To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04754594

Enrollment

726

Registered

2021-02-15

Start date

2021-02-16

Completion date

2022-07-15

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Maternal Immunization, SARS-CoV-2 Infection

Keywords

SARS-CoV-2 Infection, COVID-19, Maternal Immunization

Brief summary

Results will be submitted, however please note that data are not yet available for all serology outcome measures. This will be a Phase 2/3, randomized, placebo-controlled, observer-blind study evaluating the safety, tolerability, and immunogenicity of 30 µg of BNT162b2 or placebo administered in 2 doses, 21 days apart, in approximately 350 healthy pregnant women 18 years of age or older vaccinated at 24 to 34 weeks' gestation. Participants will be randomized 1:1 to receive BNT162b2 or placebo (saline).

Detailed description

The Phase 2 portion of the study will include approximately 200 pregnant women randomized 1:1 to receive BNT162b2 or placebo (saline) at 27 to 34 weeks' gestation. IRC review of safety data through 7 days after the second dose for all Phase 2 participants will be completed. The Phase 3 portion of this study will assess the safety, tolerability, and immunogenicity of BNT162b2 among pregnant women enrolled at 24 to 34 weeks' gestation. Maternal participants who originally received placebo will receive BNT162b2 at defined time points as part of the study.

Interventions

BIOLOGICALBNT162b2

Intramuscular Injection

OTHERPlacebo

Intramuscular Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Healthy women ≥18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at no known increased risk for complications. 2. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study 4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface antigen test during this pregnancy and prior to randomization 5. Participant is willing to give informed consent for her infant to participate in the study 6. Capable of giving signed informed consent

Exclusion criteria

1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19. 3. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine. 4. Participants with known or suspected immunodeficiency. 5. Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection. 6. Previous vaccination with any coronavirus vaccine. 7. Receipt of medications intended to prevent COVID 19. 8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration of study intervention, or planned receipt through delivery, with 1 exception, anti-D immunoglobulin (eg, RhoGAM), which can be given at any time. 9. Current alcohol abuse or illicit drug use. 10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt through the postvaccination blood draw. 11. Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. 12. Previous participation in other studies involving study intervention containing LNPs. 13. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. 14. Participants whose unborn baby has been fathered by investigational site staff members directly involved in the conduct of the study or their family members, site staff members otherwise supervised by the investigator, or Pfizer employees directly involved in the conduct of the study.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	From Day 1 to Day 7 after dose 1	Pain at injection site, redness & swelling were recorded by participants in an electronic diary (e-diary). Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper & Pearson method.
Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	From Day 1 to Day 7 after dose 2	Pain at injection site, redness & swelling were recorded by participants in an e-diary. Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper & Pearson method.
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	From Day 1 to Day 7 after dose 1	Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 degree Celsius (°C) & categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C & \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h & severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	From Day 1 to Day 7 after dose 2	Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 °C & categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C & \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \>2 times in 24 h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h & severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.
Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period	From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)	An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period	From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection	1 Month after Dose 2	GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection	1 Month after Dose 2	GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Secondary

Measure	Time frame	Description
Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age	From birth through 1 month of age	An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age	From birth through 6 months of age	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)	COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.
GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	At birth and 6 months of age	GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMCs of full-length S-binding IgG levels at birth and 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	From birth to 6 months of age	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.
Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age	From birth through 6 months of age	Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection	From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)	COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.
Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)	Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.
Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery	GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery	GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.
Percentage of Infant Participants Reporting Specific Birth Outcomes	At birth	Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.

Countries

Brazil, South Africa, Spain, United Kingdom, United States

Participant flow

Recruitment details

This study was conducted in 2 periods-Blinded Period (from Day 1 to 1 month post-delivery) and Unblinded Period (1 to 6 Months Post-Delivery for those maternal participants who initially received BNT162b2 and from first dose of BNT162b2 to 1 month after second dose of BNT162b2 for those maternal participants who initially received placebo).

Pre-assignment details

A total of 726 participants were enrolled in this study. 391 were maternal participants who signed informed consent form and were enrolled out of which 41 were screen failures and 2 participants were not randomized. Eventually 348 maternal participants were randomized to receive treatment. 335 were infants born to maternal participants.

Participants by arm

Arm	Count
Maternal Participants: BNT162b2 30 mcg Maternal participants received two doses of BNT162b2 30 micrograms (mcg) as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. Participants were followed-up until 6 months post-delivery.	173
Maternal Participants: Placebo Then BNT162b2 30 mcg Maternal participants received two doses of placebo as an intramuscular injection separated by 21 days during their 24 to 34 weeks gestation in the blinded phase. After unblinding at 1 month post-delivery, participants were administered 2 doses of BNT162b2 vaccine as an intramuscular injection separated by 21 days. Participants were followed-up until 1 month after last dose of vaccination.	173
Infant Participants: BNT162b2 30 mcg Infant participants who were born to maternal participants vaccinated with BNT162b2 30 mcg during pregnancy were included. Infant participants were followed up to 6 months of age.	167
Infant Participants: Placebo Infant participants who were born to maternal participants vaccinated with placebo during pregnancy were included. Infant participants were followed up to 6 months of age.	168
Total	681

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Blinded Period	Lost to Follow-up	1	1	0	0
Blinded Period	Protocol Violation	2	2	0	0
Blinded Period	Unblinded before 1-month postdelivery visit	6	3	0	0
Blinded Period	Withdrawal by Subject	4	9	0	0
Infant Participants	Death	0	0	1	1
Infant Participants	Lost to Follow-up	0	0	4	10
Infant Participants	Other	0	0	1	1
Infant Participants	Withdrawal by Subject	0	0	9	17
Unblinded Period	Lost to Follow-up	5	3	0	0
Unblinded Period	Other	3	0	0	0
Unblinded Period	Protocol Violation	2	4	0	0
Unblinded Period	Withdrawal by Subject	6	8	0	0

Baseline characteristics

Characteristic	Total	Maternal Participants: BNT162b2 30 mcg	Maternal Participants: Placebo Then BNT162b2 30 mcg	Infant Participants: BNT162b2 30 mcg	Infant Participants: Placebo
Age, Customized Greater than or equal to (>=) 18 and <= 45 years	346 Participants	173 Participants	173 Participants	0 Participants	0 Participants
Age, Customized Less than (<) 18 years	335 Participants	0 Participants	0 Participants	167 Participants	168 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	258 Participants	70 Participants	63 Participants	65 Participants	60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	415 Participants	103 Participants	110 Participants	98 Participants	104 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants	0 Participants	0 Participants	4 Participants	4 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants	1 Participants	1 Participants	1 Participants	2 Participants
Race (NIH/OMB) Asian	24 Participants	5 Participants	9 Participants	3 Participants	7 Participants
Race (NIH/OMB) Black or African American	170 Participants	47 Participants	43 Participants	40 Participants	40 Participants
Race (NIH/OMB) More than one race	7 Participants	1 Participants	0 Participants	0 Participants	6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	20 Participants	2 Participants	1 Participants	8 Participants	9 Participants
Race (NIH/OMB) White	454 Participants	117 Participants	118 Participants	115 Participants	104 Participants
Sex: Female, Male Female	504 Participants	173 Participants	173 Participants	85 Participants	73 Participants
Sex: Female, Male Male	177 Participants	0 Participants	0 Participants	82 Participants	95 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk	EG008 affected / at risk	EG009 affected / at risk
deaths Total, all-cause mortality	0 / 161	0 / 163	0 / 144	0 / 156	1 / 159	0 / 12	0 / 10	0 / 8	1 / 11	0 / 9
other Total, other adverse events	143 / 161	119 / 163	21 / 144	29 / 156	33 / 159	12 / 12	10 / 10	1 / 8	1 / 11	3 / 9
serious Total, serious adverse events	21 / 161	23 / 163	0 / 144	21 / 156	24 / 159	2 / 12	4 / 10	0 / 8	1 / 11	2 / 9

