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

1. pregnant or lactating 2. has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. 3. history of anaphylaxis or angioedema 4. active sars-cov-2 infection at enrolment, based on dna-pcr testing 5. discordant rdt result 6. history of severe or multiple allergies to drugs or pharmaceutical agents 7. history of severe local or general reaction to vaccination defined as: 1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 2. general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours 8. ever received an experimental vaccine against covid-19 9. receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 10. detection of antibodies to hepatitis c 11. detection of antibodies to hiv 12. grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download 13. participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. 14. has received an immunisation within 28 days of screening 15. has received an authorised covid-19 vaccine

1. pregnant or lactating 2. has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. 3. history of anaphylaxis or angioedema 4. active sars-cov-2 infection at enrolment, based on dna-pcr testing 5. discordant rdt result 6. history of severe or multiple allergies to drugs or pharmaceutical agents 7. history of severe local or general reaction to vaccination defined as: 1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 2. general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours 8. ever received an experimental vaccine against covid-19 9. receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 10. detection of antibodies to hepatitis c 11. detection of antibodies to hiv 12. grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download 13. participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. 14. has received an immunisation within 28 days of screening 15. has received an authorised covid-19 vaccine

Nov. 16, 2021, 6:30 p.m. usa

pregnant or lactating has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. history of anaphylaxis or angioedema active sars-cov-2 infection at enrolment, based on dna-pcr testing discordant rdt result history of severe or multiple allergies to drugs or pharmaceutical agents history of severe local or general reaction to vaccination defined as: local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours ever received an experimental vaccine against covid-19 receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical detection of antibodies to hepatitis c detection of antibodies to hiv grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. has received an immunisation within 28 days of screening has received an authorised covid-19 vaccine

pregnant or lactating has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. history of anaphylaxis or angioedema active sars-cov-2 infection at enrolment, based on dna-pcr testing discordant rdt result history of severe or multiple allergies to drugs or pharmaceutical agents history of severe local or general reaction to vaccination defined as: local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours ever received an experimental vaccine against covid-19 receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical detection of antibodies to hepatitis c detection of antibodies to hiv grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. has received an immunisation within 28 days of screening has received an authorised covid-19 vaccine

June 24, 2021, 2 a.m. usa

1. pregnant or lactating 2. has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. 3. history of anaphylaxis or angioedema 4. active sars-cov-2 infection at enrolment, based on dna-pcr testing 5. discordant rdt result 6. history of severe or multiple allergies to drugs or pharmaceutical agents 7. history of severe local or general reaction to vaccination defined as: 1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 2. general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours 8. ever received an experimental vaccine against covid-19 9. receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 10. detection of antibodies to hepatitis c 11. detection of antibodies to hiv 12. grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download 13. participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. 14. has received an immunisation within 28 days of screening 15. has received an authorised covid-19 vaccine

1. pregnant or lactating 2. has a significant clinical history, physical finding on clinical examination during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, increases the risk of severe covid-19, may compromise the volunteer's safety, preclude vaccination or compromise interpretation of the immune response to vaccine. individuals with mild/moderate, well-controlled comorbidities are allowed. 3. history of anaphylaxis or angioedema 4. active sars-cov-2 infection at enrolment, based on dna-pcr testing 5. discordant rdt result 6. history of severe or multiple allergies to drugs or pharmaceutical agents 7. history of severe local or general reaction to vaccination defined as: 1. local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours 2. general: fever ≥39.5 °c within 48 hours; bronchospasm; laryngeal edema; collapse; convulsions or encephalopathy within 72 hours 8. ever received an experimental vaccine against covid-19 9. receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 10. detection of antibodies to hepatitis c 11. detection of antibodies to hiv 12. grade 1 and above abnormalities in routine laboratory parameters using the fda toxicity table toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. https://www.fda.gov/media/73679/download 13. participating in another clinical trial with an investigational drug or device, or treated with an investigational drug within 28 days of screening. 14. has received an immunisation within 28 days of screening 15. has received an authorised covid-19 vaccine