence of COVID-19 Infection Among Breastfed Infants by Vaccination Timing |
The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants of individuals vaccinated during pregnancy compared to postpartum, overall and by vaccine type and platform. |
Up to 12 months of age |
|
Other |
Severity of COVID-19 Infection Among Breastfed Infants by Vaccination Timing |
The effectiveness of breastmilk antibodies to provide protection against SARS-CoV-2 will be assessed by examining the severity of COVID-19 illness in infants in the first 12 months of life. The severity of laboratory confirmed COVID-19 during study participation is assessed through passive surveillance in breastfed infants of individuals vaccinated during pregnancy compared to postpartum, overall and by vaccine type and platform. |
Up to 12 months of age |
|
Primary |
Change in Geometric Mean Titer (GMT) of Serum Immunoglobulin G (IgG) Among Individuals Vaccinated During Pregnancy |
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of IgG enzyme-linked immunosorbent assay (ELISA), by vaccine type and/or platform (mRNA, viral vector, etc.). |
Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12 |
|
Primary |
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated During Pregnancy |
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine during pregnancy will be assessed as the GMT of Neut antibodies by vaccine type, platform and dose regimen. |
Baseline, 28 days post-vaccination, at delivery, postpartum months 2, 6, and 12 |
|
Primary |
GMT of Cord Blood IgG |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, overall and by vaccine type, platform and dose regimen. |
At delivery |
|
Primary |
Ratio of Cord Blood IgG to Maternal Serum IgG |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, overall and by vaccine type, platform and dose regimen. |
At delivery |
|
Primary |
Neut antibodies of cord blood |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in cord blood, overall and by vaccine type, platform and dose regimen. |
At delivery |
|
Primary |
Ratio of cord blood Neut antibodies to maternal serum Neut antibodies |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, overall and by vaccine type and platform. |
At delivery |
|
Primary |
Change GMT of serum IgG in Infants Born to Individuals Vaccinated During Pregnancy |
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of IgG in infants, by vaccine type, platform and dose regimen. |
At delivery, 2 months of age, 6 months of age |
|
Primary |
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated During Pregnancy |
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated during pregnancy will be assessed as the GMT of Neut antibodies in infants, by vaccine type, platform and dose regimen. |
At delivery, 2 months of age, 6 months of age |
|
Secondary |
Frequency of Maternal Outcomes |
The frequency of maternal outcomes among individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform. |
At delivery |
|
Secondary |
Frequency of Infant Outcomes |
The frequency of infant outcomes among infants born to individuals receiving the SARS-CoV-2 vaccine during pregnancy or postpartum will be compared to background rates in the United States, overall and by vaccine type and platform. |
At delivery |
|
Secondary |
GMT of Serum IgG Compared to Non-Pregnant Women |
GMT of Serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age. |
28 days post-vaccination |
|
Secondary |
GMT of Neut Antibodies Compared to Non-Pregnant Women |
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be compared to non-pregnant populations of women of childbearing age. |
28 days post-vaccination |
|
Secondary |
GMT of Serum IgG by Gestational Age at Vaccination |
GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform. |
28 days post-vaccination |
|
Secondary |
GMT of Neut Antibodies by Gestational Age at Vaccination |
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy will be examined by gestational age at vaccination (trimester of gestation) and interval between vaccination and delivery, by vaccine type and platform. |
28 days post-vaccination |
|
Secondary |
GMT of Serum IgG by Baseline Characteristics |
GMT of serum IgG in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
28 days post-vaccination |
|
Secondary |
GMT of Neut Antibodies by Baseline Characteristics |
GMT of Neut antibodies in individuals receiving different SARS-CoV-2 vaccines during pregnancy or postpartum will be examined by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
28 days post-vaccination |
|
Secondary |
GMT of Cord Blood IgG by Gestational Age at Vaccination |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform. |
At delivery |
|
Secondary |
Ratio of Cord Blood IgG to Maternal Serum IgG by Gestational Age at Vaccination |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform. |
At delivery |
|
Secondary |
GMT of Cord Blood Neut Antibodies by Gestational Age at Vaccination |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform. |
At delivery |
|
Secondary |
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Gestational Age at Vaccination |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by gestational age at vaccination (trimester of vaccination) and interval between vaccination and delivery, overall and by vaccine type and/or platform. |
At delivery |
|
Secondary |
GMT of Cord Blood IgG by Baseline Characteristics |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT of IgG in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
At delivery |
|
Secondary |
Ratio of Cord Blood IgG to Maternal Serum IgG by Baseline Characteristics |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood IgG to maternal serum IgG, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
At delivery |
|
Secondary |
GMT of Cord Blood Neut Antibodies by Baseline Characteristics |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the GMT Neut antibodies in cord blood, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
At delivery |
|
Secondary |
Ratio of Cord Blood Neut Antibodies to Maternal Serum Neut Antibodies by Baseline Characteristics |
Transplacental antibody transfer of SARS-CoV-2 antibodies among individuals vaccinated during pregnancy will be assessed as the ratio of cord blood Neut antibodies to maternal Neut antibodies, by maternal age, health status, and risk status (e.g., occupation, priority vaccination group) overall and by vaccine type and platform. |
At delivery |
|
Secondary |
Change in GMT of IgG in Breast Milk |
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgG in breast milk, overall and by vaccine type and platform. |
2 weeks postpartum, and 2, 6, and 12 months postpartum |
|
Secondary |
Change in GMT of Immunoglobulin A (IgA) in Breast Milk |
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of IgA in breast milk, overall and by vaccine type and platform. |
2 weeks postpartum, and 2, 6, and 12 months postpartum |
|
Secondary |
Change in GMT of Neut Antibodies in Breast Milk |
The kinetics of SARS-CoV-2 antibodies in breast milk of mothers who received vaccine during pregnancy or postpartum, will be assessed as the GMT of Neut Antibodies in breast milk, overall and by vaccine type and platform. |
2 weeks postpartum, and 2, 6, and 12 months postpartum |
|
Secondary |
Change in GMT of Serum IgG Among Individuals Vaccinated Postpartum |
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of IgG, by vaccine type and/or platform. |
Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 |
|
Secondary |
Change in GMT of Neutralizing (Neut) Antibodies in Serum Among Individuals Vaccinated Postpartum |
The kinetics and durability of maternal serum antibodies following receipt of SARS-CoV-2 vaccine postpartum will be assessed as the GMT of Neut antibodies, by vaccine type and/or platform. |
Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 |
|
Secondary |
Change GMT of serum IgG in Infants Born to Individuals Vaccinated Postpartum |
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of IgG in infants, by vaccine type and platform. |
2 months of age, 6 months of age |
|
Secondary |
Change GMT of Neut antibodies in Infants Born to Individuals Vaccinated Postpartum |
The kinetics and durability of serum SARS-CoV-2 antibodies in infants of mothers vaccinated postpartum will be assessed as the GMT of Neut antibodies in infants, by vaccine type and platform. |
2 months of age, 6 months of age |
|
Secondary |
Change in GMT of Serum IgG Among Individuals Receiving Additional Vaccine Dose(s) |
The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of IgG in serum, by vaccine type and platform. |
Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 |
|
Secondary |
Change in GMT of Neut Antibodies Among Individuals Receiving Additional Vaccine Dose(s) |
The kinetics and durability of maternal serum antibodies following receipt of additional dose(s) of SARS-CoV-2 vaccine in pregnant individuals who received vaccine prior to pregnancy, will be assessed as the GMT of Neut antibodies, by vaccine type and platform. |
Baseline, 28 days post-vaccination, postpartum months 2, 6, and 12 |
|