COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis

This direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s). It also includes a communication plan with details of intended recipients and the dissemination date.

Medicine name	Comirnaty Spikevax (previously COVID-19 Vaccine Moderna)
Active substance	Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2)
Therapeutic area (MeSH)	COVID-19 virus infection
Procedure number	EMEA/H/C/005735; EMEA/H/C/005791
Regulatory outcome	Variation
DHPC type	Safety signal
Human ATC code	J07BX J07BX03
Dissemination date	19/07/2021

COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis

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Direct healthcare professional communication (DHPC): COVID-19 mRNA Vaccines Comirnaty and Spikevax: risk of myocarditis and pericarditis (PDF/231.38 KB)

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