"Submission details
Initial indication proposed by the sponsor: Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 12 years of age and older...
Indication proposed by Delegate: ... The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment...
Delegate's summary of issues
Data limitations/uncertainties of the submitted data include:
- The long-term efficacy and safety is not known...
ACV advice to the Delegate
... Risks of the vaccine in the 12-15 years age group include increase risks in myocarditis and/or pericarditis and lymphandenopathy. Even apparently mild episodes of myocarditis may lead to long term sequelae, such as arrhythmias. However, additional data from the US suggested that the majority of cases of myocarditis and/or pericarditis after mRNA COVID-19 vaccines (both Pfizer and Moderna)
analysed to date occurred in older adolescents and young adults (aged 16 to 30 years), with highest risk in younger males within days after dose 2."
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