Created at Source Raw Value Validated value
June 25, 2024, noon usa

* participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) * participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) * participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) * participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood * participant has a positive diagnostic test result (polymerase chain reaction \[pcr\] based viral ribonucleic acid \[rna\] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) * participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) * participant has a history of capillary leak syndrome (cls)

* participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) * participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) * participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) * participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood * participant has a positive diagnostic test result (polymerase chain reaction \[pcr\] based viral ribonucleic acid \[rna\] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) * participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) * participant has a history of capillary leak syndrome (cls)

July 1, 2022, 11 p.m. usa

participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) participant has a history of capillary leak syndrome (cls)

participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) participant has a history of capillary leak syndrome (cls)

June 9, 2022, 4 p.m. usa

None

None

Jan. 16, 2022, 10:30 a.m. usa

participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) participant has a history of capillary leak syndrome (cls)

participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy) participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence) participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) participant has a history of capillary leak syndrome (cls)

Aug. 31, 2021, 8:30 p.m. usa

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) - participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) - participant has a history of capillary leak syndrome (cls)

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between) - participant has a history of thrombosis with thrombocytopenia syndrome (tts), including cerebral venous sinus thrombosis (cvst), or heparin-induced thrombocytopenia (hit) - participant has a history of capillary leak syndrome (cls)

Aug. 6, 2021, 3 p.m. usa

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)

March 11, 2021, 12:31 a.m. usa

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result for past (serological testing) or current (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any serious, chronic, or progressive neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result for past (serological testing) or current (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)

Feb. 23, 2021, 12:31 a.m. usa

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result for past (serological testing) or current (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)

- participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, preeclampsia, premature birth during previous pregnancy) - participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen) - participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence - participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) - participant has a history of any neurological disorders or seizures including guillain-barre syndrome, with the exception of febrile seizures during childhood - participant has a positive diagnostic test result for past (serological testing) or current (polymerase chain reaction [pcr] based viral ribonucleic acid [rna] detection) severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection at screening or day 1 (if more than 4 days in between)