よむ、つかう、まなぶ。
参考資料13 Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting Presentation - FDA Review of Effectiveness and Safety of Novavax COVID-19 Vaccine in Adults > 18 Years of Age - Emergency Use Authorization Request（Vaccines and Related Biological Products Advisory Committee June 7, 2022 Meeting FDA提出資料） (42 ページ)
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Pharmacovigilance Plan
Important identified risks
FDA recommends adding myocarditis and pericarditis
Important potential risks
Vaccine-associated enhanced disease including vaccine-associated enhanced respiratory
disease, myocarditis and pericarditis, and anaphylaxis
Missing information
Use in pregnancy and while breast feeding, use in immunocompromised patients, use in
frail patients with comorbidities (e.g., chronic obstructive pulmonary disease, diabetes,
chronic neurological disease, cardiovascular disorders), use in patients with autoimmune or
inflammatory disorders, interaction with other vaccines, and long-term safety
Surveillance activities
•
•
Passive surveillance activities will include submitting spontaneous reports of the
following events to the Vaccine Adverse Event Reporting System (VAERS) within 15
days: Serious adverse events (irrespective of attribution to vaccination); Cases of
Multisystem Inflammatory Syndrome in adults; Cases of COVID-19 that result in
hospitalization or death
The Sponsor will conduct:
• Passive and active surveillance activities for continued vaccine safety monitoring.
• Periodic aggregate review of safety data and submit periodic safety reports
• Five planned surveillance studies, including active follow-up studies for safety in
the US and UK
41
Important identified risks
FDA recommends adding myocarditis and pericarditis
Important potential risks
Vaccine-associated enhanced disease including vaccine-associated enhanced respiratory
disease, myocarditis and pericarditis, and anaphylaxis
Missing information
Use in pregnancy and while breast feeding, use in immunocompromised patients, use in
frail patients with comorbidities (e.g., chronic obstructive pulmonary disease, diabetes,
chronic neurological disease, cardiovascular disorders), use in patients with autoimmune or
inflammatory disorders, interaction with other vaccines, and long-term safety
Surveillance activities
•
•
Passive surveillance activities will include submitting spontaneous reports of the
following events to the Vaccine Adverse Event Reporting System (VAERS) within 15
days: Serious adverse events (irrespective of attribution to vaccination); Cases of
Multisystem Inflammatory Syndrome in adults; Cases of COVID-19 that result in
hospitalization or death
The Sponsor will conduct:
• Passive and active surveillance activities for continued vaccine safety monitoring.
• Periodic aggregate review of safety data and submit periodic safety reports
• Five planned surveillance studies, including active follow-up studies for safety in
the US and UK
41