Outcome results

Primary

Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection

GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 was reported in this outcome measure. Geometric mean titer (GMT) and 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs (based on student t distribution) and was reported in descriptive section. GMR was reported in statistical analysis section of this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of vaccine to which they were randomized, with Dose 2 received within predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: 1 Month after Dose 2

Population: Evaluable immunogenicity population without evidence of SARS-CoV2 infection up to 1 month after Dose 2 was analyzed. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection	1109.2 Titer
Maternal Participants: Placebo	Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection	1663.7 Titer

Comparison: GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.95% CI: [0.5, 0.9]

Primary

GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection

GMR of SARS-CoV-2 neutralizing titers in pregnant women to those in nonpregnant women from study C4591001 (NCT04368728) for evaluable immunogenicity population with and without evidence of prior SARS-CoV-2 infection was reported in this outcome measure. GMT and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution) and was reported in the descriptive section. GMR was reported in the statistical analysis section. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: 1 Month after Dose 2

Population: Evaluable immunogenicity population was analyzed. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection	2198.7 Titer
Maternal Participants: Placebo	GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection	1732.0 Titer

Comparison: GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.95% CI: [0.91, 1.77]

Comparison: GMRs and 2-sided 95% CIs was calculated by exponentiating the mean difference of the logarithms of the assay and the corresponding CIs.95% CI: [0.69, 1.3]

Primary

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1

Pain at injection site, redness & swelling were recorded by participants in an electronic diary (e-diary). Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events in the case report form within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% confidence interval (CI) was based on Clopper & Pearson method.

Time frame: From Day 1 to Day 7 after dose 1

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed (N) signifies participants evaluable for this outcome measure. Human immunodeficiency virus (HIV) positive participants were excluded from analysis as pre-specified in the statistical analysis plan (SAP).

Arm	Measure	Group	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Mild	2.5 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Moderate	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Mild	4.3 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Moderate	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Severe	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Mild	59.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Moderate	23.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Mild	0.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Moderate	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Moderate	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Redness: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Mild	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Pain at the injection site: Mild	9.8 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1	Swelling: Moderate	0 Percentage of participants

Primary

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2

Pain at injection site, redness & swelling were recorded by participants in an e-diary. Redness & swelling were measured & recorded in measuring devise units (range 1 to 21) then converted to cm. 1 measuring device unit = 0.5 cm & graded as mild: \> 2.0 to 5.0 cm, moderate: \> 5.0 to 10.0 cm, severe: \> 10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis (redness) & necrosis (swelling). Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity & grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Grade 4 reactions were classified by the investigator or medically qualified person. Reactions reported as adverse events (AEs) in the case report form (CRF) within 7 days after the study vaccination were also included in the analysis. Exact 2-sided 95% CI was based on the Clopper & Pearson method.

Time frame: From Day 1 to Day 7 after dose 2

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Group	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Mild	3.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Moderate	2.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Mild	4.1 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Moderate	2.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Mild	54.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Moderate	19.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Severe	0.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Mild	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Moderate	4.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Moderate	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Redness: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Mild	0.7 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Pain at the injection site: Mild	12.3 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2	Swelling: Moderate	0 Percentage of participants

Primary

Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period

An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Time frame: From dose 1 on Day 1 through 1 month after delivery (up to 22 weeks)

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period	13.0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period	14.1 Percentage of participants

Primary

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1

Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 degree Celsius (°C) & categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C & \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h & severe: 6 or more loose stools in 24h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.

Time frame: From Day 1 to Day 7 after dose 1

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Group	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Mild	20.5 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >40 deg C (>104.0 deg F)	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Mild	26.1 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Moderate	23.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Severe	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Moderate	11.8 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Severe	1.9 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Mild	5.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Moderate	1.9 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Mild	5.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Moderate	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Mild	11.2 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Moderate	0.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Mild	6.8 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Moderate	5.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Mild	1.2 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Moderate	1.9 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Mild	6.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg Fahrenheit [F])	1.2 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Mild	6.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Moderate	3.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Mild	2.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >40 deg C (>104.0 deg F)	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Mild	20.9 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Moderate	5.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Moderate	21.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Vomiting: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Severe	0.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fatigue/tiredness: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Mild	22.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Mild	7.4 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Moderate	12.9 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Severe	0.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Moderate	1.2 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Headache: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened joint pain: Moderate	2.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Mild	5.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Moderate	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	New or worsened muscle pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Diarrhea: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1	Chills: Grade 4	0 Percentage of participants

