None listed
Conditions
Brief summary
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine. To address this gap in important knowledge, a survey of consumers who are reported to have experienced myocarditis and/or pericarditis after Pfizer vaccination and their healthcare providers will be undertaken. Information gained through this survey will help us to better understand the safety profile of the Pfizer vaccine, and to inform future recommendations on the use of this vaccine in New Zealand. This project will be conducted by Medsafe, in collaboration with the National Immunisation Programme, and CARM, part of the NZPhvC based at the University of Otago. This study will be an extension of normal pharmacovigilance activities.
Interventions
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes (>3 months) in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine.
The study will be delivered as a survey to consumers and their healthcare provider.
1) The consumer survey will collect d
Myocarditis and pericarditis have been recognised by Medsafe and international regulators as a rare side effect of vaccination with mRNA COVID-19 vaccines, such as the Pfizer vaccine (Comirnaty). More information is needed to understand the long-term outcomes (>3 months) in people who experience myocarditis and/or pericarditis following vaccination with the Pfizer vaccine. The study will be delivered as a survey to consumers and their healthcare provider. 1) The consumer survey will collect data on participant demographics, diagnosis, health and functional status, medicines, and medical history. 2) The healthcare provider survey will include questions on diagnosis and aetiology, tests and investigations, clinical management, and medical history. The consumer survey will be a one-off survey of approximately 30 minutes, these will be delivered primarily through phone interviews conducted by experienced nurse interviewers through a health survey company. The option of face to face interviews will also be available (COVID-19 restrictions permitting) if the participant prefers. Participants will be given the opportunity to provide the name and contact details for their healthcare provider (General Practitioner/Nurse Practitioner or Practice Nurse and/or specialist) and to consent for us to contact them for the purposes of a survey. The healthcare provider survey will be predominantly online, however the option for this to be done by other mechanism will also be available. Participants should have received a diagnosis of myocarditis and/or pericarditis any dose of their Pfizer COVID-19 vaccine between 20 February 2021 and 28 February 2022. People will be contacted to participate between March 2022 and July 2022.
Sponsors
Medsafe
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Adults and children 12 years of age or older with a clinical diagnosis of myocarditis and/or pericarditis (includes myopericarditis), after any dose of the Pfizer vaccine, and their healthcare providers. 2) A report of myocarditis and/or pericarditis has been submitted to the Centre for Adverse Reactions Monitoring (CARM) by the person themselves, or by someone on their behalf (such as a healthcare professional or family member). 3) Participants will not be required to meet specific diagnostic criteria, such as the CDC criteria, to be eligible. 4) Myocarditis and/or pericarditis diagnosed up to and including 28 February 2022, and at least 3 months prior to the survey (minimum of 3 months post-diagnosis).
Exclusion criteria
1) Children <12 years of age. 2) People who have not received a clinical diagnosis of myocarditis and/or pericarditis. This includes self-diagnosis, or where a diagnosis of myocarditis or pericarditis was considered as part of the differential diagnosis but was not given as a final diagnosis. 3) Myocarditis and/or pericarditis diagnosed after 28 February 2022, and/or less than 3 months ago by the end of the specified recruitment period. 4) People who experienced myocarditis and/or pericarditis after a third or subsequent dose of the Pfizer vaccine. 5) People who did not receive the Pfizer vaccine prior to being diagnosed with myocarditis or pericarditis. 6) People who experienced myocarditis and/or pericarditis after vaccination with another COVID-19 vaccine (for example, the AstraZeneca vaccine). 7) People who have not provided sufficient contact information in CARM report to be able to make initial contact. 8) Circumstances that interfere with the participant’s ability to give informed consent (including a diminished understanding or comprehension of English and an interpreter unavailable).
Outcome results
None listed