Basic Information
Comirnaty
Regulatory Information
EMEA/H/C/005735
December 21, 2020
December 21, 2020
53
March 25, 2025
Company Information
Germany
An der Goldgrube 12 55131 Mainz
BioNTech Manufacturing GmbH
Drug Classification
Active Substances Detail
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
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Comirnaty Original/Omicron BA.4-5 (1.5/1.5 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. Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty Omicron XBB.1.5 (10 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty Omicron XBB.1.5 (10 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 6 months to 4 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty Omicron XBB.1.5 (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. Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty Omicron XBB.1.5 (30 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. The use of this vaccine should be in accordance with official recommendations. Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The use of this vaccine should be in accordance with official recommendations. Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. The use of this vaccine should be in accordance with official recommendations.
Overview Summary
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months. The originally authorised Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19. As SARS-CoV-2 keeps evolving, Comirnaty has been adapted to target the most recent strains of the virus. This helps maintain protection against COVID-19. Therefore, Comirnaty is also authorised as four adapted vaccines, with Comirnaty JN.1 and Comirnaty KP.2 being the most recent: - Comirnaty Original/Omicron BA.4-5 contains tozinameran and famtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2; - Comirnaty Omicron XBB.1.5 contains raxtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2; - Comirnaty JN.1 contains bretovameran, an mRNA molecule with instructions for producing a protein from the Omicron JN.1 subvariant of SARS-CoV-2; - Comirnaty KP.2 contains an mRNA molecule with instructions for producing a protein from the Omicron KP.2 subvariant of SARS-CoV-2. Comirnaty does not contain the virus itself and cannot cause COVID-19.