Primary

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2

Systemic events were recorded by participants in an e-diary. Fever was oral temperature \>= 38 °C & categorized as \>=38.0 to 38.4 °C, \>38.4 to 38.9 °C, \>38.9 to 40.0 °C & \>40.0 °C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain were graded mild: did not interfere with activity, moderate: some interference with activity & severe: prevented daily routine activity. Vomiting was graded mild: 1 to 2 times in 24 h, moderate: \>2 times in 24 h & severe: required intravenous hydration. Diarrhea was graded mild: 2 to 3 loose stools in 24 h, moderate: 4 to 5 loose stools in 24 h & severe: 6 or more loose stools in 24 h. For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by the investigator/medically qualified person. Systemic events reported as AEs in the CRF within 7 days after vaccination were also included in analysis. Exact 95% CI was based on Clopper & Pearson method.

Time frame: From Day 1 to Day 7 after dose 2

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Group	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Mild	25.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >40 deg C (>104.0 deg F)	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Mild	15.5 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Moderate	32.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Severe	2.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)	1.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Moderate	14.9 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Severe	1.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Mild	4.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Moderate	7.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Severe	0.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Mild	8.8 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Moderate	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Mild	6.1 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Moderate	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Mild	13.5 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Moderate	12.8 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Severe	0.7 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Mild	7.4 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Moderate	6.1 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Severe	0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >=38.0 to 38.4 deg C (100.4 to 101.1 deg F)	0.7 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Mild	2.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >38.4 to 38.9 deg C (101.2 to 102.0 deg F)	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Mild	4.8 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >38.9 to 40.0 deg C (102.1 to 104.0 deg F)	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Moderate	1.4 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fever: >40 deg C (>104.0 deg F)	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Mild	4.8 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Mild	15.8 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Moderate	18.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Moderate	2.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Vomiting: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Fatigue/tiredness: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Mild	13.7 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Mild	4.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Moderate	10.3 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Moderate	1.4 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Headache: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened joint pain: Moderate	1.4 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Mild	0.7 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Moderate	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	New or worsened muscle pain: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Severe	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Diarrhea: Grade 4	0 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2	Chills: Grade 4	0 Percentage of participants

Primary

Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

Time frame: From dose 1 on Day 1 through 1 month after dose 2 (approximately 2 months)

Population: For maternal participants, safety population included all randomized participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period	23.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period	22.7 Percentage of participants

Secondary

COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection

COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants with or without evidence of prior SARS-CoV-2 infection was reported in this outcome measure.

Time frame: From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.270, Placebo- 0.263)

Population: Evaluable efficacy population included all eligible randomized participants who received all vaccinations as randomized, with Dose 2 received within predefined window (within 19-42 days after Dose 1) and had no other important protocol deviations as determined by clinician on or before 7 days after Dose 2. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in SAP.

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection	7.407 Events per 100 person-years
Maternal Participants: Placebo	COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection	11.407 Events per 100 person-years

95% CI: [-466.5, 94.6]

Secondary

COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection

COVID-19 incidence per 100 person-years of blinded follow-up in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to 7 days after receipt of Dose 2 was reported in this outcome measure.

