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

Table of contents

About

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.

Documents

Key facts

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

How useful was this page?

Add your rating
Average
1 rating