tozinameran / riltozinameran and tozinameran / famtozinameran and tozinameran / COVID-19 mRNA Vaccine (nucleoside modified)

Table of contents


On 19 October 2022, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Comirnaty. The marketing authorisation holder for this medicinal product is BioNTech Manufacturing GmbH.

The CHMP adopted an extension to an existing indication to include use of Comirnaty 3 micrograms/dose in children from 6 months of age. The full indication for Comirnaty 3 micrograms/dose will be as follows:

Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.

The use of this vaccine should be in accordance with official recommendations.

For information, the indications for other compositions of the vaccine are provided in the Summary of Product Characteristics for Comirnaty.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • tozinameran
  • riltozinameran and tozinameran
  • famtozinameran and tozinameran
  • COVID-19 mRNA Vaccine (nucleoside modified)
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
Therapeutic area
COVID-19 virus infection
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Date opinion adopted
Company name
BioNTech Manufacturing GmbH
Application type


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