Time frame: From 7 days after Dose 2 up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.155, Placebo- 0.149)

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	12.903 Events per 100 person-years
Maternal Participants: Placebo	COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	13.423 Events per 100 person-years

95% CI: [-1227.8, 93]

Secondary

Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants

GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMCs of full-length S-binding IgG levels in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery

Population: Evaluable immunogenicity population was analyzed. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	6 months after delivery	1639.4 Units/milliliter (U/mL)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	2 weeks after Dose 2	7802.0 Units/milliliter (U/mL)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	1 month after Dose 2	4281.0 Units/milliliter (U/mL)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	At delivery	2747.6 Units/milliliter (U/mL)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	Before Dose 1	2.4 Units/milliliter (U/mL)
Maternal Participants: Placebo	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	Before Dose 1	2.0 Units/milliliter (U/mL)
Maternal Participants: Placebo	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	1 month after Dose 2	1.8 Units/milliliter (U/mL)
Maternal Participants: Placebo	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	2 weeks after Dose 2	1.8 Units/milliliter (U/mL)
Maternal Participants: Placebo	Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants	At delivery	1.7 Units/milliliter (U/mL)

Secondary

Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants

GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for full-length S-binding IgG levels in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	At delivery	1377.6 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	1 month after Dose 2	2276.4 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	6 months after delivery	650.3 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	2 weeks after Dose 2	3618.7 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	1 month after Dose 2	0.9 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	2 weeks after Dose 2	0.9 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants	At delivery	0.8 Fold rise

Secondary

Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants

GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR from before vaccination to each subsequent time point after vaccination for SARS-CoV-2 neutralizing titers in evaluable maternal participants at 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: From before dose 1 up to 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	At delivery	15.6 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	1 month after Dose 2	25.3 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	6 months after delivery	11.3 Fold rise
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	2 weeks after Dose 2	43.7 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	1 month after Dose 2	1.0 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	2 weeks after Dose 2	1.0 Fold rise
Maternal Participants: Placebo	Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	At delivery	1.0 Fold rise

Secondary

Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants

GMTs, and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMTs of SARS-CoV-2 neutralizing titers in evaluable maternal participants at baseline, 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery was reported in this outcome measure. Evaluable immunogenicity population included all participants who were eligible and randomized, received 2 doses of the vaccine to which they were randomized, with Dose 2 received within the predefined window (19-42 days, inclusive, after Dose 1); had at least 1 valid immunogenicity result within an appropriate window 1 month after Dose 2 (28-42 days, inclusive, after Dose 2); and had no other important protocol deviations as determined by the clinician.

Time frame: Baseline (before Dose 1), 2 weeks after Dose 2, 1 month after Dose 2, at delivery, and 6 months after delivery

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	6 months after delivery	465.4 Titer
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	2 weeks after Dose 2	1991.8 Titer
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	1 month after Dose 2	1212.6 Titer
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	At delivery	695.7 Titer
Maternal Participants: BNT162b2 30 mcg	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	Before Dose 1	47.6 Titer
Maternal Participants: Placebo	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	Before Dose 1	43.5 Titer
Maternal Participants: Placebo	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	1 month after Dose 2	43.5 Titer
Maternal Participants: Placebo	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	2 weeks after Dose 2	45.0 Titer
Maternal Participants: Placebo	Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants	At delivery	43.5 Titer

Secondary

GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants

Time frame: At birth and 6 months of age

Population: All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for the specified rows. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	At Birth	5576.4 Units/milliliter (U/mL)
Maternal Participants: BNT162b2 30 mcg	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	6 months of age	311.1 Units/milliliter (U/mL)
Maternal Participants: Placebo	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	At Birth	19.4 Units/milliliter (U/mL)
Maternal Participants: Placebo	GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	6 months of age	22.0 Units/milliliter (U/mL)

Secondary

GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants

GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMFR of full-length S-binding IgG levels from birth to 6 months of age in infant participants born to evaluable maternal participants was reported in this outcome measure.

Time frame: From birth to 6 months of age

Population: All infant participants born to evaluable immunogenicity maternal participants and had no important protocol deviations as determined by the clinician. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (GEOMETRIC_MEAN)
Maternal Participants: BNT162b2 30 mcg	GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	0.1 Fold rise
Maternal Participants: Placebo	GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants	0.6 Fold rise

Secondary

Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection

Incidence of asymptomatic infection of SARS-CoV-2 through 1 month after delivery in evaluable maternal participants without evidence of prior SARS-CoV-2 infection prior to the first post-dose 2 N-binding test was reported in this outcome measure.

