Covid vaccine: Myocarditis and pericarditis study – Medsafe investigates itself

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A study has been launched by New Zealand’s Medsafe to find out if people who developed myocarditis or pericarditis following its approval of the covid-19 Pfizer vaccination had long-term health problems. Anyone over 12, with a clinical diagnosis of myocarditis or pericarditis following a Pfizer vaccination, is eligible to participate.

Dr Tim Hanlon.

See this site for specific study details which shows that the person leading the research is the Ministry of Health’s very own Tim Hanlon – group manager national immunisation programme (he has been in the job since December 2021).

As one commentator said: “You can’t make this sh*t up – have they no concept of conflict of interest”.

(Search for other Kiwi trials here)

Medsafe says international data suggests that for most people who develop myocarditis and/or pericarditis, their symptoms stop with appropriate management. However, there is limited data on the long-term health outcomes of individuals who experience these side effects.  

This study is a collaborative effort across the Ministry of Health, Medsafe, and Centre for Adverse Reactions Monitoring (CARM) to help us to better understand how the Pfizer COVID-19 vaccine is working in Aotearoa New Zealand.

The findings of this study will be published later this year on Medsafe’s website.   

Participants must: 

  • be aged 12 or over 
  • have been diagnosed with myocarditis and/or pericarditis following their first or second dose of the Pfizer COVID-19 vaccine (up to and including 31 December 2021) 
  • have had a report submitted to the Centre for Adverse Reactions Monitoring (CARM).
  • Those who fit these criteria (or the parent/guardian of those under 16 years of age) will be contacted by phone, or letter, and invited to take part in a survey.

If you, or a child in your care, meet this criteria but have not been contacted by the end of April 2022, please email C19myostudy@health.govt.nz if you would like to participate.

Submit a report to CARM 

Anyone who experienced myocarditis or pericarditis after their COVID-19 vaccine and has not yet reported this can submit a CARM report at any time. You can also discuss this with your health care provider, or call the COVID Healthline 0800 358 5453. 

Submit adverse reactions to CARM 

What the study involves 

The survey will be carried out over the phone by trained nurse interviewers from CBG Health Research Limited – a New Zealand company experienced in carrying out health surveys.  

Other options, such as face-to-face or virtual interviews, may be available depending on your preference.  

During the survey, we will also ask permission to contact the healthcare professional who treated you or the child in your care. This is so we can ask for information about medications prescribed and test results so we can get a better understanding of your/their health following myocarditis and/or pericarditis.  

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