Spikevax bivalent Original/Omicron BA.1, pre-filled syringe - Labelling deviation

Table of contents


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.


Key facts

Medicine name
Spikevax (previously COVID-19 Vaccine Moderna)
Active substance
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
Regulatory outcome
DHPC type
Adverse event
Human ATC code

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