Time frame: Up to 1 month after delivery (Surveillance time [100 person-year]: BNT162b2- 0.099, Placebo- 0.147)

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	40.404 Events per 100 person-years
Maternal Participants: Placebo	Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection	68.027 Events per 100 person-years

95% CI: [-104.9, 86.5]

Secondary

Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age

Percentage of infant participants who reported AESI including major congenital anomalies and developmental delay from birth through 6 months of age were reported in this outcome measure. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

Time frame: From birth through 6 months of age

Population: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. HIV positive participants were excluded from analysis as pre-specified in the SAP.

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age	5.1 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age	1.3 Percentage of participants

Secondary

Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age

Time frame: From birth through 1 month of age

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age	35.3 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age	37.1 Percentage of participants

Secondary

Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age

Time frame: From birth through 6 months of age

Arm	Measure	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age	13.5 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age	15.1 Percentage of participants

Secondary

Percentage of Infant Participants Reporting Specific Birth Outcomes

Percentage of infant participants reporting specific birth outcomes (normal, congenital malformation/anomaly, other neonatal problems) were reported in this outcome measure.

Time frame: At birth

Population: Safety population for infant participants included all infant participants born to maternal participants who received at least 1 dose of the study intervention. As this outcome measure was measured at birth, HIV positive infant participants were included in this outcome measure.

Arm	Measure	Group	Value (NUMBER)
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Specific Birth Outcomes	Normal	91.6 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Specific Birth Outcomes	Congenital malformation/anomaly	6.0 Percentage of participants
Maternal Participants: BNT162b2 30 mcg	Percentage of Infant Participants Reporting Specific Birth Outcomes	Other neonatal problem	1.8 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Specific Birth Outcomes	Normal	89.3 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Specific Birth Outcomes	Congenital malformation/anomaly	3.6 Percentage of participants
Maternal Participants: Placebo	Percentage of Infant Participants Reporting Specific Birth Outcomes	Other neonatal problem	6.5 Percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026

To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Geometric Mean Ratio (GMR) of the SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population Without Evidence of Prior SARS-CoV-2 Infection

GMR of SARS-CoV-2 Neutralizing Titers in Pregnant Women to Those in Nonpregnant Women From Study C4591001 (NCT04368728) for Evaluable Immunogenicity Population With and Without Evidence of Prior SARS-CoV-2 Infection

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 1

Percentage of Maternal Participants Reporting Local Reactions Within 7 Days After Dose 2

Percentage of Maternal Participants Reporting Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Delivery - Blinded Follow-up Period

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 1

Percentage of Maternal Participants Reporting Systemic Events Within 7 Days After Dose 2

Percentage of Maternal Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 - Blinded Follow-up Period

COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants With or Without Evidence of Prior SARS-CoV-2 Infection

COVID-19 Incidence Per 100 Person-Years of Blinded Follow up in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection

Geometric Mean Concentration (GMCs) of Full-Length S-Binding Immunoglobulin G (IgG) Levels in Evaluable Maternal Participants

Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for Full-Length S-Binding IgG Levels in Evaluable Maternal Participants

Geometric Mean Fold Rise (GMFR) From Before Vaccination to Each Subsequent Time Point After Vaccination for SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants

Geometric Mean Titer (GMTs) of SARS-CoV-2 Neutralizing Titers in Evaluable Maternal Participants

GMCs of Full-Length S-Binding IgG Levels at Birth and 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants

GMFR of Full-Length S-Binding IgG Levels From Birth to 6 Months of Age in Infant Participants Born to Evaluable Maternal Participants

Incidence of Asymptomatic Infection of SARS-CoV-2 Through 1 Month After Delivery in Evaluable Maternal Participants Without Evidence of Prior SARS-CoV-2 Infection

Percentage of Infant Participants Reporting Adverse Event of Special Interest (AESI) From Birth Through 6 Months of Age

Percentage of Infant Participants Reporting Adverse Events From Birth Through 1 Month of Age

Percentage of Infant Participants Reporting Serious Adverse Events (SAE) From Birth Through 6 Months of Age

Percentage of Infant Participants Reporting Specific Birth Outcomes