PART V: RISK MINIMIZATION MEASURES (INCLUDING EVALUATION OF THE
V.3. Summary of Risk Minimization Measures and Pharmacovigilance Activities
Table Part V.3: Summary Table of Risk Minimization Activities and Pharmacovigilance Activities by Safety Concern
Safety Concern Risk Minimization Measures Pharmacovigilance Activities Important Identified Risks
Anaphylaxis Routine risk minimization measures: beyond adverse reactions reporting and signal detection:
TFUQ for the characterization of anaphylactic/anaphylactoid reactions
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024 Sections 2 and 4 provide recommendations to address the risk of thrombosis with thrombocytopenia syndrome.
Additional risk minimization measures:
Initial DHPC to inform healthcare professionals to facilitate early
detection/diagnosis and correct clinical management of
Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection:
TFUQ for the characterization of venous thromboembolism and Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December
Safety Concern Risk Minimization Measures Pharmacovigilance Activities thrombocytopenia syndrome,
and updated DHPC to
reinforce the initial messages, in particular with regard to the required specialist clinical management of TTS and to emphasize the need to investigate for other TTS symptoms following presentation with post-vaccination thrombosis or thrombocytopenia.
Trial VAC31518COV2001 Final study report: 31 December 2023
Trial VAC31518COV3003 Final study report: 31 March 2024
TV-TEC-207316 – Molecular mimicry of PF4
Final study report: 31 March 2022
TV-TEC-207437 – RNA sequencing of Ad26.COV2.S transduced cells in vitro
Final study report: 31 March 2022
TOX15155 –Study in NZW rabbits to determine spike protein expression after Ad26.COV2.S immunization
Final study report: 31 March 2022
Anti-PF4 antibody levels in immune sera of Ad26.COV2.S immunized animals
Final study report: 31 March 2022
TOX15252 – Systemic exposure to Ad26.COV2.S
Final study report: 31 March 2022
TOX15258 – RNA transcriptome analysis after dosing with
Ad26.COV2.S in Cynomolgus monkey
Final study report: 30 September 2022
Thromboembolic case control study using clinical samples from Ad26.COV2.S studies
Final study report: 31 March 2022
Thromboembolic case control study using clinical samples from Ad26-based Company vaccine studies other than Ad26.COV2.S Final study report: 31 March 2022
Test pre- and post-vaccination serum using clinical samples from Ad26.COV2.S studies
Safety Concern Risk Minimization Measures Pharmacovigilance Activities Ad26-based Company vaccine studies other than Ad26.COV2.S Final study report: 31 March 2022
Test baseline and post-COVID-19 clinical samples
Final study report: 31 March 2022
RNA transcriptome analyses post-vaccination using clinical samples from Ad26.COV2.S and other Ad26-based Company vaccine studies (Trial
VAC18193RSV2008)
Final study report: 30 September 2022 Sections 2 and 4 provide recommendations to address the risk of Guillain-Barré syndrome.
Additional risk minimization measures:
None
Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024 Sections 2 and 4 provide recommendations to address the risk of thrombocytopenia, including immune
thrombocytopenia.
Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 (this study will only address immune
Safety Concern Risk Minimization Measures Pharmacovigilance Activities Additional risk minimization
measures:
DHPC to inform healthcare professionals to consider this risk for individuals with a history of ITP and to facilitate early detection/diagnosis and correct clinical management of ITP.
thrombocytopenia)
Final study report: 30 June 2024
Study VAC31518COV4001 (this study will only address immune thrombocytopenia)
Final study report: 31 December 2024
Trial VAC31518COV2001 Final study report: 31 December 2023
Trial VAC31518COV3003 Final study report: 31 March 2024
TV-TEC-207316 – Molecular mimicry of PF4 (this study will only address immune
thrombocytopenia)
Final study report: 31 March 2022
TV-TEC-207437 – RNA sequencing of Ad26.COV2.S transduced cells in vitro (this study will only address immune
thrombocytopenia)
Final study report: 31 March 2022
TOX15155 –Study in NZW rabbits to determine spike protein expression after Ad26.COV2.S immunization (this study will only address immune
thrombocytopenia)
Final study report: 31 March 2022
Anti-PF4 antibody levels in immune sera of Ad26.COV2.S immunized animals (this study will only address immune
thrombocytopenia)
Final study report: 31 March 2022
TOX15252 – Systemic exposure to Ad26.COV2.S
Final study report: 31 March 2022
TOX15258 – RNA transcriptome analysis after dosing with
Ad26.COV2.S in Cynomolgus monkey
Safety Concern Risk Minimization Measures Pharmacovigilance Activities
RNA transcriptome analyses post-vaccination using clinical samples from Ad26.COV2.S and other Ad26-based Company vaccine studies (Trial
VAC18193RSV2008)
Final study report: 30 September 2022 Sections 2 and 4 provide recommendations to address the risk of VTE.
Additional risk minimization measures:
DHPC to inform healthcare professionals to consider this risk for individuals at
increased risk for VTE and to facilitate early
detection/diagnosis and correct clinical management of VTE.
Routine pharmacovigilance activities beyond adverse reactions reporting and signal detection:
TFUQ for the characterization of venous thromboembolism and Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024
Trial VAC31518COV2001 Final study report: 31 December 2023
Trial VAC31518COV3003 Final study report: 31 March 2024
TOX15252 – Systemic exposure to Ad26.COV2.S
Final study report: 31 March 2022
RNA transcriptome analyses post-vaccination using clinical samples from Ad26.COV2.S and other Ad26-based Company vaccine studies (Trial
VAC18193RSV2008)
Final study report: 30 September 2022
Safety Concern Risk Minimization Measures Pharmacovigilance Activities beyond adverse reactions reporting and signal detection:
TFUQ to collect information on vaccination failure/lack of effect, including events of VAED and VAERD
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4004 Final study report: 30 June 2024 Missing Information
Use in pregnancy and while breastfeeding beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3001 (This trial will only address use while breastfeeding)
Final study report: 31 December 2023
Trial VAC31518COV3009 (This trial will only address use while breastfeeding)
Final study report: 30 June 2024
Trial VAC31518COV2004 Final study report: 30 September 2023
Study VAC31518COV4005 (This study will only address use in pregnancy)
Final study report: 30 June 2027
Safety Concern Risk Minimization Measures Pharmacovigilance Activities Ad26.COV2.S in breastfeeding women will not be studied.) Final study report: 30 June 2024 Use in beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Interventional trial to evaluate the safety and immunogenicity of Ad26.COV2.S in
immunocompromised patients Final study report: 30 June 2023
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4004 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024
Study VAC31518COV4002 Final study report: 31 December 2024
Use in patients with autoimmune or beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024
Safety Concern Risk Minimization Measures Pharmacovigilance Activities Use in frail patients
with comorbidities beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Study VAC31518COV4003 Final study report: 30 June 2024
Study VAC31518COV4001 Final study report: 31 December 2024
Study VAC31518COV4002 Final study report: 31 December 2024 beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3005 Final study report: 31 December 2023
Long-term safety Routine risk minimization measures: beyond adverse reactions reporting and signal detection:
None
Additional pharmacovigilance activities:
Trial VAC31518COV3001 Final study report: 31 December 2023
Trial VAC31518COV3009 Final study report: 30 June 2024
Study VAC31518COV4003 Final study report: 30 June 2024
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN