Myocarditis and pericarditis and the COVID-19 vaccine
n late May 2021, the World Health Organization vaccine safety committee noted that myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines are events of special interest for continued evaluation. A small number of case series have emerged from Israel and the United States. The US Centres for Disease Control and Prevention provided recommendations for clinicians and on June 10th presented safety assessments to the Food and Drugs Administration in readiness of review of emergency use authorization of the Moderna mRNA vaccine in adolescents. Available information indicates that: • Symptom onset was usually within a few days after vaccination • Cases were mainly male adolescents and young adults after the second dose; in the US data the median age of cases following 2nd dose was 24 years • Most cases experienced mild illness, responded well to conservative treatment and rest, and their symptoms improved quickly. In the US data analyses, the observed cases exceeded the expected number of cases (based on background rates of myocarditis) following the 2nd dose in the age group 16-24 years. The estimated rate of myocarditis was about 16 cases per million 2nd doses (35 per million in 16-17 year olds; 21 per million in 18-24 year olds). While nine per cent of doses were
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administered in the 12-24 year age group, this group accounted for 53 per cent of myocarditis reports following the 2nd dose. To date, no regulatory action has been taken in Canada or internationally. Additional discussion including a benefit risk assessment are scheduled for review at the US Advisory Committee on Immunization Practices on June 18th.
SITUATION IN CANADA AND BC
As part of ongoing COVID-19 vaccine safety efforts, BC Centre for Disease Control (BCCDC) along with local medical health officers, the Public Health Agency of Canada (PHAC) and Health Canada are closely monitoring myocarditis/pericarditis in passive and active Canadian safety surveillance systems, including the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), the Canada Vigilance Program, the Canadian National Vaccine Safety Network (CANVAS) and the Canadian Immunization Monitoring Program ACTive. In BC and elsewhere in Canada, there have been a small number of reports of pericarditis or myocarditis following vaccination with a COVID-19 mRNA vaccine. In Canada and BC to date, higher rates than would be expected have not yet been observed. The weekly Canadian and BC adverse events following COVID-19 vaccine reports provide updates on the latest numbers.
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