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positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease as per current cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation. presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt or planned receipt during the study period of a covid-19 vaccine (except for prior doses of the pfizer covid vaccine (comirnaty®) in subjects enrolled in group 3). close contact of anyone known to have sars-cov-2 infection within 14 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease as per current cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation. presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt or planned receipt during the study period of a covid-19 vaccine (except for prior doses of the pfizer covid vaccine (comirnaty®) in subjects enrolled in group 3). close contact of anyone known to have sars-cov-2 infection within 14 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt or planned receipt during the study period of a covid-19 vaccine. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt or planned receipt during the study period of a covid-19 vaccine. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt of a covid19 vaccine. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

positive pregnancy test either at screening or just prior to vaccine administration. female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* presence of self-reported or medically documented significant medical or psychiatric condition(s). has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness anticipating the need for immunosuppressive treatment within the next 6 months. received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. has any blood dyscrasias or significant disorder of coagulation. has any chronic liver disease, including fatty liver. has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. receipt of a covid19 vaccine. close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. history of covid-19 diagnosis (positive test for antigen or pcr or antibody). on current treatment with investigational agents for prophylaxis of covid-19. plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. non-ambulatory. for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

- positive pregnancy test either at screening or just prior to vaccine administration. - female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. - anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html> ) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* - presence of self-reported or medically documented significant medical or psychiatric condition(s). - has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. - has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. - has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. - currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. - has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. - has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. - chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness - anticipating the need for immunosuppressive treatment within the next 6 months. - received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. - has any blood dyscrasias or significant disorder of coagulation. - has any chronic liver disease, including fatty liver. - has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. - received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. - received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. - receipt of a covid19 vaccine. - close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. - history of covid-19 diagnosis (positive test for antigen or pcr or antibody). - on current treatment with investigational agents for prophylaxis of covid-19. - plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. - reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. - non-ambulatory. - for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.

- positive pregnancy test either at screening or just prior to vaccine administration. - female subject who is breastfeeding or plans to breastfeed from the time of the vaccination through 60 days after vaccination. - anyone at high risk of severe covid-19 disease e.g. those with hypertension, hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per cdc guidance (< https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html> ) or has any medical disease or condition that, in the opinion of the participating site pi or appropriate sub-investigator, precludes trial participation.* - presence of self-reported or medically documented significant medical or psychiatric condition(s). - has an acute illness, as determined by the participating site pi or appropriate sub-investigator, with or without fever [oral temperature ≥ 38.0° celsius (100.4° fahrenheit)] within 72 hours of vaccination. - has a positive test result for hepatitis b surface antigen, hepatitis c virus antibody, or human immunodeficiency virus (hiv) types 1 or 2 antibodies at screening. - has participated in another investigational trial involving any investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) within 60 days, or 5 half-lives, whichever is longer, before vaccine administration. - currently enrolled in or plans to participate in another clinical trial with an investigational product (unlicensed vaccine, drug, biologic, device, blood product, or medication) that will be received during the trial-reporting period. - has previously participated in an investigational trial of prophylaxis or treatment for sars-cov-2 infection or covid-19 disease. - has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines. - chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness - anticipating the need for immunosuppressive treatment within the next 6 months. - received immunoglobulins and/or any blood or blood products within the 4 months before vaccine administration or at any time during the trial. - has any blood dyscrasias or significant disorder of coagulation. - has any chronic liver disease, including fatty liver. - has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 6 months before vaccine administration. - received or plans to receive a licensed, live vaccine within 4 weeks before or after vaccination. - received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after vaccination. - receipt of a covid19 vaccine. - close contact of anyone known to have sars-cov-2 infection within 30 days prior to vaccine administration. - history of covid-19 diagnosis (positive test for antigen or pcr or antibody). - on current treatment with investigational agents for prophylaxis of covid-19. - plan to travel outside the united states (us) (continental us, hawaii, and alaska) from enrollment through 28 days after vaccination. - reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care. - non-ambulatory. - for subjects of any age, individuals currently working with high risk of exposure to sars-cov-2.