Comirnaty / Spikevax (previously COVID-19 Vaccine Moderna) - direct healthcare professional communication (DHPC)

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)

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

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

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 codes:
  • J07BX
  • J07BX03
• Dissemination date:
  19/07/2021